Print

Purpose

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).

Condition

Eligibility

Eligible Ages
Between 16 Years and 80 Years
Eligible Sex
All
Accepts 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, 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Afimkibart 		Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
  • Drug: Afimkibart
    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RG6631
    • RO7790121
Placebo Comparator
Placebo 		Participants will receive placebo IV followed by afimkibart SC injection.
  • Drug: Placebo
    Placebo matching IV afimkibart.

Recruiting Locations

Sun City Clinical Research
Glendale, Arizona 85304

Om Research LLC
Lancaster, California 93534

Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California 92663

Stanford Medicine Outpatient Center
Redwood City, California 94063

Clinical Applications Laboratories, Inc.
San Diego, California 92103

Amicis Research Center
Santa Clarita, California 91355

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907

J&A Clinical Research
Doral, Florida 33126

Homestead Associates in Research, Inc.
Miami, Florida 33033

Allied Biomedical Research Institute, Inc
Miami, Florida 33155

Rejuvaline Medical Research
Miami, Florida 33155

Miami Beach Clinical Research Center
Miami Beach, Florida 33141

Eminat Research Group
Miramar, Florida 33027

Digestive and Liver Center of Florida
Orlando, Florida 32825

Advanced Medical Research Center
Port Orange, Florida 32127

Santos Research Center, CORP
Tampa, Florida 33615

Cleveland Clinic Florida
Weston, Florida 33331

The University of Chicago
Chicago, Illinois 60637

Robley Rex VA Medical Center
Louisville, Kentucky 40206

Baton Rouge General Medical Center
Baton Rouge, Louisiana 70809

Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana 71105

Mercy Medical Center
Baltimore, Maryland 21202

Chevy Chase Clinical Research
Chevy Chase, Maryland 20815

University of Massachusetts Memorial Medical Center
North Worcester, Massachusetts 01655

Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan 49519

Gastrointestinal Associates Research
Flowood, Mississippi 39232

Virtua Crohns and Colitis Center
Moorestown, New Jersey 08057

Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901

Ellipsis Research Group
Brooklyn, New York 11215

Intercity Gastroenterology
Fresh Meadows, New York 11366

James J Peters Veterans Affairs Medical Center
The Bronx, New York 10468

Digestive Disease Medicine of Central New York
Utica, New York 13502

Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina 28207

Clinical Inquest Center
Beavercreek, Ohio 45431

Cleveland Clinic Foundation
Cleveland, Ohio 44195

Vanderbilt University Medical Center
Nashville, Tennessee 37212-1375

University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
Dallas, Texas 75390-8565

GI Alliance - Fort Worth
Fort Worth, Texas 76104

GI Alliance
Garland, Texas 75044

Integrity Advanced Therapeutics PLLC
Houston, Texas 77090

Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
Lubbock, Texas 79410

Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas 78212

University of Texas Health Center at Tyler
Tyler, Texas 75708

TDDC GI Alliance research Webster
Webster, Texas 77598

University Physicians and Surgeons Inc, dba Marshall Health
Huntington, West Virginia 25701

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GA45332 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.