Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
NCT07196748 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07196748
The ClinicalTrials.gov registry entry for NCT07196748 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 882 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07196748 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07196748?
The interventions under investigation include: Placebo (DRUG), Icotrokinra (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07196748?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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