A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
Recruiting · NCT07196722 · 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 study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
- Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2
- Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments
- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-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 naïve to advanced therapies (advanced drug therapy \[ADT\]-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 CD- (ADT-inadequate responder \[IR\]) as defined in the protocol
Exclusion criteria
- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention
- Presence of a stoma or ostomy
- Participants with presence of active fistulas may be included if there is no surgery needed
- Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
- Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization
Where it is running
60 locations listed across 22 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
- Alliance Research Institute, LLC - Canoga Park - Canoga Park, California, United States
- Southern California Research Center - Coronado, California, United States
- Om Research, LLC 1 - 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
- American Institute of Research - Cutler Bay, Florida, United States
- Nature Coast Clinical Research - Inverness, Florida, United States
- Green Leaf Clinical Trials - Jacksonville, Florida, United States
- Florida Research Center Inc. - Lakewood Rch, Florida, United States
- Sanchez Clinical Research, Inc - Miami, Florida, United States
- GCP Clinical Research - Tampa, Florida, United States
- Emory University - 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
- Kansas Gastroenterology, LLC - Wichita, Kansas, United States
- Tri-State Gastroenterology Assoc - Crestview Hills, Kentucky, United States
- Gastroenterology Clinic of Acadiana - Lafayette, Louisiana, 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
- Mayo Clinic 1 - Rochester, Minnesota, 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
- 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
- Baylor University Medical Center - Dallas, Texas, United States
- UT Southwestern Medical Center - Dallas, 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
Showing 60 of 370 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →