A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Afimkibart: Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Placebo: Placebo matching IV afimkibart.
Study summary
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Eligibility
Sex
ALL
Min age
16 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Confirmed diagnosis of CD
* Moderately to severely active CD
* Bodyweight \>= 40 kilogram (kg)
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion Criteria:
* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
* Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
* Diagnosis of short gut or short bowel syndrome
* Presence of an ileostomy, colostomy or ileoanal pouch
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* Presence of abdominal or perianal abscess
* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Any past or current evidence of cancer of gastrointestinal tract, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Primary outcome measure(s)
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score — At Week 12 Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Percentage of Participants with Endoscopic Response — At Week 12 Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Trial sites (199)
Facility
City
Region
Status
Digestive Health Specialists of the Southeast
Dothan
Alabama
Recruiting
Sun City Clinical Research
Glendale
Arizona
Recruiting
Om Research LLC
Lancaster
California
Recruiting
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach
California
Recruiting
Empire Clinical Research
Pomona
California
Withdrawn
Stanford Medicine Outpatient Center
Redwood City
California
Recruiting
Clinical Applications Laboratories, Inc.
San Diego
California
Recruiting
Amicis Research Center
Santa Clarita
California
Recruiting
Peak Gastroenterology Associates
Colorado Springs
Colorado
Recruiting
J&A Clinical Research
Doral
Florida
Recruiting
Auzmer Research
Lakeland
Florida
Recruiting
Galenus Group Inc
Lehigh Acres
Florida
Recruiting
Homestead Associates in Research, Inc.
Miami
Florida
Recruiting
Allied Biomedical Research Institute, Inc
Miami
Florida
Recruiting
Rejuvaline Medical Research
Miami
Florida
Recruiting
Miami Beach Clinical Research Center
Miami Beach
Florida
Recruiting
Eminat Research Group
Miramar
Florida
Recruiting
Digestive and Liver Center of Florida
Orlando
Florida
Recruiting
Advanced Medical Research Center
Port Orange
Florida
Recruiting
Santos Research Center, CORP
Tampa
Florida
Recruiting
Cleveland Clinic Florida
Weston
Florida
Recruiting
Morehouse School Of Medicine
Atlanta
Georgia
Recruiting
The University of Chicago
Chicago
Illinois
Recruiting
University of Kansas Medical Center
Kansas City
Kansas
Recruiting
Robley Rex VA Medical Center
Louisville
Kentucky
Recruiting
One GI: GHP - Gastroenterology Health Partners Louisville
Louisville
Kentucky
Recruiting
Baton Rouge General Medical Center
Baton Rouge
Louisiana
Recruiting
Louisiana Research Center - GastroIntestinal Associates
Shreveport
Louisiana
Recruiting
Mercy Medical Center
Baltimore
Maryland
Recruiting
Chevy Chase Clinical Research
Chevy Chase
Maryland
Recruiting
University of Massachusetts Memorial Medical Center
North Worcester
Massachusetts
Recruiting
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming
Michigan
Recruiting
Gastrointestinal Associates Research
Flowood
Mississippi
Recruiting
Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital
Columbia
Missouri
Recruiting
Specialists in Gastroenterology
St Louis
Missouri
Recruiting
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon
New Hampshire
Recruiting
Virtua Crohns and Colitis Center
Moorestown
New Jersey
Recruiting
Robert Wood Johnson University Hospital
New Brunswick
New Jersey
Recruiting
Ellipsis Research Group
Brooklyn
New York
Recruiting
Intercity Gastroenterology
Fresh Meadows
New York
Recruiting
+ 159 more sites — see the full list on the official registry below.
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.
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