Clinical trial • Phase II • Gastroenterology

ZASOCITINIB for Crohn's disease | Moderately to severely active Crohn's disease

Phase II trial of ZASOCITINIB for Crohn's disease | Moderately to severely active Crohn's disease.

Overview

Trial Therapeutic Area: Gastroenterology
Trial Disease: Crohn's disease | Moderately to severely active Crohn's disease
Trial Stage: Phase II
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 11-03-2024
First CTIS Authorization Date: 01-07-2024

Trial design

Randomised, placebo (tak-279 placebo, same excipient as tak-279) versus tak-279 oral capsules at multiple doses (tak-279 30 mg qd, tak-279 50 mg qd, tak-279 75 mg qd) — oral, once daily (qd) during the induction period.-controlled Phase II trial in France, Hungary, Slovakia and others.

Randomised: Yes
Comparator: Placebo (TAK-279 placebo, same excipient as TAK-279) versus TAK-279 oral capsules at multiple doses (TAK-279 30 mg QD, TAK-279 50 mg QD, TAK-279 75 mg QD) — oral, once daily (QD) during the induction period.
Single Multiple Or Escalation Dose Combined: Yes
Target Sample Size: 149
Trial Duration For Participant: 422

Eligibility

Recruits 149 Vulnerable populations are not selected for this trial (isVulnerablePopulationSelected=false). Only adults are eligible (≥18 and ≤75 years; ≥19 in South Korea). Written informed consent is required prior to any study procedures (documented via a signed and dated ICF) and any required privacy authorizations. The protocol includes specific consent/participant information documents (main ICF, optional genetic consent, pregnant partner information, privacy supplements). No assent process is described because minors are excluded..

Pregnancy Exclusion: Subject has a positive pregnancy test result or plans to become pregnant or donate sperm during the study period, or subject is pregnant or lactating/nursing.
Vulnerable Population: Vulnerable populations are not selected for this trial (isVulnerablePopulationSelected=false). Only adults are eligible (≥18 and ≤75 years; ≥19 in South Korea). Written informed consent is required prior to any study procedures (documented via a signed and dated ICF) and any required privacy authorizations. The protocol includes specific consent/participant information documents (main ICF, optional genetic consent, pregnant partner information, privacy supplements). No assent process is described because minors are excluded.

Inclusion criteria

{"criterion_text":"- The subject is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator. The subject has provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization prior to the initiation of any study procedures.\n- Subjects must be ≥18 and ≤75 years of age at the time of the signing of the ICF. In South Korea, the age requirement for adult subjects is ≥19 years of age.\n- Disease-Specific Inclusion Criteria: Subjects must have active moderate to severe ileal (terminal ileum), ileocolonic, or colonic CD at baseline during screening period as defined by: a) CDAI score between 220 and 450 (inclusive) and b) Presence of ulcerations that are characteristic to CD, as determined by ileocolonoscopy performed during screening, and as defined by the SES-CD ≥6 (SES-CD ≥4 for isolated ileitis)\n- Disease-Specific Inclusion Criteria: Subjects must have a documented diagnosis (endoscopic with histology) of CD for at least 30 days before screening. Documented diagnosis is defined as: a) A biopsy report to confirm the histological diagnosis AND b) A report documenting disease duration based upon prior ileocolonoscopy. Note: If a biopsy report is not available in the source document at the time of screening, a local histology report of a biopsy performed during the screening ileocolonoscopy should be consistent with a CD diagnosis. If the histology diagnosis is not clear and the endoscopy is inconsistent with CD at this time point, the subject will not be randomized.\n- Disease-Specific Inclusion Criteria: Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, aged >50 years, or other known risk factors must be up to date on colorectal cancer surveillance (may be performed during screening).\n- Disease-Specific Inclusion Criteria: Subjects must be willing and able to undergo ileocolonoscopy with biopsies during screening after all other inclusion criteria have been met.\n- Prior Treatment Failure Criteria: Subjects with a history of inadequate response to, loss of response to, or intolerance to one or more of these therapies for CD based on Physician assessment: (according to either (a) or (b) below or a combination of both) (Details provided in Appendix 2).: a) 6-mercaptopurine or azathioprine, oral or IV corticosteroids or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of CD symptoms), oral 5-ASAs AND/OR b) Biologic agents (such as TNF antagonists, antibodies to IL-23p19, IL-12/23p40, vedolizumab) or any advanced therapy (such as JAKi or S1P receptor modulators).\n- Other General Inclusion Criteria: 8. Subjects are (CCI). For individuals of reproductive potential, if sexually active, agree to comply with the contraceptive requirements for the duration of the study and 10 days after the last dose of the study drug. The following birth control requirements must be met: b) Female (sex-assigned at birth) subjects must be surgically sterile or be of nonchildbearing potential with confirmation of postmenopausal status (ie, follicle-stimulating hormone level >40 mIU/mL); or, if sexually active with a nonsterilized individual who produces sperm agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the study"}

Exclusion criteria

{"criterion_text":"- Exclusion Criteria Related to GI Tract: Subjects with IBD indeterminate or unclassified, microscopic colitis, ischemic colitis, infectious colitis, or radiation colitis, and diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of ulcerative colitis.\n- Exclusion Criteria Related to GI Tract: Subjects with evidence or suspicion of liver disease or primary sclerosing cholangitis.\n- Exclusion Criteria related to Medication:\n- Exclusion Criteria Related to Other Prohibited Concomitant Medications: Subjects on CD-related antibiotics who have not been on stable doses for greater than or discontinued within 14 days prior to the first administration of study drug.\n- Exclusion Criteria Related to Other Prohibited Concomitant Medications: Subjects on oral 5-ASAs who have not been on stable doses for greater than, or discontinued within, at least 14 days prior to the first administration of study drug or receiving mesalamine >4.8g/day (or equivalent).\n- Subjects on high dose corticosteriods\n- Subjects on prohibited medications as listed in the protocol\n- Exclusion Criteria related to Infectious Diseases: Tuberculosis (TB): a) Subject has current active TB infection, regardless of treatment status. b) Subject who has positive QuantiFERON will require to start treatment for latent TB at least 2 weeks prior to randomization. c) Subject has a positive QuantiFERON-TB Gold (QFT) or T-Spot, TB skin test (TST) result or 2 indeterminate QFT or TST results. TST is considered positive if reaction ≥10 mm, unless there are no signs/symptoms of active TB and documentation of prior and complete treatment for latent TB (appropriate in duration and type according to current local country guidelines) has been completed or subject has initiated prophylaxis based on local guidelines a minimum of 2 weeks prior to the first administration of study drug and documentation of no history of active TB can be provided. Note: TB prophylaxis regimens should be administered according to local guidelines. However, because of potential interactions with TAK-279, rifampin should not be used. Note: QFT or TST may be used based on country and site-specific guidelines. d) Subject has had any imaging study during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active of TB.\n- Exclusion Criteria related to Infectious Diseases: Herpes infections: a) Subject has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or prior to the first administration of study drug, b) Subject has a history of herpetic infection within 8 weeks prior to screening. c) Subject has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes simplex virus, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).\n- Non-herpetic viral diseases: a) Subject has presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (nucleic acid test or polymerase chain reaction). b) Subject has presence of positive hepatitis B surface antigen (HBsAg+), presence of hepatitis B virus DNA, or positive anti-hepatitis B core antibody without concurrent positive hepatitis B surface antibody (HBcAb+ and HBsAb-). c) Subject has positive results for HIV by serology, regardless of viral load.\n- Other infectious diseases: a) Subject has history of symptoms suggestive of systemic or invasive infection within 30 days prior to the first administration of study drug. b) Subject has history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to the first administration of study drug, or oral antimicrobial therapy within 30 days prior to the first administration of study drug. c) Subject has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial onychomycosis). d) Subject has a history of an infected joint prosthesis unless that prosthesis has been removed or replaced within 60 days prior to the first administration of study drug. e) Subject has a history of opportunistic infections. f) Subjects with active enteric infections within 4 weeks prior to the first administration of study drug. g) Subject has active CMV colitis requiring treatment in last 2 weeks prior to the first administration of study drug.\n- Exclusion Criteria Related to GI Tract: Have complications of CD such as strictures, stenoses, short gut syndrome, or any other manifestation that might require surgery during the study, could preclude the use of the CDAI/PRO2 to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with TAK-279.\n- Exclusion Criteria related to Health: Noninfectious Disorders Exclusions: Subject has any clinically significant medical condition, evidence of an unstable clinical condition (eg, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/ ECG abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.\n- Exclusion Criteria related to Laboratory Investigations: Subject has inadequate renal or hepatic function before randomization based on the following parameters: a) Total bilirubin ≥1.5 × ULN unless the subject has known Gilbert’s syndrome that can explain the elevation of bilirubin, or b) Serum ALT or AST ≥3 × ULN, or c) Creatinine >1.5 × ULN. d) Estimated creatinine clearance <45 mL/min based on the Cockcroft-Gault calculation.\n- Exclusion Criteria related to Laboratory Investigations: Subject with any of the following laboratory values at the screening visit: a) Hemoglobin <9.0 g/dL (<90.0 g/L) b) Absolute white blood cell count <3.0 × 109/L (<3000/mm3) c) Absolute neutrophil count of <1.2 × 109/L (<1200/mm3) d) Absolute lymphocyte count of <0.75 × 109/L (<750/mm3) e) Platelet count <100 × 109/L g) Thyroid-stimulating hormone (TSH), free T4 (thyroxine) or T3 (triiodothyronine) outside the normal reference range. h) Subject has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. i) CPK > ULN.\n- Other General Exclusion Criteria: Subject does not tolerate venipuncture or inability to be venipunctured.\n- Allergies and Adverse Drug Reactions Exclusions: a) Subject has history of significant drug allergy (such as anaphylaxis). b) Subject has a known or suspected intolerance, hypersensitivity, or allergy to TAK-279 or any of its components.\n- Subject has a positive pregnancy test result or plans to become pregnant or donate sperm during the study period, or subject is pregnant or lactating/nursing.\n- Subjects who have given greater than 500 mL of blood or plasma within 30 days of screening (during a clinical trial or at a blood bank donation) or plans to donate blood during the study.\n- Subject is compulsorily detained for treatment of either a psychiatric or physical illness.\n- Subject is a study site employee, an immediate family member (eg, spouse, parent, child, sibling), or is in a dependent relationship with a study site employee who is involved in conduct of this study or may consent under duress.\n- Exclusion Criteria Related to GI Tract: Have any current or prior abscesses unless they have been drained and treated at least 6 weeks prior to randomization and are not anticipated to require surgery during the treatment period. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present.\n- Exclusion Criteria Related to GI Tract: Subjects with presence of enterovesical (ie, between the bowel and urinary bladder) or enterovaginal fistulae.\n- Exclusion Criteria Related to GI Tract: Have had any kind of bowel resection or diversion within 6 months or any other intraabdominal surgery within 3 months prior to screening. Subjects with >2 bowel resections, subtotal colectomy, or proctocolectomy are excluded.\n- Exclusion Criteria Related to GI Tract: Subjects with a current ileostomy or colostomy. Subjects who had a j-pouch are excluded as a j-pouch could result in a stoma.\n- Exclusion Criteria Related to GI Tract: Subjects with obstructive/ symptomatic colonic stricture may require surgery for CD during treatment period.\n- Exclusion Criteria Related to GI Tract: Subjects with past medical history or presence of toxic megacolon.\n- Exclusion Criteria Related to GI Tract: Subjects with gastrointestinal dysplasia or neoplasia except history of adenomatous polyps that have been completely removed."}

Endpoints

Primary endpoints

{"endpoint_text":"- Endoscopic response at Week 12, assessed as proportion of subjects achieving decrease in Simple Endoscopic Score for Crohn’s Disease (SES‑CD) >50% from baseline (or for subjects with isolated ileal disease, SES-CD ≤4 or at least a 2‑point reduction from baseline) read centrally.","definition_or_measurement_approach":"Assessed as the proportion of subjects achieving >50% decrease in SES-CD from baseline (or SES-CD ≤4 or ≥2‑point reduction for isolated ileal disease); endoscopies read centrally."}

