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

Official title

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

Overview

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).

Interventions

• Drug Afimkibart
  Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
• Drug Placebo
  Placebo matching IV afimkibart.

Primary outcome measures

• Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score [Time frame: At Week 12]
• Percentage of Participants with Endoscopic Response [Time frame: At Week 12]

Secondary outcome measures (12)

• Percentage of Participants with Symptomatic Remission [Time frame: At Week 12]
• Percentage of Participants with Endoscopic Remission [Time frame: At Week 12]
• Percentage of Participants with Ulcer-free Endoscopy [Time frame: At Week 12]
• Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF) [Time frame: Baseline through Week 12]
• Average of Daily Abdominal Pain Scores in the Past Week (APS) [Time frame: Baseline through Week 12]
• Bowel Urgency [Time frame: Baseline to Week 12]
• Fatigue [Time frame: Baseline to Week 12]
• Inflammatory Bowel Disease Questionnaire (IBDQ) Score [Time frame: Baseline to Week 12]
• Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants [Time frame: At Week 12]
• Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants [Time frame: At Week 12]
• Percentage of Participants with Clinical Response [Time frame: At Week 12]
• Percentage of Participants with Symptomatic Response [Time frame: At Week 12]

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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 60 centers

• Digestive Health Specialists of the Southeast — Dothan
• Sun City Clinical Research — Glendale
• Om Research LLC — Lancaster
• Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education — Newport Beach
• Empire Clinical Research — Pomona
• Stanford Medicine Outpatient Center — Redwood City
• Clinical Applications Laboratories, Inc. — San Diego
• Amicis Research Center — Santa Clarita
• … and 52 more centers

China · 18 centers

Center list to be confirmed — check the primary protocol.

Poland · 17 centers

Center list to be confirmed — check the primary protocol.

India · 13 centers

Center list to be confirmed — check the primary protocol.

France · 11 centers

Center list to be confirmed — check the primary protocol.

Italy · 8 centers

Center list to be confirmed — check the primary protocol.

Brazil · 6 centers

• Instituto Lobus Unimed Volta Redonda — Volta Redonda
• Hospital Moinhos de Vento — Porto Alegre
• Newdata Clinical Trials — Aracaju
• CECIP - Centro de Estudos Clínicos do Interior Paulista — Jaú
• Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto
• Hospital Sírio-Libanês — São Paulo

Canada · 6 centers

• Barrie GI Associates — Barrie
• … and 5 more centers

Czechia · 5 centers

Center list to be confirmed — check the primary protocol.

Hungary · 5 centers

Center list to be confirmed — check the primary protocol.

Portugal · 5 centers

Center list to be confirmed — check the primary protocol.

South Korea · 5 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 5 centers

Center list to be confirmed — check the primary protocol.

Australia · 4 centers

• Macquarie University Hospital — Macquarie Park
• Coral Sea Clinical Research Institute — Mackay
• Footscray Hospital — Footscray
• Royal Melbourne Hospital — Parkville

Colombia · 4 centers

Center list to be confirmed — check the primary protocol.

Spain · 4 centers

Center list to be confirmed — check the primary protocol.

Belgium · 3 centers

• CHU St Pierre (St Pierre) — Brussels
• UZ Brussel — Brussels
• Cliniques Universitaires St-Luc — Brussels

Argentina · 2 centers

• Instituto Medico CER — Quilmes
• CICE 9 de Julio — San Miguel de Tucumán

Austria · 2 centers

• Ordensklinikum Linz Barmherzige Schwestern — Linz
• Klinikum Wels-Grieskirchen — Wels

Bulgaria · 2 centers

• Multiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology. — Panagyurishte
• MC " Sveti Ivan Rilski Chudotvorets- 2010 — Plovdiv

Chile · 2 centers

Center list to be confirmed — check the primary protocol.

Croatia · 2 centers

Center list to be confirmed — check the primary protocol.

Germany · 2 centers

Center list to be confirmed — check the primary protocol.

Israel · 2 centers

Center list to be confirmed — check the primary protocol.

Slovakia · 2 centers

Center list to be confirmed — check the primary protocol.

Romania · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06819891 · GA45332 · 2024-513054-30-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