Clinical trial • Phase II • Gastroenterology

ZASOCITINIB for Ulcerative colitis | Crohn's disease

Phase II trial of ZASOCITINIB for Ulcerative colitis | Crohn's disease. open-label. 83 participants.

Overview

Trial Therapeutic Area: Gastroenterology
Trial Disease: Ulcerative colitis | Crohn's disease
Trial Stage: Phase II
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 24-01-2025
First CTIS Authorization Date: 07-05-2025

Trial design

open-label Phase II trial in Romania, Slovakia, Netherlands and others.

Open Label: Yes
Target Sample Size: 83
Trial Duration For Participant: 784

Eligibility

Recruits 83 Vulnerable population selection is indicated. Informed consent must be provided in writing via a signed and dated ICF prior to any trial procedures and the investigator must judge that the participant is willing and able to understand and comply. No procedures for assent or parental consent are described in the documentation (study enrolls adults who completed parent trials)..

Pregnancy Exclusion: 3. Are pregnant, nursing, or planning pregnancy while in the OLE trial or within 10 days of the trial intervention after the last dose of the trial intervention.
Vulnerable Population: Vulnerable population selection is indicated. Informed consent must be provided in writing via a signed and dated ICF prior to any trial procedures and the investigator must judge that the participant is willing and able to understand and comply. No procedures for assent or parental consent are described in the documentation (study enrolls adults who completed parent trials).

Inclusion criteria

{"criterion_text":"- 1. The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator. The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form [ICF]) and any required privacy authorization prior to the initiation of any trial procedures.\n- 2. Completion of Week 52 in the parent phase 2 CD and UC trials with valid eDiary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001). If eDiary data is not available at Week 52, prior scores may be used upon consultation with the medical monitor.\n- 3. Clinical or symptomatic responder at parent trial Week 52 as defined below: a) TAK-279-CD-2001: Clinical response in PRO2 at parent trial Week 52, assessed as ≥30% decrease in average daily very soft or liquid stools and/or ≥decrease in average AP from parent trial baseline. b) TAK-279-UC-2001: Symptomatic response at parent trial Week 52, assessed as a reduction in pmMS of ≥1 points and ≥30% from parent trial baseline; and a decrease from parent trial baseline in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point.\n- 4. Participants are nonpregnant, nonlactating or of nonchildbearing potential. For individuals of reproductive potential, if sexually active, agree to comply with the contraceptive requirements for the duration of the trial and 10 days after the last dose of the trial intervention. The following birth control requirements must be met: a) Effective contraception for male (sex-assigned at birth) participants (male condom) is required from the signing of informed consent throughout the duration of the trial and for 10 days after the last dose of the trial intervention. b) Female (sex-assigned at birth) participants must be surgically sterile or be of nonchildbearing potential with confirmation of postmenopausal status (ie, follicle-stimulating hormone [FSH] 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 trial and for 10 days after the last dose."}

Exclusion criteria

{"criterion_text":"- 1. Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.\n- 2. Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE\n- 3. Are pregnant, nursing, or planning pregnancy while in the OLE trial or within 10 days of the trial intervention after the last dose of the trial intervention.\n- 4. Participant has inadequate renal or hepatic function before enrollment based on the following parameters: a) Total bilirubin (unconjugated and/or conjugated) ≥1.5 × upper limit normal (ULN) unless the participant has known Gilbert’s syndrome that can explain the elevation of bilirubin, or b) Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × ULN, or c) Creatinine >1.5 × ULN. d) Estimated creatinine clearance <45 mL/min based on the Cockcroft-Gault calculation. e) Participant with elevated lipase and/or amylase >3 × ULN. Participants with elevated lipase and/or amylase >2 × ULN will require further workup such as radiological imaging and physical examination to rule out a diagnosis of acute pancreatitis. Once a diagnosis of acute pancreatitis has been completely ruled out, then the participant can be included in the trial. f) Participants with a history of chronic pancreatitis or recent acute pancreatitis (<60 days/ not fully resolved).\n- 5. Participant with any of the following laboratory values at or prior to enrollment: 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 f) Triglyceride level ≥750 mg/dL (≥8.5 mmol/L) g) Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial. h) Creatine phosphokinase (CPK) > ULN. CPK may be repeated once; if repeat value is CTCAE Grade 1 or lower (or ≤2.5 × ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for modulating factors including concomitant medications or vigorous exercise that may affect CPK levels.\n- 6. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48."}

Endpoints

Primary endpoints

{"endpoint_text":"- 1. Incidence of treatment-emergent adverse events (TEAEs) by indication.","definition_or_measurement_approach":"Incidence (count/proportion) of treatment-emergent adverse events (TEAEs) categorized by disease indication."}
{"endpoint_text":"- 2. Clinically significant changes in vital signs, clinical laboratory parameters, electrocardiogram by indication.","definition_or_measurement_approach":"Assessment of clinically significant changes from baseline in vital signs, clinical laboratory parameters, and ECGs, reported by indication."}
{"endpoint_text":"- 3. Incidence of adverse events of special interest (AESIs) by indication.","definition_or_measurement_approach":"Incidence (count/proportion) of predefined adverse events of special interest (AESIs) categorized by indication."}

Secondary endpoints

{"endpoint_text":"- 1. Clinical remission by visit, assessed as proportion of participants achieving CD Activity Index (CDAI) <150.","definition_or_measurement_approach":"Proportion of participants with CDAI <150 at each visit."}
{"endpoint_text":"- 2. Clinical response by visit, assessed as proportion of participants achieving reduction of CDAI from baseline (defined as baseline in parent phase 2 CD trial) of >100.","definition_or_measurement_approach":"Proportion of participants with a decrease in CDAI >100 from baseline (baseline defined as parent phase 2 CD trial)."}
{"endpoint_text":"- 3. Endoscopic response at annual assessments at Week 48 and Week 108, assessed as proportion of participants achieving decrease in simplified endoscopic score for CD (SES-CD) >50% from baseline (defined as baseline in parent phase 2 CD trial) (or for participants with isolated ileal disease, SES-CD <4 or at least a 2-point from baseline read centrally).","definition_or_measurement_approach":"Proportion achieving >50% reduction in SES-CD vs baseline (or SES-CD <4 or ≥2-point reduction for isolated ileal disease), assessed at Week 48 and Week 108 (central read)."}
{"endpoint_text":"- 4. Endoscopic remission at annual assessments at Week 48 and Week 108, assessed as proportion of participants achieving SES-CD <4 or <2 for ileal disease.","definition_or_measurement_approach":"Proportion achieving SES-CD <4 (or <2 for ileal disease) at Week 48 and Week 108."}
{"endpoint_text":"- 5. Clinical remission in two patient-reported outcome items (PRO2) of the CDAI by visit, assessed as proportion of participants with average daily liquid or very soft stool frequency (SF) score ≤2.8 and not worse than baseline (defined as baseline in parent phase 2 CD trial) and average daily abdominal pain (AP) score ≤1 and not worse than baseline (defined as baseline in parent phase 2 CD trial).","definition_or_measurement_approach":"Proportion meeting PRO2 criteria: average daily SF ≤2.8 and average daily AP ≤1 and not worse than baseline, by visit."}
{"endpoint_text":"- 6. Clinical response in PRO2 by visit, assessed as proportion of participants with ≥30% decrease in average daily very soft or liquid stools and/ or ≥30% decrease in average AP from baseline (defined as baseline in parent phase 2 CD trial).","definition_or_measurement_approach":"Proportion with ≥30% decrease in average daily very soft/liquid stool frequency and/or ≥30% decrease in average AP from baseline by visit."}
{"endpoint_text":"- 1. Clinical remission at annual assessments (Week 48 and Week 108), assessed as proportion of participants achieving a modified Mayo Score (mMS) of ≤2 with SF subscore of ≤1, rectal bleeding subscore of 0, and centrally read endoscopic subscore of ≤1 (score of 1 modified to exclude friability).","definition_or_measurement_approach":"Proportion achieving mMS ≤2 with SF ≤1, rectal bleeding =0 and centrally read endoscopic subscore ≤1 at Week 48 and Week 108."}
