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
- Chiba, Fukui-shi, Gamagōri, Hamamatsu, Higashiibaraki-gun, Hiroshima, Kagawa, Kagoshima, Kanazawa, Kashiwa, Kawagoe, Kitakyushu, Kumamoto, Kurume, Mitaka, Miyagi, Nagakute, Nagasaki, Nishinomiya-shi, Okinawa, Osaka, Saga, Sakura, Sapporo, Sendai, Shinjuku-ku, Shinjuku-Ku, and Sunto-gun, JapanSee the 35 sites
- Phase
- Phase 2/3
Where in Japan
- Juntendo University Hospital UrayasuChiba, JapanTaking people
- Fukui Prefectural HospitalFukui-shi, JapanTaking people
- Gamagori City HospitalGamagōri, JapanTaking people
- Hamamatsu University HospitalHamamatsu, JapanTaking people
- Matsuda HospitalHamamatsu, JapanTaking people
- National Hospital Organization Mito Medical CenterHigashiibaraki-gun, JapanTaking people
- Hiroshima University HospitalHiroshima, JapanTaking people
- Kagawa Prefectural Central HospitalKagawa, JapanTaking people
- Kagoshima IBD Gastroenterology ClinicKagoshima, JapanTaking people
- Kanazawa University HospitalKanazawa, JapanTaking people
- Matsuda Pediatrics Digestion ClinicKanazawa, JapanTaking people
- Tsujinaka Hospital KashiwanohaKashiwa, JapanTaking people
- Saitama Medical CenterKawagoe, JapanTaking people
- Hospital of the University of Occupational and Environmental HealthKitakyushu, JapanTaking people
- Japanese Red Cross Kumamoto HospitalKumamoto, JapanTaking people
- Takano HospitalKumamoto, JapanTaking people
- Kurume University HospitalKurume, JapanTaking people
- Kyorin University HospitalMitaka, JapanTaking people
- Takagi ClinicMiyagi, JapanTaking people
- Aichi Medical University HospitalNagakute, JapanTaking people
- Nagasaki University HospitalNagasaki, JapanTaking people
- Hyogo Medical University HospitalNishinomiya-shi, JapanTaking people
- Nakagami HospitalOkinawa, JapanTaking people
- National Hospital Organization Osaka National HospitalOsaka, JapanTaking people
- Osaka Metropolitan University HospitalOsaka, JapanTaking people
- Kinshukai Infusion ClinicOsaka, JapanNo longer taking part
- Saga University HospitalSaga, JapanTaking people
- Toho University Sakura Medical CenterSakura, JapanTaking people
- Hokkaido P.W.F.A.C. Sapporo-Kosei General HospitalSapporo, JapanTaking people
- Sapporo IBD ClinicSapporo, JapanTaking people
- Sapporo Tokushukai HospitalSapporo, JapanTaking people
- Tohoku University HospitalSendai, JapanTaking people
- Tokyo Yamate Medical CenterShinjuku-ku, JapanTaking people
- National Center for Global Health and MedicineShinjuku-Ku, JapanTaking people
- National Hospital Organization Shizuoka Medical CenterSunto-gun, JapanTaking 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.