Secondary endpoints

{"endpoint_text":"- 01. Clinical remission at Week 12, assessed as proportion of subjects achieving CD Activity Index (CDAI)<150.","definition_or_measurement_approach":"Proportion of subjects with CDAI <150 at Week 12."}
{"endpoint_text":"- 02. Clinical response at Week 12, assessed as proportion of subjects achieving reduction of CDAI from baseline of >100.","definition_or_measurement_approach":"Proportion of subjects with ≥100-point reduction in CDAI from baseline at Week 12."}
{"endpoint_text":"- 03. Endoscopic remission at Week 12, assessed as proportion of subjects achieving SES-CD ≤4 or ≤2 for ileal disease, no subscore >1.","definition_or_measurement_approach":"Proportion of subjects with SES-CD ≤4 (≤2 for ileal disease) and no subscore >1 at Week 12; centrally read."}
{"endpoint_text":"- 04. Clinical remission in two patient-reported outcome items (PRO2) of the CDAI at Week 12, assessed as proportion of subjects with average daily liquid or very soft stool frequency (SF) score ≤2.8 and not worse than baseline and average daily abdominal pain (AP) score ≤1 and not worse than baseline.","definition_or_measurement_approach":"Proportion of subjects meeting PRO2 thresholds: average daily SF ≤2.8 (and not worse than baseline) AND average daily AP ≤1 (and not worse than baseline) at Week 12."}
{"endpoint_text":"- 05. Clinical response in PRO2 at Week 12, assessed as proportion of subjects with ≥30% decrease in average daily very soft or liquid stools and/ or ≥30% decrease in average AP from baseline.","definition_or_measurement_approach":"Proportion of subjects with ≥30% reduction in average daily very soft/liquid stool frequency and/or ≥30% reduction in average abdominal pain (AP) from baseline at Week 12."}
{"endpoint_text":"- 06. Proportion of subjects with no bowel urgency as measured by the bowel urgency eDiary item at Week 12.","definition_or_measurement_approach":"Proportion of subjects reporting no bowel urgency on the eDiary bowel urgency item at Week 12."}
{"endpoint_text":"- 07. Disease-specific health-related quality of life (HRQoL) as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 12, assessed as proportion of subjects with total score ≥170.","definition_or_measurement_approach":"Proportion of subjects with IBDQ total score ≥170 at Week 12."}
{"endpoint_text":"- 08. Change from baseline in disease-specific HRQoL as measured by the IBDQ total score at Week 12.","definition_or_measurement_approach":"Change from baseline in IBDQ total score at Week 12."}
{"endpoint_text":"- 09. Change from baseline in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score at Week 12.","definition_or_measurement_approach":"Change from baseline in FACIT-Fatigue score at Week 12."}

Recruitment

Digital Remote Recruitment: True, methods include programmatic/search ads, social media videos, Trialbee digital pre-screening tools and online study landing pages and digital recruitment content for multiple languages.
Planned Sample Size: 149
Recruitment Window Months: 36
Consent Approach: Written informed consent is required prior to any study procedures, documented via a signed and dated ICF; participants provide consent themselves (adults only; age ≥18, with Korea-specific adult age ≥19). Separate/optional consent documents exist for genetic research, pregnant partner information and future research; privacy authorisation/notice supplements are used. Consent materials are available in multiple translations (examples in the dossier include English and translations such as Greek, French, Dutch, Hungarian, Polish, Bulgarian, Slovak and others).

Methods

Digital advertising: programmatic/search ads and program digital ads (e.g., 'Program Search Ads', 'Program Digital Ads', social media video scripts) to drive patient interest.
TrialBee platform and other digital patient-identification platforms (Trialbee self-assessment / secondary assessment) for online pre-screening.
Advocacy outreach: advocacy emails and advocacy messages (materials titled 'Advocacy Email', 'Advocacy Messages') to patient organizations and groups.
Physician-to-patient communication: 'Doctor to Patient Email' templates to be used by investigators to notify patients.
Site-based recruitment materials: recruitment brochures, posters, appointment reminder cards, patient messaging and site master screener to identify and screen potential participants at clinic sites.
Third-party recruitment/engagement vendors (e.g., Clinical Trial Media, Scout Clinical) to support patient recruitment and study start-up activities.

Geography

Total Number Of Sites: 90
Total Number Of Participants: 149

France

Earliest CTIS Part Ii Submission Date: 30-04-2024
Latest Decision Or Authorization Date: 03-07-2024
Processing Time Days: 64
Number Of Sites: 7
Number Of Participants: 10

Sites

Site Name: University Hospital Of Clermont-Ferrand
Department Name: Digestive medicine
Principal Investigator Name: Anthony Buisson
Principal Investigator Email: a_buisson@chu-clermontferrand.fr
Contact Person Name: Anthony Buisson
Contact Person Email: a_buisson@chu-clermontferrand.fr

Site Name: Centre Hospitalier Regional Universitaire De Tours
Department Name: Hépato-gastro-enterology
Principal Investigator Name: Driffa Moussata
Principal Investigator Email: d.moussata@chu-tours.fr
Contact Person Name: Driffa Moussata
Contact Person Email: d.moussata@chu-tours.fr

Site Name: Hopital Saint Antoine
Department Name: Gastroenterology and nutrition
Principal Investigator Name: Julien Kirchgesner
Principal Investigator Email: julien.kirchgesner@aphp.fr
Contact Person Name: Julien Kirchgesner
Contact Person Email: julien.kirchgesner@aphp.fr

Site Name: Centre Hospitalier Universitaire De Nice
Department Name: Gastroenterology department
Principal Investigator Name: Adrien Nicolau
Principal Investigator Email: nicolau.a@chu-nice.fr
Contact Person Name: Adrien Nicolau
Contact Person Email: nicolau.a@chu-nice.fr

Site Name: CHRU De Nancy
Department Name: Gastroenterology - Clinical investigation unit
Principal Investigator Name: Bénédicte Caron
Principal Investigator Email: b.caron@chru-nancy.fr
Contact Person Name: Bénédicte Caron
Contact Person Email: b.caron@chru-nancy.fr

Site Name: Centre Hospitalier Universitaire De Saint Etienne
Department Name: Gastroenterology
Principal Investigator Name: Xavier Roblin
Principal Investigator Email: xavier.roblin@chu-st-etienne.fr
Contact Person Name: Xavier Roblin
Contact Person Email: xavier.roblin@chu-st-etienne.fr

Site Name: Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name: Institut des MICI
Principal Investigator Name: Yoram Bouhnik
Principal Investigator Email: yoram.bouhnik@institutdesmici.fr
Contact Person Name: Yoram Bouhnik
Contact Person Email: yoram.bouhnik@institutdesmici.fr

Hungary

Earliest CTIS Part Ii Submission Date: 20-06-2024
Latest Decision Or Authorization Date: 04-07-2024
Processing Time Days: 14
Number Of Sites: 4
Number Of Participants: 6

Sites

Site Name: Semmelweis University
Department Name: Transzplantációs és Gasztroenterológiai Klinika
Principal Investigator Name: Pál Miheller
Principal Investigator Email: miheller.pal@semmelweis.hu
Contact Person Name: Pál Miheller
Contact Person Email: miheller.pal@semmelweis.hu

Site Name: Pannonia Maganorvosi Centrum Kft.
Principal Investigator Name: Róbert Schnábel
Principal Investigator Email: schnabelrobert@hotmail.com
Contact Person Name: Róbert Schnábel
Contact Person Email: schnabelrobert@hotmail.com

Site Name: Clinexpert Kft.
Principal Investigator Name: Gábor Tamás Tóth
Principal Investigator Email: medicatorbt@gmail.com
Contact Person Name: Gábor Tamás Tóth
Contact Person Email: medicatorbt@gmail.com

Site Name: EURO-ENDO-MED Kft.
Principal Investigator Name: Csaba Csizmadia
Principal Investigator Email: csizmadia.csaba@pte.hu
Contact Person Name: Csaba Csizmadia
Contact Person Email: csizmadia.csaba@pte.hu

Slovakia

Earliest CTIS Part Ii Submission Date: 28-06-2024
Latest Decision Or Authorization Date: 03-07-2024
Processing Time Days: 5
Number Of Sites: 5
Number Of Participants: 6

Sites

Site Name: Fakultna Nemocnica S Poliklinikou Nove Zamky
Department Name: Gastroenterologická ambulancia
Principal Investigator Name: Juraj Ďurina
Principal Investigator Email: jdurina@gmail.com
Contact Person Name: Juraj Ďurina
Contact Person Email: jdurina@gmail.com

Site Name: F D Roosevelt University General Hospital Of Banska Bystrica
Department Name: Gastroenterologická ambulancia
Principal Investigator Name: Jozef Baláž
Principal Investigator Email: balaz@scouting.sk
Contact Person Name: Jozef Baláž
Contact Person Email: balaz@scouting.sk

Site Name: Accout Center s.r.o.
Principal Investigator Name: František Horváth
Principal Investigator Email: fhorvath.studie@gmail.com
Contact Person Name: František Horváth
Contact Person Email: fhorvath.studie@gmail.com

Site Name: Endomed s.r.o.
Department Name: Gastroenterologická ambulancia
Principal Investigator Name: Miroslav Fedurco
Principal Investigator Email: fedurco@endomed.sk
Contact Person Name: Miroslav Fedurco
Contact Person Email: fedurco@endomed.sk

Site Name: Cliniq s.r.o.
Department Name: Gastroenterologická ambulancia
Principal Investigator Name: Tibor Hlavatý
Principal Investigator Email: tibor.hlavaty2@gmail.com
Contact Person Name: Tibor Hlavatý
Contact Person Email: tibor.hlavaty2@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date: 25-06-2024
Latest Decision Or Authorization Date: 01-07-2024
Processing Time Days: 6
Number Of Sites: 6
Number Of Participants: 9

Sites

Site Name: Aalborg University Hospital
Department Name: Department of Medical Gastroenterology
Principal Investigator Name: Jan Fallinborg
Principal Investigator Email: jaf@rn.dk
Contact Person Name: Jan Fallinborg
Contact Person Email: jaf@rn.dk

Site Name: Hvidovre Hospital
Department Name: Gastroenterologist at Gastrounit, medical section
Principal Investigator Name: Johan Michael Burisch
Principal Investigator Email: Johan.burisch@regionh.dk
Contact Person Name: Johan Michael Burisch
Contact Person Email: Johan.burisch@regionh.dk

Site Name: Esbjerg Og Grindsted Sygehus
Department Name: Department of Internal Medicine, Section of Gastroenterology
Principal Investigator Name: Michael Jensen
Principal Investigator Email: Michael.Dam.Jensen@rsyd.dk
Contact Person Name: Michael Jensen
Contact Person Email: Michael.Dam.Jensen@rsyd.dk

Site Name: Hillerod Hospital
Department Name: Clinical Research Unit
Principal Investigator Name: Salvatore Leotta
Principal Investigator Email: Salvatore.leotta.02@regionh.dk
Contact Person Name: Salvatore Leotta
Contact Person Email: Salvatore.leotta.02@regionh.dk

Site Name: Odense University Hospital
Department Name: Department of Medical Gastroenterology
Principal Investigator Name: Jens Kjeldsen
Principal Investigator Email: jens.kjeldsen@rsyd.dk
Contact Person Name: Jens Kjeldsen
Contact Person Email: jens.kjeldsen@rsyd.dk

Site Name: Region Sjaelland
Department Name: Section of Gastroenterology, Department of Internal Medicine
Principal Investigator Name: Nynne Andersen
Principal Investigator Email: nyna@regionsjaelland.dk
Contact Person Name: Nynne Andersen
Contact Person Email: nyna@regionsjaelland.dk

Greece

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 04-07-2024
Processing Time Days: 27
Number Of Sites: 6
Number Of Participants: 8

Sites

Site Name: General Hospital Of Athens G Gennimatas
Department Name: Gastroenterology Clinic
Principal Investigator Name: Georgios Michalopoulos
Principal Investigator Email: gmicha78@hotmail.com
Contact Person Name: Georgios Michalopoulos
Contact Person Email: gmicha78@hotmail.com

