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A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
Crohn Disease
Clinicaltrials.gov:
EU CTIS:
#2025-521382-27-00
Other:
#77242113CRD3001
Trials at a glance
Status
Enrolling
Condition
Crohn Disease
Trial type
Interventional
Trial phase
Phase 2/Phase 3
Investigational
product
product
Icotrokinra
Placebo
Age
18+ years old
Biological sex
All
Placebo?
Yes
Trial start date
October 3, 2025
Trial end date
October 6, 2032
CT.gov ID
#NCT07196722
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study 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).
Primary outcome measures
- Induction Study 1: Number of Participants with Clinical Response at Week 12
- Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint)
- Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint)
- Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint)
- Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)
Secondary outcome measures
- Induction Study 1: Number of Participants with Clinical Remission at Week 12
- Induction Study 1: Number of Participants with Endoscopic Response at Week 12
- Induction Study 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Induction Study 2: Number of Participants with Patient Reported Outcomes (PRO)-2 Remission at Week 12
- Induction Study 2: Number of Participants with Clinical Response at Week 12
- Induction Study 2: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 12
- Induction Study 2: Number of Participants with Clinical Response at Week 4
- Induction Study 2: Number of Participants with Endoscopic Remission at Week 12
- Induction Study 2: Number of Participants with Deep Remission at Week 12
- Induction Study 2: Number of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
- Induction Study 2: Number of Participants with Fatigue Response at Week 12
- Induction Study 2: Number of Participants with Clinical Remission at Week 4
- Induction Study 2: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 12
- Induction Study 2: Number of Participants with AEs and SAEs
- Maintenance Study: Number of Participants with PRO-2 remission at Week 40
- Maintenance Study: Number of Participants with Endoscopic Remission at Week 40
- Maintenance Study: Number of Participants with 90-Day Corticosteroid-Free Clinical Remission at Week 40
- Maintenance Study: Number of Participants with Maintenance of Clinical Remission at Week 40
- Maintenance Study: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 40
- Maintenance Study: Number of Participants with Deep Remission at Week 40
- Maintenance Study: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 40
- Maintenance Study: Number of Participants with IBDQ Remission at Week 40
- Maintenance Study: Number of Participants with Fatigue Response at Week 40
- Maintenance Study : Number of Participants with AEs and SAEs
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