A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
Condition(s) studied
Investigational drug(s) / intervention(s)
Icotrokinra: Icotrokinra tablet will be administered orally.
Placebo: Placebo tablet will be administered orally.
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).
Eligibility
Primary outcome measure(s)
- Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 — At Week I-12
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. - DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 — At Week M-40
Percentage of adult participants in clinical remission at Week M-40 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. - Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 — At Week M-40
Percentage of adolescent participants in clinical remission at Week M-40 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.
Trial sites (402)
| Facility | City | Region | Status |
|---|---|---|---|
| AZ Gastro Care | Chandler | Arizona | |
| Research Solutions of Arizona | Litchfield Park | Arizona | |
| Mayo Clinic | Scottsdale | Arizona | |
| Clinnova Research | Anaheim | California | |
| Southern California Research Center | Coronado | California | |
| Om Research LLC | Lancaster | California | |
| TLC Clinical Research Inc | Los Angeles | California | |
| GastroIntestinal Bioscience | Los Angeles | California | |
| Hoag Memorial Hospital | Newport Beach | California | |
| Om Research LLC 2 | Oxnard | California | |
| Stanford Medicine Children's Health | Palo Alto | California | |
| Clinical Applications Laboratories, Inc | San Diego | California | |
| Medical Associates Research Group, Inc. | San Diego | California | |
| University of California San Francisco | San Francisco | California | |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | |
| Nuvance Health Danbury Hospital | Danbury | Connecticut | |
| Connecticut Children's Medical Center | Hartford | Connecticut | |
| American Institute of Research | Cutler Bay | Florida | |
| Nature Coast Clinical Research | Inverness | Florida | |
| Florida Research Institute | Lakewood Rch | Florida | |
| GCP Clinical Research | Tampa | Florida | |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | |
| Children's Center for Digestive Health Care | Atlanta | Georgia | |
| Gastroenterolgy Associates of Central GA | Macon | Georgia | |
| IU Health University Hospital | Indianapolis | Indiana | |
| Cotton O'Neil Digestive Health Center | Topeka | Kansas | |
| Tri-State Gastroenterology Assoc | Crestview Hills | Kentucky | |
| Delta Research Partners, LLC | West Monroe | Louisiana | |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | |
| Woodholme Gastroenterology Associates | Glen Burnie | Maryland | |
| Westchester Putnam Gastroenterology | Carmel | New York | |
| Inflammatory Bowel Disease Center at NYU Langone | New York | New York | |
| Manhattan Clinical Research LLC | New York | New York | |
| Icahn School of Medicine at Mount Sinai | New York | New York | |
| Weill Cornell Medical College | New York | New York | |
| Lenox Hill Hospital | New York | New York | |
| New York Gastroenterology Associates | New York | New York | |
| University of North Carolina | Chapel Hill | North Carolina | |
| Atrium Health | Charlotte | North Carolina | |
| Digestive Disease Specialists Inc | Oklahoma City | Oklahoma |
+ 362 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07196748 on ClinicalTrials.gov ↗ ← All trials in China