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NCT07196748 · ClinicalTrials.gov registry record · Phase 3
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 882
- Enrollment target
- 20
- Study locations
NCT07196748: Recruiting Phase 3 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
NCT07196748 is a Phase 3 study of Colitis, Ulcerative that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 882 participants, above the 374-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (136% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07196748, a Phase 3 study of Colitis, Ulcerative, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 882 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Icotrokinra
Study Locations (20)
California
- Clinnova Research - Anaheim
- Southern California Research Center - Coronado
- Om Research LLC - Lancaster
- TLC Clinical Research Inc - Los Angeles
- GastroIntestinal Bioscience - Los Angeles
- Om Research LLC - Oxnard
- Clinical Applications Laboratories, Inc - San Diego
- Medical Associates Research Group, Inc. - San Diego
Florida
- American Institute of Research - Cutler Bay
- Nature Coast Clinical Research - Inverness
- Florida Research Institute - Lakewood Rch
- GCP Clinical Research - Tampa
Georgia
- Atlanta Gastroenterology Associates - Atlanta
- Children's Center for Digestive Health Care - Atlanta
- Gastroenterolgy Associates of Central GA - Macon
Connecticut
- Nuvance Health Danbury Hospital - Danbury
- Connecticut Children's Medical Center - Hartford
Arizona
- AZ Gastro Care - Chandler
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Kansas
- Cotton O'Neil Digestive Health Center - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 882 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2032-01-13 |
| Phase | Phase 3 |
What NCT07196748 shows while recruiting
NCT07196748 is an interventional study that assigns participants to a tested intervention. The registered 882 participants enrollment target is mid-sized for trials with a published cap, above the 374-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (136% higher).
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07196748 names 20 study sites across 7 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT07196748 about?
NCT07196748 is a clinical study titled "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 col...
What is the current status of trial NCT07196748?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 882 participants. The study started on 2025-10-01. Estimated completion is 2032-01-13.
What conditions does trial NCT07196748 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT07196748?
The interventions under investigation include: Placebo (DRUG), Icotrokinra (DRUG).
Who is sponsoring clinical trial NCT07196748?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07196748 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colitis, Ulcerative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07196748's enrollment target sits among peer trials
882 5th of 28 higher than 24 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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