A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

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

  • Moderately to Severely Active Crohns Disease

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 5295985, Arizona 5551752 85304

Om Research LLC
Lancaster 5364940, California 5332921 93534

Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach 5376890, California 5332921 92663

Amicis Research Center
Santa Clarita 5393049, California 5332921 91355

Peak Gastroenterology Associates
Colorado Springs 5417598, Colorado 5417618 80907

J&A Clinical Research
Doral 4153471, Florida 4155751 33126

Homestead Associates in Research, Inc.
Miami 4164138, Florida 4155751 33033

Allied Biomedical Research Institute, Inc
Miami 4164138, Florida 4155751 33155

Rejuvaline Medical Research
Miami 4164138, Florida 4155751 33155

Miami Beach Clinical Research Center
Miami Beach 4164143, Florida 4155751 33141

Eminat Research Group
Miramar 4164601, Florida 4155751 33027

Digestive and Liver Center of Florida
Orlando 4167147, Florida 4155751 32825

Advanced Medical Research Center
Port Orange 4169156, Florida 4155751 32127

Santos Research Center, CORP
Tampa 4174757, Florida 4155751 33615

The University of Chicago
Chicago 4887398, Illinois 4896861 60637

Robley Rex VA Medical Center
Louisville 4299276, Kentucky 6254925 40206

Baton Rouge General Medical Center
Baton Rouge 4315588, Louisiana 4331987 70809

Louisiana Research Center - GastroIntestinal Associates
Shreveport 4341513, Louisiana 4331987 71105

Mercy Medical Center
Baltimore 4347778, Maryland 4361885 21202

Chevy Chase Clinical Research
Chevy Chase 4351335, Maryland 4361885 20815

University of Massachusetts Memorial Medical Center
North Worcester 4945817, Massachusetts 6254926 01655

Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming 5015618, Michigan 5001836 49519

Gastrointestinal Associates Research
Flowood 4426822, Mississippi 4436296 39232

Virtua Crohns and Colitis Center
Moorestown 4503106, New Jersey 5101760 08057

Ellipsis Research Group
Brooklyn 5110302, New York 5128638 11215

Intercity Gastroenterology
Fresh Meadows 5118005, New York 5128638 11366

James J Peters Veterans Affairs Medical Center
The Bronx 5110266, New York 5128638 10468

Digestive Disease Medicine of Central New York
Utica 5142056, New York 5128638 13502

Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte 4460243, North Carolina 4482348 28207

Clinical Inquest Center
Beavercreek 4506008, Ohio 5165418 45431

Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37212-1375

University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
Dallas 4684888, Texas 4736286 75390-8565

GI Alliance
Garland 4693003, Texas 4736286 75044

Integrity Advanced Therapeutics PLLC
Houston 4699066, Texas 4736286 77090

Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio 4726206, Texas 4736286 78212

University of Texas Health Center at Tyler
Tyler 4738214, Texas 4736286 75708

University Physicians and Surgeons Inc, dba Marshall Health
Huntington 4809537, West Virginia 4826850 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