{"endpoint_text":"- 2. Clinical Response at annual assessments (Week 48 and Week 108), assessed as the proportion of participants achieving a reduction from baseline (defined as baseline in parent phase 2 UC trial) in mMS of ≥2 points and ≥30% from baseline (defined as baseline in parent phase 2 UC trial) and a decrease from baseline in the rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point.","definition_or_measurement_approach":"Proportion with mMS reduction ≥2 points and ≥30% vs baseline and rectal bleeding subscore reduction ≥1 point or absolute ≤1 at annual assessments."}
{"endpoint_text":"- 3. Symptomatic remission by visit, assessed as the proportion of participants achieving a rectal bleeding subscore of 0 and SF subscore of Mayo score of ≤1.","definition_or_measurement_approach":"Proportion with rectal bleeding subscore =0 and SF subscore ≤1 by visit."}
{"endpoint_text":"- 4. Endoscopic improvement at annual assessments (Week 48 and Week 108), assessed as the proportion of participants achieving a modified Mayo endoscopic subscore of ≤1 (score of 1 to exclude friability).","definition_or_measurement_approach":"Proportion achieving modified Mayo endoscopic subscore ≤1 at annual assessments."}
{"endpoint_text":"- 5. Endoscopic remission at annual assessments (Week 48 and Week 108), assessed as the proportion of participants achieving a modified Mayo endoscopic subscore of 0.","definition_or_measurement_approach":"Proportion achieving modified Mayo endoscopic subscore =0 at annual assessments."}
{"endpoint_text":"- 1. Proportion of participants with no bowel urgency by visit as measured by the bowel urgency eDiary item.","definition_or_measurement_approach":"Proportion reporting no bowel urgency per eDiary item at each visit."}
{"endpoint_text":"- 2. Proportion of participants with no AP by visit as measured by the AP eDiary item.","definition_or_measurement_approach":"Proportion reporting no abdominal pain per eDiary AP item at each visit."}
{"endpoint_text":"- 3. Change from baseline (defined as baseline in parent phase 2 CD or UC trials) in fatigue as measured by the FACIT-Fatigue score by visit.","definition_or_measurement_approach":"Change from baseline in FACIT-Fatigue total score, by visit."}
{"endpoint_text":"- 4. Disease-specific HRQoL as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) total score by visit, assessed as the proportion of participants with total score ≥170.","definition_or_measurement_approach":"Proportion with IBDQ total score ≥170 by visit."}
{"endpoint_text":"- 5. Change from baseline (defined as baseline in parent phase 2 CD or UC trials) in disease‑specific HRQoL by visit as measured by the IBDQ total score.","definition_or_measurement_approach":"Change from baseline in IBDQ total score by visit."}

Recruitment

Digital Remote Recruitment: Yes
Planned Sample Size: 83
Recruitment Window Months: 50
Consent Approach: Written informed consent is required prior to any trial procedures: participants must provide a signed and dated ICF (in writing). The investigator must assess willingness and capacity to understand and comply. Subject information/ICF documents are provided in multiple languages and site-specific ICFs are available (examples in repository include English, Romanian, French, Dutch, Hungarian, Polish, Slovak, Greek, Italian and others). No assent/parental consent processes are described (study population are adults completing parent trials).

Methods

Patient transition/targeted re-contact of participants from the parent Phase 2 CD and UC trials via Patient Transition Letter and Patient Transition Email (documents: K2_Patient Transition Letter / K2_Patient Transition Email)
Appointment reminder cards for participants (documents: K2_Appointment Reminder Card)
Recruitment via contracted patient recruitment vendors (Clinical Trial Media Inc.; Scout Clinical; Scout-related materials such as Scout Study Brochure, Scout Email Communication and Reloadable ScoutPass mailers are listed in documents and third-party duties)
Site-based recruitment and referral through participating investigational sites and patient organisations (e.g., Amsterdam UMC listed as a patient organisation site)
Direct site outreach and standard informed-consent recruitment processes described in K1_Recruit-ICF and K1_Recruitment procedure documents

Geography

Total Number Of Sites: 85
Total Number Of Participants: 104

Romania

Earliest CTIS Part Ii Submission Date: 05-05-2025
Latest Decision Or Authorization Date: 19-12-2025
Processing Time Days: 228
Number Of Sites: 7
Number Of Participants: 5

Sites

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: Memorial Healthcare International S.R.L.
Department Name: Departament Clinic de Gastroenterologie
Principal Investigator Name: Ion Eugeniu Craciun
Principal Investigator Email: secretariat@memorial.ro
Contact Person Name: Ion Eugeniu Craciun
Contact Person Email: secretariat@memorial.ro

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: 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

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: 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

Slovakia

Earliest CTIS Part Ii Submission Date: 17-04-2025
Latest Decision Or Authorization Date: 15-12-2025
Processing Time Days: 242
Number Of Sites: 5
Number Of Participants: 5

Sites

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

Site Name: Accout Center s.r.o.
Department Name: Gastroenterologická ambulancia
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: F D Roosevelt University General Hospital Of Banska Bystrica
Department Name: Gastroenterologická ambulancia
Principal Investigator Name: Jozef Baláž
Principal Investigator Email: balaz78@gmail.com
Contact Person Name: Jozef Baláž
Contact Person Email: balaz78@gmail.com

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

Netherlands

Earliest CTIS Part Ii Submission Date: 17-04-2025
Latest Decision Or Authorization Date: 17-12-2025
Processing Time Days: 244
Number Of Sites: 3
Number Of Participants: 2

Sites

Site Name: Stichting 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

France

Earliest CTIS Part Ii Submission Date: 02-05-2025
Latest Decision Or Authorization Date: 12-01-2026
Processing Time Days: 255
Number Of Sites: 5
Number Of Participants: 5

Sites

Site Name: Centre Hospitalier Universitaire De Nice
Department Name: Gastro-enterology
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: Clinical investigation unit
Principal Investigator Name: Benedicte Caron
Principal Investigator Email: b.caron@chru-nancy.fr
Contact Person Name: Benedicte Caron
Contact Person Email: b.caron@chru-nancy.fr

Site Name: Centre Hospitalier Universitaire De Saint Etienne
Department Name: Gastroenterology
Principal Investigator Name: Mathilde Barrau
Principal Investigator Email: mathilde.barrau@chu-st-etienne.fr
Contact Person Name: Mathilde Barrau
Contact Person Email: mathilde.barrau@chu-st-etienne.fr

Site Name: Centre Hospitalier Regional Universitaire De Tours
Department Name: Hepato-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: 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

Hungary

Earliest CTIS Part Ii Submission Date: 21-03-2025
Latest Decision Or Authorization Date: 03-02-2026
Processing Time Days: 319
Number Of Sites: 5
Number Of Participants: 6

Sites

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

Site Name: Pannonia Maganorvosi Centrum Kft.
Principal Investigator Name: Róbert Schnábel
Principal Investigator Email: info@pmcmedical.hu
Contact Person Name: Róbert Schnábel
Contact Person Email: info@pmcmedical.hu

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

Site Name: Javorszky Oedoen Korhaz
Department Name: Gasztroenterológia
Principal Investigator Name: Szalóki Tibor
Principal Investigator Email: szalokitdr@javorszky.hu
Contact Person Name: Szalóki Tibor
Contact Person Email: szalokitdr@javorszky.hu

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

Belgium

Earliest CTIS Part Ii Submission Date: 16-04-2025
Latest Decision Or Authorization Date: 28-01-2026
Processing Time Days: 287
Number Of Sites: 4
Number Of Participants: 3

Sites

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: Hopital Erasme
Department Name: Gastroenterology
Principal Investigator Name: Denis Franchimont
Principal Investigator Email: denis.franchimont@hubruxelles.be
Contact Person Name: Denis Franchimont
Contact Person Email: denis.franchimont@hubruxelles.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

Greece

Earliest CTIS Part Ii Submission Date: 20-02-2025
Latest Decision Or Authorization Date: 22-12-2025
Processing Time Days: 305
Number Of Sites: 6
Number Of Participants: 6

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: 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

Site Name: Alexandra Hospital
Department Name: Hepato-Gastroenterology Department
Principal Investigator Name: Evanthia Zampeli
Principal Investigator Email: gastro.alexandra@gmail.com
Contact Person Name: Evanthia Zampeli
Contact Person Email: gastro.alexandra@gmail.com

Site Name: Thoracic General Hospital Of Athens I Sotiria
Department Name: GI Unit – 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: ikoutroub2@gmail.com
Contact Person Name: Ioannis Koutroubakis
Contact Person Email: ikoutroub2@gmail.com

Germany

Earliest CTIS Part Ii Submission Date: 16-04-2025
Latest Decision Or Authorization Date: 15-01-2026
Processing Time Days: 274
Number Of Sites: 7
Number Of Participants: 10

Sites

Site Name: Universitaetsklinikum Ulm AöR
Department Name: Center of Internal Medicine, Internal Medicine I
Principal Investigator Name: Jochen Gerhard Klaus
Principal Investigator Email: CED-Studienambulanz.IM1@uniklinik-ulm.de
Contact Person Name: Jochen Gerhard Klaus
Contact Person Email: CED-Studienambulanz.IM1@uniklinik-ulm.de

Site Name: Heidelberg University
Department Name: II. Medizinische Klinik
Principal Investigator Name: Wolfgang Reindl
Principal Investigator Email: mcc-studienzentrale@medma.uni-heidelberg.de
Contact Person Name: Wolfgang Reindl
Contact Person Email: mcc-studienzentrale@medma.uni-heidelberg.de

Site Name: Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name: Agaplesion Markus Krankenhaus, Medizinische Klinik I
Principal Investigator Name: Axel Dignass
Principal Investigator Email: Axel.dignass@agaplesion.de
Contact Person Name: Axel Dignass
Contact Person Email: Axel.dignass@agaplesion.de

Site Name: Goethe University Frankfurt
Department Name: Medizinische Klinik I
Principal Investigator Name: Irina Reindl
Principal Investigator Email: mcc-studienzentrale@medma.uni-heidelberg.de
Contact Person Name: Irina Reindl
Contact Person Email: mcc-studienzentrale@medma.uni-heidelberg.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: studienabteilung@st-marienkrankenhaus.de
Contact Person Name: Tanja Kuehbacher
Contact Person Email: studienabteilung@st-marienkrankenhaus.de

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

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

Italy

Earliest CTIS Part Ii Submission Date: 14-04-2025
Latest Decision Or Authorization Date: 04-02-2026
Processing Time Days: 296
Number Of Sites: 7
Number Of Participants: 9

Sites

Site Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name: Internal Medicine and Gastroenterology Unit - Largo Agostino Gemelli 8, Rome, 00168
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: 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

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: 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: Humanitas Mirasole S.p.A.
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 - Via Commenda 19, Milano, 20122
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: Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name: Chronic inflammatory bowel disease unit- Via Giuseppe Massarenti 9, Bologna, 40138
Principal Investigator Name: Fernando Rizzello
Principal Investigator Email: fernando.rizzelo@unibo.it
Contact Person Name: Fernando Rizzello
Contact Person Email: fernando.rizzelo@unibo.it

Norway

Earliest CTIS Part Ii Submission Date: 07-05-2025
Latest Decision Or Authorization Date: 16-12-2025
Processing Time Days: 223
Number Of Sites: 2
Number Of Participants: 4

Sites

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

Denmark

Earliest CTIS Part Ii Submission Date: 16-04-2025
Latest Decision Or Authorization Date: 17-12-2025
Processing Time Days: 245
Number Of Sites: 6
Number Of Participants: 8

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: 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: Region Hovedstaden
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: 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

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: 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

Czechia

Earliest CTIS Part Ii Submission Date: 16-04-2025
Latest Decision Or Authorization Date: 02-02-2026
Processing Time Days: 292
Number Of Sites: 12
Number Of Participants: 4

Sites

Site Name: Fakultni Nemocnice Ostrava
Department Name: Oddělení gastroenterologie 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: 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: 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: Krajska zdravotni a.s.
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

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: Axon Clinical s.r.o.
Department Name: Gastroenterologie
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: Endohope klinika s.r.o.
Principal Investigator Name: Lukáš Bajer
Principal Investigator Email: bajer@endohope.cz
Contact Person Name: Lukáš Bajer
Contact Person Email: bajer@endohope.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: Fakultni Nemocnice Kralovske Vinohrady
Department Name: IBD centrum - Chirurgická klinika
Principal Investigator Name: Zuzana Šerclová
Principal Investigator Email: serclovaz@fnkv.cz
Contact Person Name: Zuzana Šerclová
Contact Person Email: serclovaz@fnkv.cz

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

Poland

Earliest CTIS Part Ii Submission Date: 17-04-2025
Latest Decision Or Authorization Date: 22-12-2025
Processing Time Days: 249
Number Of Sites: 16
Number Of Participants: 37

Sites

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: Medrise Sp. z o.o.
Principal Investigator Name: Wit Danilkiewicz
Principal Investigator Email: wit.danilkiewicz@medrise.pl
Contact Person Name: Wit Danilkiewicz
Contact Person Email: wit.danilkiewicz@medrise.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

Site Name: Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Department Name: Centrum Badan Klinicznych Osrodek Badan 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: 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: Amicare Sp. z o.o. S.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: Centrum Medyczne Medyk Sp. z o.o.
Department Name: Szpital Centrum Medycznego Medyk
Principal Investigator Name: Rafał Filip
Principal Investigator Email: badaniakliniczne.rejtana@medyk.rzeszow.pl
Contact Person Name: Rafał Filip
Contact Person Email: badaniakliniczne.rejtana@medyk.rzeszow.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: 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: Etg Zamosc 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: Manermed Sp. z o.o.
Department Name: Centrum Medyczne "Medis"
Principal Investigator Name: Maria Kłopocka
Principal Investigator Email: clinicaltrials@cm-medis.pl
Contact Person Name: Maria Kłopocka
Contact Person Email: clinicaltrials@cm-medis.pl

Site Name: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name: Oddzial Kliniczny Gastroenterologii Ogolnej 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: Torunskie 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: 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: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name: Klinika Gastroenterologii i Chorób Wewnętrznych
Principal Investigator Name: Grażyna Rydzewska-Wyszkowska
Principal Investigator Email: gastroenterologia@cskmswia.gov.pl
Contact Person Name: Grażyna Rydzewska-Wyszkowska
Contact Person Email: gastroenterologia@cskmswia.gov.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

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: CRO

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

Third parties

{"country":"United States","full_name":"Eurofins Viracor Biopharma Services LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement/Stipend","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"DMC","organisation_type":"Non-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":"Azenta US Inc.","duties_or_roles":"Long Term Storage Biomarkers","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
{"country":"Netherlands","full_name":"Alimentiv B.V.","duties_or_roles":"Shipping kits/supplies to site in EU for Imaging","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
{"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
{"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
{"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Imaging Services","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 Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name: ZASOCITINIB
Active Substance: ZASOCITINIB
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Starting Dose: Once daily 2 capsules
Frequency: Once daily

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