Site Name: Alexandra Hospital
Department Name: Gastroenterology Department
Principal Investigator Name: Evanthia Zampeli
Principal Investigator Email: evazamb@gmail.com
Contact Person Name: Evanthia Zampeli
Contact Person Email: evazamb@gmail.com

Site Name: Thoracic General Hospital Of Athens I Sotiria
Department Name: 3rd Academic Department of Internal Medicine
Principal Investigator Name: Georgios Bamias
Principal Investigator Email: gbamias@gmail.com
Contact Person Name: Georgios Bamias
Contact Person Email: gbamias@gmail.com

Site Name: University General Hospital Of Heraklion
Department Name: Gastroenterology Department
Principal Investigator Name: Ioannis Koutroubakis
Principal Investigator Email: ikoutroub@med.uoc.gr
Contact Person Name: Ioannis Koutroubakis
Contact Person Email: ikoutroub@med.uoc.gr

Site Name: General University Hospital Of Patras
Department Name: Gastroenterology Department
Principal Investigator Name: Konstantinos Thomopoulos
Principal Investigator Email: kxthomo@hotmail.com
Contact Person Name: Konstantinos Thomopoulos
Contact Person Email: kxthomo@hotmail.com

Site Name: Evaggelismos Hospital
Department Name: Gastroenterology Department
Principal Investigator Name: Nikolaos Viazis
Principal Investigator Email: nikos.viazis@gmail.com
Contact Person Name: Nikolaos Viazis
Contact Person Email: nikos.viazis@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date: 07-06-2024
Latest Decision Or Authorization Date: 01-07-2024
Processing Time Days: 24
Number Of Sites: 3
Number Of Participants: 6

Sites

Site Name: Elisabeth-Tweesteden Ziekenhuis
Department Name: Gastroenterology and hepatology
Principal Investigator Name: Robert Laheij
Principal Investigator Email: r.laheij@etz.nl
Contact Person Name: Robert Laheij
Contact Person Email: r.laheij@etz.nl

Site Name: Zuyderland Medisch Centrum Stichting
Department Name: MDL
Principal Investigator Name: Adriaan Van Bodegraven
Principal Investigator Email: trialbureau.interne@zuyderland.nl
Contact Person Name: Adriaan Van Bodegraven
Contact Person Email: trialbureau.interne@zuyderland.nl

Site Name: Amsterdam UMC Stichting
Department Name: Gastroenterology and Hepatology
Principal Investigator Name: Krisztina Gecse
Principal Investigator Email: k.b.gecse@amsterdamumc.nl
Contact Person Name: Krisztina Gecse
Contact Person Email: k.b.gecse@amsterdamumc.nl

Belgium

Earliest CTIS Part Ii Submission Date: 18-06-2024
Latest Decision Or Authorization Date: 02-07-2024
Processing Time Days: 14
Number Of Sites: 4
Number Of Participants: 8

Sites

Site Name: Hopital Erasme
Department Name: Gastroenterology
Principal Investigator Name: Denis Franchimont
Principal Investigator Email: Denis.franchimont@erasme.ulb.ac.be
Contact Person Name: Denis Franchimont
Contact Person Email: Denis.franchimont@erasme.ulb.ac.be

Site Name: CHU Saint Pierre
Department Name: Gastroenterology
Principal Investigator Name: Vinciane Muls
Principal Investigator Email: vinciane_muls@stpierre-bru.be
Contact Person Name: Vinciane Muls
Contact Person Email: vinciane_muls@stpierre-bru.be

Site Name: UZ Leuven
Department Name: Gastroenterology and hepatology
Principal Investigator Name: João Pedro Guedelha Sabino
Principal Investigator Email: joao.sabino@uzleuven.be
Contact Person Name: João Pedro Guedelha Sabino
Contact Person Email: joao.sabino@uzleuven.be

Site Name: Centre hospitalier universitaire de Liege
Department Name: Gastroenterology
Principal Investigator Name: Catherine Reenaers
Principal Investigator Email: Catherine.Reenaers@chuliege.be
Contact Person Name: Catherine Reenaers
Contact Person Email: Catherine.Reenaers@chuliege.be

Italy

Earliest CTIS Part Ii Submission Date: 24-06-2024
Latest Decision Or Authorization Date: 03-07-2024
Processing Time Days: 39
Number Of Sites: 7
Number Of Participants: 11

Sites

Site Name: San Camillo Forlanini Hospital
Department Name: Gastroenterology and Digestive Endoscopy Unit
Principal Investigator Name: Rocco Cosintino
Principal Investigator Email: rcosintino@scamilloforlanini.rm.it
Contact Person Name: Rocco Cosintino
Contact Person Email: rcosintino@scamilloforlanini.rm.it

Site Name: Azienda Ospedaliero-Universitaria Di Bologna
Department Name: Medical surgical department of digestive, liver and endocrinemetabolic diseases
Principal Investigator Name: Fernando Rizzello
Principal Investigator Email: fernando.rizzello@unibo.it
Contact Person Name: Fernando Rizzello
Contact Person Email: fernando.rizzello@unibo.it

Site Name: Humanitas Research Hospital
Department Name: IBD Center
Principal Investigator Name: Alessandro Armuzzi
Principal Investigator Email: alessandro.armuzzi@hunimed.eu
Contact Person Name: Alessandro Armuzzi
Contact Person Email: alessandro.armuzzi@hunimed.eu

Site Name: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name: Gastroenterology and Endoscopy Unit
Principal Investigator Name: Flavio Andrea Caprioli
Principal Investigator Email: flavio.caprioli@policlinico.mi.it
Contact Person Name: Flavio Andrea Caprioli
Contact Person Email: flavio.caprioli@policlinico.mi.it

Site Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name: Internal Medicine and Gastroenterology Unit
Principal Investigator Name: Antonio Gasbarrini
Principal Investigator Email: antonio.gasbarrini@unicatt.it
Contact Person Name: Antonio Gasbarrini
Contact Person Email: antonio.gasbarrini@unicatt.it

Site Name: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name: MICI Unit - Via Trabucco 180, Palermo, 90146
Principal Investigator Name: Ambrogio Orlando
Principal Investigator Email: ambrogioorlando@ospedaliriunitipalermo.it
Contact Person Name: Ambrogio Orlando
Contact Person Email: ambrogioorlando@ospedaliriunitipalermo.it

Site Name: Ospedale San Raffaele S.r.l.
Department Name: Gastroenterology and Endoscopy Unit
Principal Investigator Name: Silvio Danese
Principal Investigator Email: danese.silvio@hrs.it
Contact Person Name: Silvio Danese
Contact Person Email: danese.silvio@hrs.it

Poland

Earliest CTIS Part Ii Submission Date: 20-06-2024
Latest Decision Or Authorization Date: 02-07-2024
Processing Time Days: 12
Number Of Sites: 13
Number Of Participants: 23

Sites

Site Name: Melita Medical Sp. z o.o.
Department Name: Centrum Medyczne Melita Medical
Principal Investigator Name: Jarosław Leszczyszyn
Principal Investigator Email: j.leszczyszyn@melitamedical.pl
Contact Person Name: Jarosław Leszczyszyn
Contact Person Email: j.leszczyszyn@melitamedical.pl

Site Name: Korczowski Bartosz, Gabinet Lekarski
Principal Investigator Name: Bartosz Korczowski
Principal Investigator Email: korczowski@op.pl
Contact Person Name: Bartosz Korczowski
Contact Person Email: korczowski@op.pl

Site Name: Planetmed Sp. z o.o.
Principal Investigator Name: Barbara Woźniak-Stolarska
Principal Investigator Email: basiastolarska@interia.pl
Contact Person Name: Barbara Woźniak-Stolarska
Contact Person Email: basiastolarska@interia.pl

Site Name: Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name: Twoja Przychodnia SCM
Principal Investigator Name: Beata Gawdis-Wojnarska
Principal Investigator Email: scm@twojaprzychodnia.com
Contact Person Name: Beata Gawdis-Wojnarska
Contact Person Email: scm@twojaprzychodnia.com

Site Name: Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Department Name: Centrum Badań Klinicznych Ośrodek Badań Wczesnej Fazy
Principal Investigator Name: Piotr Napora
Principal Investigator Email: napora.piotr@cbk.wroc.pl
Contact Person Name: Piotr Napora
Contact Person Email: napora.piotr@cbk.wroc.pl

Site Name: Centrum Medyczne Med-Gastr Sp. z o.o.
Principal Investigator Name: Arkadiusz Mamos
Principal Investigator Email: amamos@wp.pl
Contact Person Name: Arkadiusz Mamos
Contact Person Email: amamos@wp.pl

Site Name: Pro Life Medica Sp. z o.o.
Department Name: ETG Zamosc
Principal Investigator Name: Katarzyna Wójcik
Principal Investigator Email: k.wojcik@etg-network.com
Contact Person Name: Katarzyna Wójcik
Contact Person Email: k.wojcik@etg-network.com

Site Name: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name: Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej
Principal Investigator Name: Ewa Małecka-Wojciesko
Principal Investigator Email: ewa.malecka-panas@umed.lodz.pl
Contact Person Name: Ewa Małecka-Wojciesko
Contact Person Email: ewa.malecka-panas@umed.lodz.pl

Site Name: Gastromed Sp. z o.o.
Department Name: Toruńskie Centrum Gastrologiczne "Gastromed"
Principal Investigator Name: Adam Kopoń
Principal Investigator Email: gastromedtrials@gmail.com
Contact Person Name: Adam Kopoń
Contact Person Email: gastromedtrials@gmail.com

Site Name: Amicare Sp. z o.o. sp.k.
Department Name: Amicare Centrum Medyczne
Principal Investigator Name: Rafał Drozda
Principal Investigator Email: r.drozda@amicare.pl
Contact Person Name: Rafał Drozda
Contact Person Email: r.drozda@amicare.pl

Site Name: Medical Network Sp. z o.o.
Department Name: WIP Warsaw IBD Point Profesor Kierkus
Principal Investigator Name: Jarosław Kierkuś
Principal Investigator Email: j.kierkus@med-net.pl
Contact Person Name: Jarosław Kierkuś
Contact Person Email: j.kierkus@med-net.pl

Site Name: Centrum Medyczne Medis
Department Name: Centrum Medyczne "Medis"
Principal Investigator Name: Maria Klopocka
Principal Investigator Email: clinicaltrials@cm-medis.pl
Contact Person Name: Maria Klopocka
Contact Person Email: clinicaltrials@cm-medis.pl

Site Name: H-T.Centrum Medyczne Sp. z o.o. sp.k.
Department Name: H-T. Centrum Medyczne - Endoterapia
Principal Investigator Name: Tomasz Romańczyk
Principal Investigator Email: romanczyk@htcentrum.pl
Contact Person Name: Tomasz Romańczyk
Contact Person Email: romanczyk@htcentrum.pl

Romania

Earliest CTIS Part Ii Submission Date: 26-06-2024
Latest Decision Or Authorization Date: 08-07-2024
Processing Time Days: 12
Number Of Sites: 6
Number Of Participants: 7

Sites

Site Name: Spitalul Clinic Dr. I. Cantacuzino
Department Name: Medical Gastroenterology
Principal Investigator Name: Bogdan Busuioc
Principal Investigator Email: bogbusuioc@gmail.com
Contact Person Name: Bogdan Busuioc
Contact Person Email: bogbusuioc@gmail.com

Site Name: Monza-Ares S.R.L.
Department Name: Departament Clinic de Gastroenterologie
Principal Investigator Name: Theodor Alexandru Voiosu
Principal Investigator Email: theodor.voiosu@gmail.com
Contact Person Name: Theodor Alexandru Voiosu
Contact Person Email: theodor.voiosu@gmail.com

Site Name: Institutul Clinic Fundeni
Department Name: Sectia de Gastroenterologie
Principal Investigator Name: Carmen Monica Preda
Principal Investigator Email: preda_monicaa@yahoo.com
Contact Person Name: Carmen Monica Preda
Contact Person Email: preda_monicaa@yahoo.com

