A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting · NCT07196748 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
IcotrokinraPlacebo
What this trial is about
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).
Who can take part
Age range
12 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC
- Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy
- An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy
- Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0)
- Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
- Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder \[IR\]) as defined in the protocol
Exclusion criteria
- Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
- Presence of a stoma
- Presence or history of a fistula
- Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
- History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention
Where it is running
60 locations listed across 21 US states.
- AZ Gastro Care - Chandler, Arizona, United States
- Research Solutions of Arizona - Litchfield Park, Arizona, United States
- Mayo Clinic - Scottsdale, Arizona, United States
- Clinnova Research - Anaheim, California, United States
- Southern California Research Center - Coronado, California, United States
- Om Research LLC - Lancaster, California, United States
- TLC Clinical Research Inc - Los Angeles, California, United States
- GastroIntestinal Bioscience - Los Angeles, California, United States
- Hoag Memorial Hospital - Newport Beach, California, United States
- Om Research LLC 2 - Oxnard, California, United States
- Clinical Applications Laboratories, Inc - San Diego, California, United States
- Medical Associates Research Group, Inc. - San Diego, California, United States
- University of California San Francisco - San Francisco, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Nuvance Health Danbury Hospital - Danbury, Connecticut, United States
- Connecticut Children's Medical Center - Hartford, Connecticut, United States
- American Institute of Research - Cutler Bay, Florida, United States
- Nature Coast Clinical Research - Inverness, Florida, United States
- Florida Research Institute - Lakewood Rch, Florida, United States
- GCP Clinical Research - Tampa, Florida, United States
- Atlanta Gastroenterology Associates - Atlanta, Georgia, United States
- Children's Center for Digestive Health Care - Atlanta, Georgia, United States
- Gastroenterolgy Associates of Central GA - Macon, Georgia, United States
- IU Health University Hospital - Indianapolis, Indiana, United States
- Cotton O'Neil Digestive Health Center - Topeka, Kansas, United States
- Tri-State Gastroenterology Assoc - Crestview Hills, Kentucky, United States
- Delta Research Partners, LLC - West Monroe, Louisiana, United States
- Chevy Chase Clinical Research - Chevy Chase, Maryland, United States
- Woodholme Gastroenterology Associates - Glen Burnie, Maryland, United States
- Westchester Putnam Gastroenterology - Carmel, New York, United States
- Inflammatory Bowel Disease Center at NYU Langone - New York, New York, United States
- Manhattan Clinical Research LLC - New York, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Weill Cornell Medical College - New York, New York, United States
- Lenox Hill Hospital - New York, New York, United States
- New York Gastroenterology Associates - New York, New York, United States
- University of North Carolina - Chapel Hill, North Carolina, United States
- Atrium Health - Charlotte, North Carolina, United States
- Digestive Disease Specialists Inc - Oklahoma City, Oklahoma, United States
- The Oregon Clinic - Portland, Oregon, United States
- Susquehanna Research Group - Harrisburg, Pennsylvania, United States
- Penn State Milton S Hershey Medical Ctr - Hershey, Pennsylvania, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Jefferson Digestive Health Institute - Philadelphia, Pennsylvania, United States
- University Gastroenterology - Providence, Rhode Island, United States
- Digestive Disease Associates - Rock Hill, South Carolina, United States
- The University of Texas at Austin - Austin, Texas, United States
- DFW Clinical Trials - Carrollton, Texas, United States
- Victorium Clinical Research - Houston, Texas, United States
- Southern Star Research Institute, LLC - San Antonio, Texas, United States
- GI Alliance Southlake - Southlake, Texas, United States
- Tyler Research Institute, LLC - Tyler, Texas, United States
- Gastroenterology Associates of Tidewater - Chesapeake, Virginia, United States
- Blue Ridge Medical Research - Lynchburg, Virginia, United States
- GI Alliance Tacoma - Tacoma, Washington, United States
- GEDYT - AAI, Argentina
- Universitaetsklinikum der RWTH Aachen - Aachen, Germany
- Haemek Medical Center - Afula, Israel
- Alingsas lasarett - Allingsas, Sweden
- Hospital Sultanah Bahiyah - Alor Star, Malaysia
Showing 60 of 401 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →