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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 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.

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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).

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

FieldValue
Enrollment Target 882 participants
Start Date 2025-10-01
Est. Completion 2032-01-13
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT07196748

The ClinicalTrials.gov registry entry for NCT07196748 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 882 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 374-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (136% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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