Clinical trial • Phase III • Gastroenterology
Etrasimod arginine for Ulcerative colitis
Phase III trial of Etrasimod arginine for Ulcerative colitis. open-label, none/not specified-controlled. 587 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 30-08-2024
- First CTIS Authorization Date
- 24-09-2024
Trial design
open-label, none/not specified-controlled Phase III trial in Belgium, Estonia, France and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 587
- Trial Duration For Participant
- 1820
Eligibility
Recruits 587 paediatric patients.
- Pregnancy Exclusion
- Eligible women of childbearing potential must fulfill the following on Week 0/Day 1: a. Have a negative urine beta-human chorionic gonadotropin (β-hCG) pregnancy test b. Not breastfeeding
- Vulnerable Population
- The protocol permits assent and consent processes for minors: 'Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a subject < 18 years of age or as required per local regulations who has assented to participate in the study) ... Enrollment of subjects < 18 years should be conducted only if acceptable according to local laws and regulations.' This indicates minors may assent and require parent/legal guardian consent; enrollment of subjects under 18 is allowed only where locally permitted and documented with age-appropriate consent/assent forms.
Inclusion criteria
- {"criterion_text":"- 1. Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 and 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria: a. Subjects previously enrolled in Study APD334-301 or APD334-210 must have either: I. Completed the Week 52 visit or II. Completed the Week 12 visit and whose UC condition in the opinion of the Investigator has not improved or has worsened, compared with baseline (Week 0/Day 1 in the parent study), provided their Endoscopic Score (ES) is ≥ 2 and they meet one of the following entry criteria: - RB sub-score ≥ 2 at 2 timepoints at least 7 days and no more than 14 days apart. - RB + SF sub-scores ≥ 4 at 2 timepoints at least 7 days and no more than 14 days apart. - RB sub-score ≥ 2 or RB + SF sub-scores ≥ 4 (in any order) at 2 timepoints at least 7 days and no more than 14 days apart. Note: For subjects discontinuing prior to Week 52, an endoscopic evaluation is required to confirm eligibility for the OLE. An endoscopy should be performed upon the appearance of UC symptoms but no more than 14 days after the second timepoint for entry criteria above. A proctosigmoidoscopy does not need to be repeated if performed within the last 4 weeks. b. Subjects previously enrolled in Study APD334-302 must have completed the Week 12 visit."}
- {"criterion_text":"- 2. Eligible women of childbearing potential must fulfill the following on Week 0/Day 1: a. Have a negative urine beta-human chorionic gonadotropin (β-hCG) pregnancy test b. Not breastfeeding"}
- {"criterion_text":"- 3. Females must meet either a or b of the following criteria and males must meet criterion c to qualify for the study: a. A female who is not of childbearing potential must meet 1 of the following: - Postmenopausal, defined as no menses for 12 months without an alternative medical cause - Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy b. A nonpregnant female of childbearing potential must agree to using a highly effective contraception method during treatment and for 30 days following treatment that can achieve a failure rate of less than 1% per year when used consistently and correctly. The following are considered highly effective birth control methods: - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal - Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted - Intrauterine device (IUD) - Intrauterine hormone-releasing system - Bilateral tubal occlusion - Vasectomized partner, provided that partner is the sole sexual partner of the female of childbearing potential trial subject and that the vasectomized partner has received medical assessment of the surgical success - Sexual abstinence (complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study treatments). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable c. A male subject with a pregnant or nonpregnant female of childbearing potential partner must agree to using condoms during treatment and for 30 days following treatment."}
- {"criterion_text":"- 4. Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a subject < 18 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of subjects < 18 years should be conducted only if acceptable according to local laws and regulations."}
Exclusion criteria
- {"criterion_text":"- 1. The Investigator considers the subject to be unsuitable for any reason to participate in the OLE study."}
- {"criterion_text":"- 2. Experienced an adverse event (AE) that led to discontinuation (except when such an event is related to worsening of disease) from parent study."}
- {"criterion_text":"- 3. Week 0/Day 1 pre-dose sitting vital sign assessment: heart rate (HR) < 50 bpm OR systolic BP < 90 mm Hg OR diastolic BP < 55 mm Hg."}
- {"criterion_text":"- 4. Week 0/Day 1 pre-dose 12-lead electrocardiogram (ECG) in the supine position showing a second or third-degree AV block, periods of asystole > 3 seconds, PR interval > 200 ms, or Fridericia’s corrected QT interval (QTcF) ≥ 450 ms (men) or QTcF ≥ 470 ms (women)."}
- {"criterion_text":"- 5. Subjects requiring colectomy during the parent study."}
- {"criterion_text":"- 6. Subjects requiring treatment with prohibited concomitant medications as defined in the parent study."}
- {"criterion_text":"- 7. (Any other investigator-determined reasons as listed) - implicit in principal exclusion statements present."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence and severity of laboratory abnormalities, and change from treatment baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of vital sign abnormalities and changes from treatment baseline","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- The proportion of subjects achieving clinical remission at Weeks 52 and 104","definition_or_measurement_approach":""}
- {"endpoint_text":"- The proportion of subjects achieving clinical remission at Weeks 52 and 104, among subjects achieving clinical remission at study entry","definition_or_measurement_approach":""}
- {"endpoint_text":"- The proportion of subjects achieving clinical response at Weeks 52 and 104","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline in the Total Mayo Score (TMS) at Weeks 52 and 104","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline in Partial Mayo Score (PMS) at each of the following weeks: Weeks 52, 104, 156, 208, and 260","definition_or_measurement_approach":""}
- {"endpoint_text":"- The proportion of subjects achieving endoscopic improvement at Weeks 52 and 104","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 587
- Recruitment Window Months
- 111
- Consent Approach
- Written informed consent or assent is required. 'Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a subject < 18 years of age or as required per local regulations who has assented to participate in the study) ... Enrollment of subjects < 18 years should be conducted only if acceptable according to local laws and regulations.' Age-specific parental/guardian information and consent forms are included in the documentation (parental ICDs and adolescent-specific ICDs are provided where applicable); subject information and consent forms are available in multiple languages as indicated in the submission (country-specific ICDs listed in the public documents).
Geography
- Total Number Of Sites
- 63
- Total Number Of Participants
- 298
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 26-09-2024
- Processing Time Days
- 9
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Algemeen Ziekenhuis Delta
- Principal Investigator Name
- Filip Baert
- Principal Investigator Email
- filip.baert@azdelta.be
- Contact Person Name
- Filip Baert
- Contact Person Email
- filip.baert@azdelta.be
- Site Name
- AZ Sint-Lucas & Volkskliniek
- Principal Investigator Name
- Harald Peeters
- Principal Investigator Email
- harald.peeters@azstlucas.be
- Contact Person Name
- Harald Peeters
- Contact Person Email
- harald.peeters@azstlucas.be
Estonia
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 27-09-2024
- Processing Time Days
- 10
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- North Estonia Medical Centre Foundation
- Department Name
- Gastroenterology
- Principal Investigator Name
- Julia Borissova
- Principal Investigator Email
- julia.borissova@regionaalhaigla.ee
- Contact Person Name
- Julia Borissova
- Contact Person Email
- julia.borissova@regionaalhaigla.ee
- Site Name
- Laane-Tallinna Keskhaigla AS
- Department Name
- Gastroenterology
- Principal Investigator Name
- Anu Maelt
- Principal Investigator Email
- amaelt@gmail.com
- Contact Person Name
- Anu Maelt
- Contact Person Email
- amaelt@gmail.com
- Site Name
- Innomedica OÜ
- Principal Investigator Name
- Jaak Talli
- Principal Investigator Email
- jaak.talli@innomedica.ee
- Contact Person Name
- Jaak Talli
- Contact Person Email
- jaak.talli@innomedica.ee
France
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 25-09-2024
- Processing Time Days
- 8
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service Hépato-Gastro-Entérologie
- Principal Investigator Name
- Caroline Trang
- Principal Investigator Email
- caroline.trang@chu-nantes.fr
- Contact Person Name
- Caroline Trang
- Contact Person Email
- caroline.trang@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service de Gastro-Entérologie et Nutrition
- Principal Investigator Name
- Xavier Hebuterne
- Principal Investigator Email
- hebuterne.x@chu-nice.fr
- Contact Person Name
- Xavier Hebuterne
- Contact Person Email
- hebuterne.x@chu-nice.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 08-10-2024
- Processing Time Days
- 21
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Praxis Dr. Jorgensen
- Department Name
- Gastoenterologische Gemeinschaftspraxis Remscheid
- Principal Investigator Name
- Eric Norgaard Jorgensen
- Principal Investigator Email
- ericjoergensen@me.com
- Contact Person Name
- Eric Norgaard Jorgensen
- Contact Person Email
- ericjoergensen@me.com
- Site Name
- Krankenhaus Waldfriede e.V.
- Department Name
- Dr. med Zacharias A. R.Sherif/ Innere Medizin
- Principal Investigator Name
- Carsten Büning
- Principal Investigator Email
- c.buening@waldfriede.de
- Contact Person Name
- Carsten Büning
- Contact Person Email
- c.buening@waldfriede.de
Lithuania
- Earliest CTIS Part Ii Submission Date
- 31-10-2024
- Latest Decision Or Authorization Date
- 20-11-2024
- Processing Time Days
- 20
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Principal Investigator Name
- Ieva Stundiene
- Principal Investigator Email
- ieva.stundiene@santa.lt
- Contact Person Name
- Ieva Stundiene
- Contact Person Email
- ieva.stundiene@santa.lt
- Site Name
- Respublikine Panevezio ligonine VšĮ
- Principal Investigator Name
- Darius Kriukas
- Principal Investigator Email
- drkriukas@gmail.com
- Contact Person Name
- Darius Kriukas
- Contact Person Email
- drkriukas@gmail.com
- Site Name
- Inlita UAB
- Principal Investigator Name
- Regina Ivanauskiene
- Principal Investigator Email
- regina.ivanauskiene@inlita.lt
- Contact Person Name
- Regina Ivanauskiene
- Contact Person Email
- regina.ivanauskiene@inlita.lt
Portugal
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 27-09-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Serviço de Gastrenterologia
- Principal Investigator Name
- Francisco Abilio Da Silva Portela
- Principal Investigator Email
- fasportela@gmail.com
- Contact Person Name
- Francisco Abilio Da Silva Portela
- Contact Person Email
- fasportela@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 30-09-2024
- Processing Time Days
- 13
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Spitalul de Oncologie Monza
- Department Name
- Departamentul de Gastroenterologie
- Principal Investigator Name
- Ion Eugeniu Craciun
- Principal Investigator Email
- eugencraciun@yahoo.com
- Contact Person Name
- Ion Eugeniu Craciun
- Contact Person Email
- eugencraciun@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Sectia Clinica Medicina Interna III
- Principal Investigator Name
- Dan Lucian Dumitrascu
- Principal Investigator Email
- ddumitrascu@umfcluj.ro
- Contact Person Name
- Dan Lucian Dumitrascu
- Contact Person Email
- ddumitrascu@umfcluj.ro
- Site Name
- Delta Health Care S.R.L.