Site Name: Delta Health Care S.R.L.
Department Name: Medical Gastroenterology
Principal Investigator Name: Camelia Chioncel
Principal Investigator Email: alis.mihai@reginamaria.ro
Contact Person Name: Camelia Chioncel
Contact Person Email: alis.mihai@reginamaria.ro

Site Name: Spitalul Clinic Colentina Bucuresti
Department Name: Departament Clinic de Medicina Interna si Gastroenterologie
Principal Investigator Name: Radu Bogdan Mateescu
Principal Investigator Email: bogmateescu@gmail.com
Contact Person Name: Radu Bogdan Mateescu
Contact Person Email: bogmateescu@gmail.com

Site Name: Cabinet Particular Policlinic Algomed S.R.L.
Department Name: Departament Clinic de Medicina Interna si Gastroenterologie
Principal Investigator Name: Adrian Eugen Goldis
Principal Investigator Email: goldisadi@yahoo.com
Contact Person Name: Adrian Eugen Goldis
Contact Person Email: goldisadi@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date: 25-06-2024
Latest Decision Or Authorization Date: 03-07-2024
Processing Time Days: 8
Number Of Sites: 7
Number Of Participants: 13

Sites

Site Name: Universitaetsklinikum Tuebingen AöR
Department Name: Medizinische Klinik, Innere Medizin I, Gastroendterologie, Hepatologie, Infektiologie
Principal Investigator Name: Karsten Büringer
Principal Investigator Email: karsten.bueringer@med.uni-tuebingen.de
Contact Person Name: Karsten Büringer
Contact Person Email: karsten.bueringer@med.uni-tuebingen.de

Site Name: Universitaetsklinikum Ulm AöR
Department Name: Center of Internal Medicine, Internal Medicine I
Principal Investigator Name: Jochen Gerhard Klaus
Principal Investigator Email: jochen.klaus@uniklinik-ulm.de
Contact Person Name: Jochen Gerhard Klaus
Contact Person Email: jochen.klaus@uniklinik-ulm.de

Site Name: Goethe University Frankfurt
Department Name: Medizinische Klinik I
Principal Investigator Name: Irina Blumenstein
Principal Investigator Email: Blumenstein@em.unifrankfurt.de
Contact Person Name: Irina Blumenstein
Contact Person Email: Blumenstein@em.unifrankfurt.de

Site Name: Universitaetsklinikum Mannheim GmbH
Department Name: Medizinische Klinik
Principal Investigator Name: Wolfgang Reindl
Principal Investigator Email: Wolfgang.reindl@umm.de
Contact Person Name: Wolfgang Reindl
Contact Person Email: Wolfgang.reindl@umm.de

Site Name: St. Marien Und St. Annastiftskrankenhaus
Department Name: Klinik für Innere Medizin Gastroenterologie, Kardiologie, Pneumologie Palliativmedizin, Diabetologie
Principal Investigator Name: Tanja Kuehbacher
Principal Investigator Email: Tanja.kuehbacher@stmarienkrankenhaus.de
Contact Person Name: Tanja Kuehbacher
Contact Person Email: Tanja.kuehbacher@stmarienkrankenhaus.de

Site Name: Universitaetsklinikum Schleswig-Holstein AöR
Department Name: Klinik für Innere Medizin I
Principal Investigator Name: Stefan Schreiber
Principal Investigator Email: s.schreiber@mucosa.de
Contact Person Name: Stefan Schreiber
Contact Person Email: s.schreiber@mucosa.de

Site Name: Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name: Gastorenterology
Principal Investigator Name: Axel Dignass
Principal Investigator Email: axel.dignass@agaplesion.de
Contact Person Name: Axel Dignass
Contact Person Email: axel.dignass@agaplesion.de

Bulgaria

Earliest CTIS Part Ii Submission Date: 16-05-2025
Latest Decision Or Authorization Date: 06-06-2025
Processing Time Days: 21
Number Of Sites: 6
Number Of Participants: 8

Sites

Site Name: Diagnostic-Consultative Center Alexandrovska EOOD
Principal Investigator Name: Diana Stefanova-Petrova
Principal Investigator Email: prof.petrova@mail.com
Contact Person Name: Diana Stefanova-Petrova
Contact Person Email: prof.petrova@mail.com

Site Name: Acibadem City Clinic University Hospital EOOD
Department Name: Gastroenterology clinic
Principal Investigator Name: Asen Petrov
Principal Investigator Email: dr_assenp@abv.bg
Contact Person Name: Asen Petrov
Contact Person Email: dr_assenp@abv.bg

Site Name: Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Department Name: Gastroenterology department
Principal Investigator Name: Dimitar Pavlov
Principal Investigator Email: md.pavlov@mail.bg
Contact Person Name: Dimitar Pavlov
Contact Person Email: md.pavlov@mail.bg

Site Name: Acibadem City Clinic Tokuda University Hospital EAD
Department Name: Gastroenterology clinic
Principal Investigator Name: Petko Karagyozov
Principal Investigator Email: petko.karagyozov@gmail.com
Contact Person Name: Petko Karagyozov
Contact Person Email: petko.karagyozov@gmail.com

Site Name: University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name: Gastroenterology clinic
Principal Investigator Name: Desislav Stanchev
Principal Investigator Email: dessislavs@gmail.com
Contact Person Name: Desislav Stanchev
Contact Person Email: dessislavs@gmail.com

Site Name: University Hospital Queen Govanna
Department Name: Gastroenterology clinic
Principal Investigator Name: Plamen Penchev
Principal Investigator Email: penchev.dr@gmail.com
Contact Person Name: Plamen Penchev
Contact Person Email: penchev.dr@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date: 21-06-2024
Latest Decision Or Authorization Date: 03-07-2024
Processing Time Days: 12
Number Of Sites: 12
Number Of Participants: 6

Sites

Site Name: PreventaMed s.r.o.
Department Name: Ambulantní ordinace interního lékařství
Principal Investigator Name: Jiří Pumprla
Principal Investigator Email: pumprla@vilazdravi.cz
Contact Person Name: Jiří Pumprla
Contact Person Email: pumprla@vilazdravi.cz

