Status:
Enrolling

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

Phase
III
Age
16-80
Sponsor
Hoffmann-La Roche
Enrollment code
600
Last Updated
Jun 22, 2025
Locations
114 Countries

Overview

Condition/disease
Crohn's Disease
Modalities
Immunotherapy, Monoclonal Antibody
Trial drugs
PF-06480605 
Clinicaltrials.gov ID

Brief 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).

Trial locations

Found 114 sites

Tyler Research Institute, LLC

USA - TX - Tyler

Monroe Biomedical Research

USA - NC - Monroe

Hi Tech and Global Research, LLC

USA - FL - Coral Gables

University Gastroenterology

USA - RI - Providence

Delta Gastroenterology & Endoscopy Center

USA - MS - Southaven

Quality Medical Research

USA - TN - Nashville

Clinical Research of Osceola, LLC

USA - FL - Kissimmee

Gastro Intestinal Research Institute of Northern Ohio

USA - OH - Westlake

Grand Teton Research Group, PLLC

USA - ID - Idaho Falls

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan

USA - AL - Dothan

Guardian Angel Research Center, LLC

USA - FL - Tampa

GI Alliance - Southlake

USA - TX - Southlake

Ohio Gastroenterology Group

USA - OH - Columbus

Gastroenterology Associates and Endoscopy Center of North Mississippi

USA - MS - Oxford

Gastroenterology Research of America, LLC

USA - TX - San Antonio

Illinois Gastroenterology Group-Glenview powered by GI Alliance

USA - IL - Glenview

Access Research Institute

USA - FL - Brooksville

TDDC dba GI Alliance Research

USA - TX - Mansfield

Dayton Gastroenterology, Inc.

USA - OH - Beavercreek

Theia Clinical Research Centers, LLC

USA - FL - Temple Terrace

Emeritas Research Group

USA - VA - Lansdowne Town Center

Kansas Gastroenterology, LLC under Clinical Trials Network

USA - KS - Wichita

Peak Gastroenterology Surgery Center

USA - CO - Lone Tree

Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater

USA - VA - Chesapeake

The Ohio State University Wexner Medical Center

USA - OH - Columbus

DiGiovanna Inst for Med Ed&Res

USA - NY - North Massapequa

Gastroenterology Group of Rochester under CTNx

USA - NY - Rochester

Atlanta Gastroenterology Associates

USA - GA - Atlanta

Texas Clinical Research Institute, LLC

USA - TX - Arlington

Nodal Medical Center Research - NMC

USA - FL - Tampa

Tri-State Gastroenterology Associates

USA - KY - Crestview Hills

Gastroenterology Consultants and Endoscopy Center of Southwest Virginia

USA - VA - Roanoke

Gastroenterology Associates of Central Georgia

USA - GA - Macon

Gastroenterology Health Partners, PLLC

USA - IN - New Albany

Gastroenterology Health Partners, PLLC

USA - KY - Louisville

Digestive Healthcare of Georgia

USA - GA - Atlanta

Valley View Internal Medicine

USA - CA - Garden Grove

Arizona Digestive Health, P.C (ADH)

USA - AZ - Sun City

The First Affiliated Hospital of Ningbo University

CN - Ningbo City

The First Affiliate Hospital of Guangxi Medical University

CN - Nanning

WIP Warsaw IBD Point Profesor Kierkus

PL - Warszawa

Queen Anne Street Medical Centre

GB - London

Medical Care & Research SA de CV

MX - Mérida

Klinical Investigations Group LLC

PR - San Juan

Brigham and Women's Hospital

USA - MA - Boston

Florida Research Institute - Lakewood

USA - FL - Lakewood Ranch

Ren Min Hospital Affiliated Wu Han University

CN - Wuhan

Zhejiang Province Traditional Chinese Medical Hospital

CN - Hangzhou City

The sixth affiliated hospital of Sun Yat-Sen University

CN - Guangzhou City

Frontier Clinical Re search, LLC

USA - PA - Uniontown

The second Affiliated Hospital of Guangzhou Medical University

CN - Guangzhou City

The 1st Affiliated Hospital of Nanchang Unversity

CN - Nanchang City

LCC Medical Research Institute, LLC

USA - FL - Miami

South Edmonton Gastroenterology

Canada - AB - Edmonton

Queens Village Medical Care

USA - NY - Queens Village

Taizhou Hospital Of Zhejiang Province

CN - Taizhou City

Peking University Shenzhen Hospital

CN - Shenzhen

Sir Run Run Shaw Hospital Zhejiang University

CN - Hangzhou City

Boca Clinical Trials Mexico S.C. (Guadalajara)

MX - Guadalajara

the First Hospital of Jilin University

CN - Changchun

Zhongshan Hospital Xiamen University

CN - Xiamen

Chongqing General Hospital

CN - Chongqing City

The Central Hospital of Wuhan

CN - Wuhan City

Huizhou Central People's Hospital

CN - Huizhou

Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?

PL - Wroc?aw

Third Xiangya Hospital Centrel South University

CN - Changsha

West China Hospital of Sichuan University

CN - Chengdu City

Charite - Campus Benjamin Franklin

DE - Berlin

Clinica Universidad de Los Andes

CL - Santiago

Hospital Guillermo Grant Benavente

CL - Concepcion

Universitaetsklinikum Halle (Saale)

DE - Halle

The First Affiliated Hospital Of Fujian Medical University

CN - Fuzhou City

The Second Affiliated Hospital of Zhengzhou University

CN - Zhengzhou

CHU Saint Etienne - Hôpital Nord

FR - Saint Etienne

Rocky Mountain Gastroenterology

USA - CO - Littleton

Hospital Britanico

AR - Ciudad Autonoma Bs As

Gastroenterology Associates, PA PA of Greenville

USA - SC - Greenville

Michigan Center of Medical Research

USA - MI - Farmington Hills

Cliniques Universitaires St-Luc

BE - Bruxelles

Klinikum Mannheim GmbH Universitätsklinikum

DE - Mannheim

CEMDOE (Centro Médico de Diabetes, Obesidad y Especialidades)

DO - Santo Domingo

CHU de Rennes - Hopital de Pontchaillo

FR - Rennes

Obudai Egeszsegugyi Centrum Kft.

HU - Budapest

Eligibility criteria

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

Study plan

Experimental: Arm 1: 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.

Experimental: Arm 2: Afimkibart

Participants will receive afimkibart IV followed by afimkibart SC injection.
Drug
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Allocation: Randomized

Outcome measures

Primary outcome measures

  • Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score (At Week 52)
  • Percentage of Participants with Endoscopic Response (At Week 52)

Secondary outcome measures

  • Percentage of Participants with Clinical Remission (At Week 12)
  • Percentage of Participants with Endoscopic Response (At Week 12)

More information

Official title

A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease

Estimated trial completion date

Dec 31, 2033
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