A Study to Assess the Efficacy and Safety of Induction and Maintenance 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. Placebo matching SC afimkibart.
Study summary
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance 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
* 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, definite low-grade or high-grade colonic dysplasia
* 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 52 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 52 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 (374)
Facility
City
Region
Status
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Dothan
Alabama
Recruiting
Mayo Clinic Hospital
Phoenix
Arizona
Recruiting
Arizona Digestive Health, P.C (ADH)
Sun City
Arizona
Recruiting
University of Arizona-CATS Research Center
Tucson
Arizona
Recruiting
Valley View Internal Medicine
Garden Grove
California
Recruiting
310 Clinical Research
Inglewood
California
Recruiting
UCSD Medical Center
La Jolla
California
Recruiting
University of California San Diego
La Jolla
California
Recruiting
Gastro Care Associates
Lancaster
California
Recruiting
Om Research LLC
Lancaster
California
Recruiting
United Gastroenterologists
Los Alamitos
California
Recruiting
Acclaim Clinical Research, Inc.
San Diego
California
Recruiting
Kaiser Permanente
San Francisco
California
Recruiting
UCSF/Medical Center at Mount Zion
San Francisco
California
Recruiting
Rocky Mountain Gastroenterology
Littleton
Colorado
Recruiting
Peak Gastroenterology Surgery Center
Lone Tree
Colorado
Recruiting
Access Research Institute
Brooksville
Florida
Recruiting
Gastro Florida
Clearwater
Florida
Recruiting
HealthMed Clinical Center Inc.
Coral Gables
Florida
Recruiting
Hi Tech and Global Research, LLC
Coral Gables
Florida
Recruiting
The Sister Life Research
Hialeah
Florida
Recruiting
NeoClinical Research
Hialeah
Florida
Recruiting
Clinical Research of Osceola, LLC
Kissimmee
Florida
Recruiting
Florida Research Institute - Lakewood
Lakewood Rch
Florida
Recruiting
LCC Medical Research Institute, LLC
Miami
Florida
Recruiting
Ambert Medical Research
Miami
Florida
Withdrawn
Orlando Regional Healthcare
Orlando
Florida
Recruiting
Nodal Medical Center Research - NMC
Tampa
Florida
Recruiting
University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa
Florida
Recruiting
Guardian Angel Research Center, LLC
Tampa
Florida
Recruiting
Theia Clinical Research Centers, LLC
Temple Terrace
Florida
Recruiting
Cleveland Clinic Florida
Weston
Florida
Recruiting
Florida Medical Clinic - Orlando Health
Zephyrhills
Florida
Recruiting
Digestive Healthcare of Georgia
Atlanta
Georgia
Recruiting
Atlanta Gastroenterology Associates
Atlanta
Georgia
Recruiting
Gastroenterology Associates of Central Georgia
Macon
Georgia
Recruiting
Grand Teton Research Group, PLLC
Idaho Falls
Idaho
Recruiting
Northwestern Memorial Hospital
Chicago
Illinois
Recruiting
Illinois Gastroenterology Group-Glenview powered by GI Alliance
Glenview
Illinois
Recruiting
GI Alliance - Gurnee
Gurnee
Illinois
Recruiting
+ 334 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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