Site Name: Fakultni Nemocnice Kralovske Vinohrady
Department Name: IBD centrum - Chirurgická klinika
Principal Investigator Name: Zuzana Šerclová
Principal Investigator Email: sercl@seznam.cz
Contact Person Name: Zuzana Šerclová
Contact Person Email: sercl@seznam.cz

Site Name: SurGal Clinic s.r.o.
Department Name: Endoskopické centrum
Principal Investigator Name: Jan Ulbrych
Principal Investigator Email: ulbrych.jan@surgalclinic.cz
Contact Person Name: Jan Ulbrych
Contact Person Email: ulbrych.jan@surgalclinic.cz

Site Name: Nemocnice Ceske Budejovice a.s.
Department Name: Gastroenterologické oddělení
Principal Investigator Name: Martin Bortlík
Principal Investigator Email: mbortlik@seznam.cz
Contact Person Name: Martin Bortlík
Contact Person Email: mbortlik@seznam.cz

Site Name: Vojenska Nemocnice Brno
Department Name: Interní oddělení
Principal Investigator Name: David Štěpek
Principal Investigator Email: dstepek@vnbrno.cz
Contact Person Name: David Štěpek
Contact Person Email: dstepek@vnbrno.cz

Site Name: Fakultni Nemocnice Brno
Department Name: Interní gastroenterologická klinika, Endoskopické centrum
Principal Investigator Name: Štefan Konečný
Principal Investigator Email: konecny.stefan@fnbrno.cz
Contact Person Name: Štefan Konečný
Contact Person Email: konecny.stefan@fnbrno.cz

Site Name: Gastromedic s.r.o.
Principal Investigator Name: Václav Leksa
Principal Investigator Email: vaclav.leksa@seznam.cz
Contact Person Name: Václav Leksa
Contact Person Email: vaclav.leksa@seznam.cz

Site Name: Hepato-Gastroenterologie HK s.r.o.
Principal Investigator Name: Tomáš Vaňásek
Principal Investigator Email: coordinator3@hepato-gastro.com
Contact Person Name: Tomáš Vaňásek
Contact Person Email: coordinator3@hepato-gastro.com

Site Name: Fakultni Nemocnice Ostrava
Department Name: Oddělení gastroenterology a hepatologie a pankreatologie
Principal Investigator Name: Pavel Svoboda
Principal Investigator Email: fno@fno.cz
Contact Person Name: Pavel Svoboda
Contact Person Email: fno@fno.cz

Site Name: EndoArt s.r.o.
Department Name: Gastroenterologie
Principal Investigator Name: Radka Košková
Principal Investigator Email: mudr.koskova@seznam.cz
Contact Person Name: Radka Košková
Contact Person Email: mudr.koskova@seznam.cz

Site Name: Axon Clinical s.r.o.
Principal Investigator Name: Jan Matouš
Principal Investigator Email: info@axon-clinical.com
Contact Person Name: Jan Matouš
Contact Person Email: info@axon-clinical.com

Site Name: Krajská zdravotní a.s. - Masarykova nemocnice Ústí nad Labem, o.z.
Department Name: Gastroenterologické oddělení
Principal Investigator Name: Jiří Stehlík
Principal Investigator Email: jiri.stehlik@kzcr.eu
Contact Person Name: Jiří Stehlík
Contact Person Email: jiri.stehlik@kzcr.eu

Norway

Earliest CTIS Part Ii Submission Date: 25-06-2024
Latest Decision Or Authorization Date: 01-07-2024
Processing Time Days: 6
Number Of Sites: 4
Number Of Participants: 6

Sites

Site Name: Sykehuset Innlandet HF
Department Name: Department of Internal Medicine
Principal Investigator Name: Oistein Hovde
Principal Investigator Email: Oistein.Hovde@sykehuset-innlandet.no
Contact Person Name: Oistein Hovde
Contact Person Email: Oistein.Hovde@sykehuset-innlandet.no

Site Name: Akershus University Hospital
Department Name: Gastroenterology
Principal Investigator Name: Stephan Brackmann
Principal Investigator Email: Stephan.Andreas.Brackmann@ahus.no
Contact Person Name: Stephan Brackmann
Contact Person Email: Stephan.Andreas.Brackmann@ahus.no

Site Name: Vestre Viken HF
Department Name: Gastroenterology
Principal Investigator Name: Stine Astrup Hvattum
Principal Investigator Email: sthvat@vestreviken.no
Contact Person Name: Stine Astrup Hvattum
Contact Person Email: sthvat@vestreviken.no

Site Name: Oslo University Hospital HF
Department Name: Gastorenterology
Principal Investigator Name: Vendel Kristensen
Principal Investigator Email: venkri@ous-hf.no
Contact Person Name: Vendel Kristensen
Contact Person Email: venkri@ous-hf.no

Sponsor

Primary sponsor

Full Name: Takeda Development Center Americas Inc.
Organisation Type: Pharmaceutical company
Country Of Registered Address: United States

Contract research organisations

Name: Icon Clinical Research Limited
Responsibilities: study support; listed sponsor duties include codes 1 and 5 (as provided in dataset)

Name: PRA Hellas CRO A.E.
Responsibilities: Study start-up, contract negotiation and monitoring activities in Greece

Name: WCG Clinical Inc.
Responsibilities: patient recruitment

Third parties

{"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"patient recruitment","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"patient recruitment","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG Collection/MACE adjudication","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"Study start-up, contract negotiation and monitoring activities in Greece","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Scout Clinical","duties_or_roles":"patient recruitment/stipend","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Imaging Services","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"DMC","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"patient recruitment","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: ZASOCITINIB
Active Substance: ZASOCITINIB
Modality: Small molecule
Routes Of Administration: ORAL
Route: Oral
Authorisation Status: Investigational
Starting Dose: 30 mg
Dose Levels: 30 mg; 50 mg; 75 mg
Frequency: QD
Maximum Dose: 75 mg
Dose Escalation Increase: Initial 30 mg, following doses 50 mg and 75 mg

Investigational Product Name: TAK-279 placebo (same excipient as TAK-279)
Modality: Other

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