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
- Berlin, Dachau, Erlangen, Halle (Saale), Hanover, Jerichow, Kiel, Leipzig, Lueneburg, Oldenburg in Holstein, Rostock, and Ulm, GermanySee the 12 sites
- Phase
- Phase 2/3
Where in Germany
- DRK Kliniken BerlinBerlin, GermanyTaking people
- Medizinisches Versorgungszentrum DachauDachau, GermanyTaking people
- Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
- Studiengesellschaft BSF UG (haftungsbeschraenkt)Halle (Saale), GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Praxisgemeinschaft JerichowJerichow, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
- Eugastro GmbHLeipzig, GermanyTaking people
- Staedtisches Klinikum Lueneburg gGmbHLueneburg, GermanyTaking people
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbHOldenburg in Holstein, GermanyTaking people
- Rostock University Medical CenterRostock, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking 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.