Tests icotrokinra against placebo in adults with active Crohn's disease
Tests icotrokinra in adults with moderately to severely active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Bydgoszcz, Bytom, Cracow, Lublin, Nowy Targ, Olsztyn, Poznan, Rzeszow, Sopot, Szczecin, Torun, Warsaw, Wroclaw, and Zamość, PolandSee the 31 sites
- Phase
- Phase 2/3
Where in Poland
- Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.Bydgoszcz, PolandTaking people
- Manermed Sp. z o.o.Bydgoszcz, PolandTaking people
- Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Małgorzata TrzaskaBydgoszcz, PolandTaking people
- Novamed Robert KoterasBytom, PolandTaking people
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.Cracow, PolandTaking people
- Malopolskie Badania Kliniczne Sp. z o.o.Cracow, PolandTaking people
- Promed P.Lach R.Glowacki Sp. j.Cracow, PolandTaking people
- Medrise Sp. z o.o.Lublin, PolandTaking people
- Uniwersytecki Szpital Kliniczny nr 4 w LublinieLublin, PolandTaking people
- Allmedica Badania Kliniczne Sp z o.o. Sp K.Nowy Targ, PolandTaking people
- Zaniewski Bilski Sp. z o.o.Olsztyn, PolandTaking people
- Rivermed Sp. z o.o.Poznan, PolandTaking people
- Termedia Sp. z o.o.Poznan, PolandTaking people
- Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.Poznan, PolandTaking people
- Centrum Medyczne Medyk Sp. z o.o. S.K.Rzeszow, PolandTaking people
- Endoskopia Sp z o.o.Sopot, PolandTaking people
- Sonomed Sp. z o.o.Szczecin, PolandTaking people
- Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.Szczecin, PolandTaking people
- GASTROMED Sp. z o.o.Torun, PolandTaking people
- Bodyclinic sp. z o.o. sp.k.Warsaw, PolandTaking people
- Care Access Polska Sp. Z o.o.Warsaw, PolandTaking people
- Etg Warszawa Sp. z o.o.Warsaw, PolandTaking people
- Medical Network Sp z o oWarsaw, PolandTaking people
- Medon Clinical Research Sp. z o.o.Warsaw, PolandTaking people
- Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.Warsaw, PolandTaking people
- Therapia Nova Sp z o.oWarsaw, PolandTaking people
- Wsd Medi Clinical Sp. z o.o.Warsaw, PolandTaking people
- Centrum Medyczne OporowWroclaw, PolandTaking people
- EMC Instytut Medyczny S.A.Wroclaw, PolandTaking people
- Vistamed & Vertigo Sp Z O OWroclaw, PolandTaking people
- Etg Zamosc Sp. z o.o.Zamość, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07196722EU 2025-521382-27-00
- Record updated
- 3 November 2026
- Original description
The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).Read full original descriptionShow less
A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Inclusion: Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD; Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score >=220 but <=450 and either mean daily SF count >=4, or mean daily AP score >=2; Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD >= 6 for participants with colonic or ileocolonic disease, and SES-CD >= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments; A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests; Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy [ADT]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD- (ADT-inadequate responder [IR]) as defined in the protocol.
Exclusion: Participants with presence of active fistulas may be included if there is no surgery needed; Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline; Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention; Presence of a stoma or ostomy; Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization.