Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease

Phase 2

Active, not recruiting

• Conditions: Crohns Disease
• Interventions: Drug: Afimkibart

• Registration Number: NCT05910528
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Study Start: 2023-07-24
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-29
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Moderately to severely active CD as defined by Crohn's Disease Activity Index (CDAI) and Simple Endoscopic Score for CD (SES-CD), assessed by central read
• Elevated very soft or liquid stool frequency and/or abdominal pain
• Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy
• Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease

Exclusion Criteria

• Short gut syndrome
• Presence of an ostomy or ileoanal pouch
• Bowel resection or diversion with ~6-months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose	Afimkibart	-
Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose	Afimkibart	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation	Until end of study, approximately 5 years

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving Endoscopic Response	Week 14	Endoscopic response defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \>=50% from Baseline at Week 14
Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI)	Week 14	Clinical remission defined as CDAI \<150 at Week 14
Proportion of Participants Achieving Clinical Remission by Patient Reported Outcome 2 (PRO2)	Week 14	Clinical remission by PRO2 defined as average daily very soft or liquid stool frequency (SF) \<= 2.8 and abdominal pain (AP) score \<=1, and not worse than Baseline at Week 14.
Trough Concentration (Ctrough)	Up to Week 64

Trial Locations

Locations (11)

Digestive Health Specialists; 🇺🇸 Dothan, Alabama, United States

Medical Research Center of Connecticut, LLC; 🇺🇸 Hamden, Connecticut, United States

I.H.S Health Northwell Health; 🇺🇸 Kissimmee, Florida, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Clinical Research Institute of Michigan; 🇺🇸 Chesterfield, Michigan, United States

AZ Delta; 🇧🇪 Roeselare, Belgium

CHU de Nantes; 🇫🇷 Nantes, France

Institut des MICI, Clinique Ambroise Paré; 🇫🇷 Neuilly-sur-Seine, France

CHRU de Nancy Brabois; 🇫🇷 Vandœuvre-lès-Nancy, France

Twoja Przychodnia-Szczecinskie Centrum Medyczne; 🇵🇱 Szczecin, Poland

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