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
- Bangalore, Bengaluru, Bhubaneswar, Gurugram, Hyderabad, Jaipur, Kochi, Ludhiana, Ludhiāna, Mumbai, New Delhi, Patna, Secunderabad, and Surat, IndiaSee the 19 sites
- Phase
- Phase 2/3
Where in India
- Mazumdar Shaw Medical Centre - Narayana Hrudayalaya LimitedBangalore, IndiaTaking people
- Aster CMI HospitalBengaluru, IndiaTaking people
- SUM Ultimate MedicareBhubaneswar, IndiaTaking people
- Fortis Memorial Research InstituteGurugram, IndiaTaking people
- Asian Institute Of GastroenterologyHyderabad, IndiaTaking people
- Yashoda Super Speciality HospitalsHyderabad, IndiaTaking people
- S. R. Kalla Memorial General HospitalJaipur, IndiaTaking people
- Lisie HospitalKochi, IndiaTaking people
- Dayanand Medical College & Hospital, Tagore Nagar, Civil LinesLudhiana, IndiaTaking people
- Fortis HospitalLudhiāna, IndiaTaking people
- P D Hinduja National Hospital and Medical Research CenterMumbai, IndiaTaking people
- All India Institute of Medical SciencesNew Delhi, IndiaTaking people
- GB Pant Institute of Post Graduate Medical Education & ResearchNew Delhi, IndiaTaking people
- Indraprastha Apollo HospitalNew Delhi, IndiaTaking people
- Sir Ganga Ram HospitalNew Delhi, IndiaTaking people
- All India Institute of Medical SciencesPatna, IndiaTaking people
- Yashoda Super Speciality Hospitals 1Secunderabad, IndiaTaking people
- Gujarat Gastro and Vascular HospitalSurat, IndiaTaking people
- SIDS (Surat Institute of Digestive Sciences) Hospital and Research CentreSurat, IndiaTaking 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.