- Department Name
- Sectia Gastroenterologie
- Principal Investigator Name
- Camelia Chioncel
- Principal Investigator Email
- cameliachioncel@yahoo.com
- Contact Person Name
- Camelia Chioncel
- Contact Person Email
- cameliachioncel@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 24-09-2024
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Servicio de Digestivo
- Principal Investigator Name
- Rodrigo Jover Martinez
- Principal Investigator Email
- rodrigojover@gmail.com
- Contact Person Name
- Rodrigo Jover Martinez
- Contact Person Email
- rodrigojover@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 31-10-2024
- Latest Decision Or Authorization Date
- 04-11-2024
- Processing Time Days
- 4
- Number Of Sites
- 9
- Number Of Participants
- 30
Sites
- Site Name
- Azienda Ospedaliera Per L'Emergenza Cannizzaro
- Department Name
- U.O.D. of Gastroenterology
- Principal Investigator Name
- Maria Emanuela Distefano
- Principal Investigator Email
- mici@ospedale-cannizzaro.it
- Contact Person Name
- Maria Emanuela Distefano
- Contact Person Email
- mici@ospedale-cannizzaro.it
- Site Name
- University Magna Graecia Of Catanzaro
- Department Name
- U.O. Fisiopatologia Digestiva
- Principal Investigator Name
- Francesco Luzza
- Principal Investigator Email
- luzza@unicz.it
- Contact Person Name
- Francesco Luzza
- Contact Person Email
- luzza@unicz.it
- Site Name
- National Institute Of Gastroenterology Saverio De Bellis Research Hospital
- Department Name
- Reparto Gastroenterologia 1
- Principal Investigator Name
- Mauro Mastronardi
- Principal Investigator Email
- mauro21mastronardi@gmail.com
- Contact Person Name
- Mauro Mastronardi
- Contact Person Email
- mauro21mastronardi@gmail.com
- Site Name
- Careggi University Hospital
- Department Name
- Gastroenterologia
- Principal Investigator Name
- Francesca Rogai
- Principal Investigator Email
- frogai@hotmail.com
- Contact Person Name
- Francesca Rogai
- Contact Person Email
- frogai@hotmail.com
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- U.O Gastroenterologia
- Principal Investigator Name
- Antonio Colecchia
- Principal Investigator Email
- antonio.colecchia.cs@gmail.com
- Contact Person Name
- Antonio Colecchia
- Contact Person Email
- antonio.colecchia.cs@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C. Gastroenterologia
- 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
- UO di Gastroenterologia e Endoscopia Digestiva
- Principal Investigator Name
- Silvio Danese
- Principal Investigator Email
- ibd.trials@hsr.it
- Contact Person Name
- Silvio Danese
- Contact Person Email
- ibd.trials@hsr.it
- Site Name
- Azienda Sanitaria Locale Roma 2
- Department Name
- Gastroenterologia
- Principal Investigator Name
- Pica Roberta
- Principal Investigator Email
- roberta.pica@aslroma2.it
- Contact Person Name
- Pica Roberta
- Contact Person Email
- roberta.pica@aslroma2.it
- Site Name
- Azienda Socio Sanitaria Territoriale Rhodense
- Department Name
- UOC Gastroenterologia
- Principal Investigator Name
- Simone Saibeni
- Principal Investigator Email
- saibo@tiscali.it
- Contact Person Name
- Simone Saibeni
- Contact Person Email
- saibo@tiscali.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 24-09-2024
- Processing Time Days
- 7
- Number Of Sites
- 8
- Number Of Participants
- 33
Sites
- Site Name
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
- Department Name
- I. Belgyogyaszat
- Principal Investigator Name
- Roland Fejes
- Principal Investigator Email
- rfejes@mail.fmkorhaz.hu
- Contact Person Name
- Roland Fejes
- Contact Person Email
- rfejes@mail.fmkorhaz.hu
- Site Name
- Semmelweis University
- Department Name
- Belgyogyaszati es Hematologiai Klinika
- Principal Investigator Name
- Zsolt Tulassay
- Principal Investigator Email
- tulassay.zsolt@med.semmelweis-univ.hu
- Contact Person Name
- Zsolt Tulassay
- Contact Person Email
- tulassay.zsolt@med.semmelweis-univ.hu
- Site Name
- Gyoengyosi Bugat Pal Koerhaz
- Department Name
- Gasztroenterologia
- Principal Investigator Name
- Gábor Makai
- Principal Investigator Email
- gabor.makai.clinexpert@gmail.com
- Contact Person Name
- Gábor Makai
- Contact Person Email
- gabor.makai.clinexpert@gmail.com
- Site Name
- DRC Kft.
- Principal Investigator Name
- Laszlo Koranyi
- Principal Investigator Email
- laszlo.koranyi@drc.hu
- Contact Person Name
- Laszlo Koranyi
- Contact Person Email
- laszlo.koranyi@drc.hu
- Site Name
- Clinfan Kft.
- Principal Investigator Name
- Agnes Salamon
- Principal Investigator Email
- salamon.agnes@tmkorhaz.hu
- Contact Person Name
- Agnes Salamon
- Contact Person Email
- salamon.agnes@tmkorhaz.hu
- Site Name
- Bekes Varmegyei Koezponti Korhaz
- Department Name
- Belgyogyaszat-Gasztroenterologia-Hepatologia
- Principal Investigator Name
- Marta Varga
- Principal Investigator Email
- drvargamarta@gmail.com
- Contact Person Name
- Marta Varga
- Contact Person Email
- drvargamarta@gmail.com
- Site Name
- Pannonia Maganorvosi Centrum Kft.
- Principal Investigator Name
- Robert Schnabel
- Principal Investigator Email
- schnabelrobert@hotmail.com
- Contact Person Name
- Robert Schnabel
- Contact Person Email
- schnabelrobert@hotmail.com
- Site Name
- Pannonia Maganorvosi Centrum Kft. (alternate listing)
- Principal Investigator Name
- Robert Schnabel
- Principal Investigator Email
- schnabelrobert@hotmail.com
- Contact Person Name
- Robert Schnabel
- Contact Person Email
- schnabelrobert@hotmail.com
Slovakia
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 24-09-2024
- Processing Time Days
- 7
- Number Of Sites
- 3
- Number Of Participants
- 13
Sites
- Site Name
- Fakultna Nemocnica Nitra
- Department Name
- Interna klinika
- Principal Investigator Name
- Peter Minarik
- Principal Investigator Email
- peterminarik@atlas.sk
- Contact Person Name
- Peter Minarik
- Contact Person Email
- peterminarik@atlas.sk
- Site Name
- F D Roosevelt University General Hospital Of Banska Bystrica
- Department Name
- II.Interna klinika-Gastroenterologia
- Principal Investigator Name
- Jozef Balaz
- Principal Investigator Email
- jbalaz@nspbb.sk
- Contact Person Name
- Jozef Balaz
- Contact Person Email
- jbalaz@nspbb.sk
- Site Name
- Alian s.r.o.
- Principal Investigator Name
- Martin Molnar
- Principal Investigator Email
- molnarm@centrum.sk
- Contact Person Name
- Martin Molnar
- Contact Person Email
- molnarm@centrum.sk
Poland
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 25-09-2024
- Processing Time Days
- 8
- Number Of Sites
- 12
- Number Of Participants
- 110
Sites
- Site Name
- Medicome Sp. z o.o.
- Principal Investigator Name
- Iwona Kobielusz-Gembala
- Principal Investigator Email
- iwonagembala@wp.pl
- Contact Person Name
- Iwona Kobielusz-Gembala
- Contact Person Email
- iwonagembala@wp.pl
- Site Name
- Amicare Sp. z o.o. S.K.
- Principal Investigator Name
- Rafal Drozda
- Principal Investigator Email
- r.drozda@amicare.pl
- Contact Person Name
- Rafal Drozda
- Contact Person Email
- r.drozda@amicare.pl
- Site Name
- Allmedica Badania Kliniczne Sp. z o.o.
- Principal Investigator Name
- Mikolaj Krzyzanowski
- Principal Investigator Email
- mikolaj.krzyzanowski@gmail.com
- Contact Person Name
- Mikolaj Krzyzanowski
- Contact Person Email
- mikolaj.krzyzanowski@gmail.com
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Beata Gawdis-Wojnarska
- Principal Investigator Email
- gawdis@twojaprzychodnia.com
- Contact Person Name
- Beata Gawdis-Wojnarska
- Contact Person Email
- gawdis@twojaprzychodnia.com
- Site Name
- NSZOZ Termedica – Centrum Badan Klinicznych
- Principal Investigator Name
- Jacek Lukasz Paszkowski
- Principal Investigator Email
- jacek.paszkowski@cmgrunwald.com
- Contact Person Name
- Jacek Lukasz Paszkowski
- Contact Person Email
- jacek.paszkowski@cmgrunwald.com
- Site Name
- Ip Clinic Sp. z o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Cezary Rudnicki
- Principal Investigator Email
- cezary.rudnicki@ipclinic.pl
- Contact Person Name
- Cezary Rudnicki
- Contact Person Email
- cezary.rudnicki@ipclinic.pl
- Site Name
- Kiepury Clinic Małgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno-Położnicza
- Principal Investigator Name
- Lukasz Firkowski
- Principal Investigator Email
- lukaszf@poczta.onet.pl
- Contact Person Name
- Lukasz Firkowski
- Contact Person Email
- lukaszf@poczta.onet.pl
- Site Name
- Dc-Med Sp. z o.o.
- Principal Investigator Name
- Witold Marczynski
- Principal Investigator Email
- w.marczynski@dc-med.pl
- Contact Person Name
- Witold Marczynski
- Contact Person Email
- w.marczynski@dc-med.pl
- Site Name
- Centrum Medyczne Oporow
- Principal Investigator Name
- Radoslaw Kempinski
- Principal Investigator Email
- radoslaw.kempinski@cmoporow.com
- Contact Person Name
- Radoslaw Kempinski
- Contact Person Email
- radoslaw.kempinski@cmoporow.com
- Site Name
- Centrum Zdrowia MDM
- Principal Investigator Name
- Piotr Liszka-Dalecki
- Principal Investigator Email
- piotr.liszka-dalecki@czmdm.pl
- Contact Person Name
- Piotr Liszka-Dalecki
- Contact Person Email
- piotr.liszka-dalecki@czmdm.pl
- Site Name
- Centrum Medyczne Medyk Sp. z o.o.
- Principal Investigator Name
- Rafal Filip
- Principal Investigator Email
- r.s.filip@wp.pl
- Contact Person Name
- Rafal Filip
- Contact Person Email
- r.s.filip@wp.pl
- Site Name
- EMC Instytut Medyczny S.A.
- Principal Investigator Name
- Patryk Smolinski
- Principal Investigator Email
- psmolinski@poczta.onet.pl
- Contact Person Name
- Patryk Smolinski
- Contact Person Email
- psmolinski@poczta.onet.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 25-09-2024
- Processing Time Days
- 8
- Number Of Sites
- 5
- Number Of Participants
- 33
Sites
- Site Name
- GASTRO JeKa s.r.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Ondrej Jelinek
- Principal Investigator Email
- ondra.jelinek@cmail.cz
- Contact Person Name
- Ondrej Jelinek
- Contact Person Email
- ondra.jelinek@cmail.cz
- Site Name
- Privatni gastroenterologicka ambulance s.r.o., MUDr. Zdenek Vlk
- Department Name
- Gastroenterology
- Principal Investigator Name
- Jiri Pumprla
- Principal Investigator Email
- research@vilazdravi.cz
- Contact Person Name
- Jiri Pumprla
- Contact Person Email
- research@vilazdravi.cz
- Site Name
- Hepato-Gastroenterologie HK s.r.o.
- Department Name
- Poliklinika III
- Principal Investigator Name
- Tomas Vanasek
- Principal Investigator Email
- tomas.vanasek@hepato-gastro.com
- Contact Person Name
- Tomas Vanasek
- Contact Person Email
- tomas.vanasek@hepato-gastro.com
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Dept of Gastroenterologie metabolismu a vyzivy
- Principal Investigator Name
- Pavel Svoboda
- Principal Investigator Email
- pavel.svoboda@fno.cz
- Contact Person Name
- Pavel Svoboda
- Contact Person Email
- pavel.svoboda@fno.cz
- Site Name
- Fakultni Nemocnice Bulovka
- Department Name
- Dept of Interni oddeleni
- Principal Investigator Name
- Martin Pesta
- Principal Investigator Email
- pestam@seznam.cz
- Contact Person Name
- Martin Pesta
- Contact Person Email
- pestam@seznam.cz
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 04-10-2024
- Processing Time Days
- 17
- Number Of Sites
- 9
- Number Of Participants
- 17
Sites
- Site Name
- Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD
- Principal Investigator Name
- Petko Karagyozov
- Principal Investigator Email
- p_karagyozov@bitex.bg
- Contact Person Name
- Petko Karagyozov
- Contact Person Email
- p_karagyozov@bitex.bg
- Site Name
- Alexandrovska University Hospital
- Principal Investigator Name
- Diana Petrova
- Principal Investigator Email
- d.petrova.stefanova@gmail.com
- Contact Person Name
- Diana Petrova
- Contact Person Email
- d.petrova.stefanova@gmail.com
- Site Name
- University Multiprofessional Hospital For Active Treatment Kanev AD
- Principal Investigator Name
- Galina Vasileva
- Principal Investigator Email
- galinakrasteva@mail.bg
- Contact Person Name
- Galina Vasileva
- Contact Person Email
- galinakrasteva@mail.bg
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Principal Investigator Name
- Ludmila Tankova
- Principal Investigator Email
- drtankova@abv.bg
- Contact Person Name
- Ludmila Tankova
- Contact Person Email
- drtankova@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
- Principal Investigator Name
- Kamen Danov
- Principal Investigator Email
- dr.danov@abv.bg
- Contact Person Name
- Kamen Danov
- Contact Person Email
- dr.danov@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Principal Investigator Name
- Zoya Spassova
- Principal Investigator Email
- zoya.spassova@hotmail.com
- Contact Person Name
- Zoya Spassova
- Contact Person Email
- zoya.spassova@hotmail.com
- Site Name
- Medical Center Medica Plus Ltd.
- Principal Investigator Name
- Lyubomir Kosturkov
- Principal Investigator Email
- kosturkov@mcmedicaplus.com
- Contact Person Name
- Lyubomir Kosturkov
- Contact Person Email
- kosturkov@mcmedicaplus.com
- Site Name
- Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD (alternate)
- Principal Investigator Name
- Petko Karagyozov
- Principal Investigator Email
- p_karagyozov@bitex.bg
- Contact Person Name
- Petko Karagyozov
- Contact Person Email
- p_karagyozov@bitex.bg
- Site Name
- Other listed Bulgarian site
- Contact Person Name
- Additional contacts listed in submission
Sponsor
Primary sponsor
- Full Name
- Arena Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA
- Responsibilities
- Regulatory (e.g. preparation of applications to CA and ethics committee); multiple operational roles per sponsorDuties
- Name
- Psi Cro AG
- Responsibilities
- Regulatory; Project Management for PSI countries; (Regional) Medical Monitoring for PSI enrolled patients
- Name
- Endpoint Clinical Inc.
- Responsibilities
- Interactive Voice Response System - treatment randomisation
- Name
- Clario
- Responsibilities
- Medical image
- Name
- Celerion
- Responsibilities
- Laboratory Analysis
Third parties
- {"country":"United States","full_name":"Medidata Solutions","duties_or_roles":"code 7","organisation_type":"Health care"}
- {"country":"United States","full_name":"Clario","duties_or_roles":"code 15; Medical image","organisation_type":"Health care"}
- {"country":"United States","full_name":"Steelgate Inc.","duties_or_roles":"code 15; Long-term storage of samples","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"code 15; Microbiome testing","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"code 15; Laboratory Analysis; Medical image","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Quest Diagnostics Inc.","duties_or_roles":"code 15; Clostridium difficile Toxin B testing, qualitative and real-time PCR, Ova & Parasite Testing","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Q Squared Solutions Holdings LLC (Valencia site)","duties_or_roles":"code 15; Laboratory Analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Acelabio (US) Inc.","duties_or_roles":"code 15; Laboratory Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"IQVIA","duties_or_roles":"codes 1,10,11,15,2,6,9; Regulatory (e.g. preparation of applications to CA and ethics committee)","organisation_type":"Health care"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code 15; Interactive Voice Response System - treatment randomisation","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code 15; Laboratory Analysis","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"codes 1,15 (Regulatory; Project Management for PSI countries and (Regional) Medical Monitoring for PSI enrolled patients), 2","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Celerion","duties_or_roles":"code 15; Laboratory Analysis","organisation_type":"Industry"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"code 15; Participant payment/ reimbursment","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Etrasimod Arginine Blue
- Active Substance
- Etrasimod arginine
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Maximum Dose
- 2 mg daily
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