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A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, Ulcerative
Clinicaltrials.gov:
EU CTIS:
#2025-521381-10-00
Other:
#77242113UCO3001
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Trials at a glance
Status
Enrolling
Condition
Colitis, Ulcerative
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Icotrokinra
Placebo
Age
12+ years old
Biological sex
All
Placebo?
Yes
Trial start date
October 1, 2025
Trial end date
January 13, 2032
CT.gov ID
#NCT07196748
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A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and
tolerability of oral icotrokinra as therapy in adult and adolescent participants with
moderately to severely active ulcerative colitis (UC, a chronic disease of the large
intestine in which the lining of the colon becomes inflamed and develops tiny open
ulcers).
Primary outcome measures
- Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12
- DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40
- Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40
Secondary outcome measures
- DB Induction Study: Percentage of Adult Participants in Clinical Response at Week I-12
- DB Induction Study: Percentage of Adult Participants with Endoscopic Improvement at Week I-12
- DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-12
- DB Induction Study: Percentage of Adult Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12
- DB Induction Study: Percentage of Adult Participants with Histologic-Endoscopic Mucosal Improvement (HEMI) at Week I-12
- DB Induction Study: Percentage of Adult Participants with Fatigue Response at Week I-12
- DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-4
- DB Induction Study: Percentage of Adult Participants in Endoscopic Remission at Week I-12
- DB Induction Study: Percentage of Adult Participants with No Bowel Urgency at Week I-12
- DB Induction Study: Percentage of Adult Participants with No Abdominal Pain at Week I-12
- DB Induction Study: Percentage of Adult Participants with No Bowel Incontinence at Week I-12
- DB Induction Study: Percentage of Adult Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
- DB Maintenance Study: Percentage of Adult Participants with Endoscopic Improvement at Week M-40
- DB Maintenance Study: Percentage of Adult Participants in Symptomatic Remission at Week M-40
- DB Maintenance Study: Percentage of Adult Participants with 90-day Corticosteroid-free Clinical Remission at Week M-40
- DB Maintenance Study: Percentage of Adult Participants with HEMI at Week M-40
- DB Maintenance Study: Percentage of Adult Participants with IBDQ Remission at Week M-40
- DB Maintenance Study: Percentage of Adult Participants in Endoscopic Remission at Week M-40
- DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 Among the Participants who had Achieved Clinical Remission at Maintenance Baseline
- DB Maintenance Study: Percentage of Adult Participants in Histologic-Endoscopic Mucosal Remission at Week M-40
- DB Maintenance Study: Percentage of Adult Participants with Fatigue Response at Week M-40
- DB Maintenance Study: Percentage of Adult Participants with Disease Clearance at Week M-40
- DB Maintenance Study: Percentage of Adult Participants with No Bowel Urgency at Week M-40
- DB Maintenance Study: Percentage of Adult Participants with No Abdominal Pain at Week M-40
- DB Maintenance Study: Percentage of Adult Participants with No Bowel Incontinence at Week M-40
- DB Maintenance Study: Percentage of Adult Participants with AEs and SAEs
- OL Induction Phase: Percentage of Adolescent Participants in Clinical Response at Week I-12
- OL Induction Phase: Percentage of Adolescent Participants in Clinical Remission at Week I-12
- OL Induction Phase: Percentage of Adolescent Participants with HEMI at Week I-12
- OL Induction Phase: Percentage of Adolescent Participants with Endoscopic Improvement at Week I-12
- OL Induction Phase: Percentage of Adolescent Participants in Symptomatic Remission at Week I-12
- OL Induction Phase: Percentage of Adolescent Participants in Endoscopic Remission at Week I-12
- OL Induction Phase: Percentage of Adolescent Participants in Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week I-12
- OL Induction Phase: Percentage of Adolescent Participants with AEs and SAEs
- OL Maintenance Study: Percentage of Adolescent Participants with Endoscopic Improvement at Week M-40
- OL Maintenance Phase: Percentage of Adolescent Participants in Symptomatic Remission at Week M-40
- OL Maintenance Phase: Percentage of Adolescent Participants in 90-day Corticosteroid-free Clinical Remission at Week M-40
- OL Maintenance Phase: Percentage of Adolescent Participants with HEMI at Week M-40
- OL Maintenance Phase: Percentage of Adolescent Participants with Histologic-Endoscopic Mucosal Remission at Week M-40
- OL Maintenance Phase: Percentage of Adolescent Participants with Endoscopic Remission at Week M-40
- OL Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 Among the Participants who had Achieved Clinical Remission at Maintenance Baseline
- OL Maintenance Phase: Percentage of Adolescent Participants in Clinical Response at Week M-40 Among the Participants who had Achieved Clinical Response at Maintenance Baseline
- OL Maintenance Phase: Percentage of Adolescent Participants in PUCAI Remission at Week-40
- OL Maintenance Phase: Percentage of Adolescent Participants with AEs and SAEs
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