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

Phase 2Active Not RecruitingNCT05910528

Hoffmann-La Roche21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Crohns Disease

Interventions

AfimkibartDRUG

Afimkibart will be administered during the Induction, Maintenance and OLE period.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderately to severely active CD as defined by CDAI and 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 Exclusion Criteria: * Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease * Short gut syndrome * Presence of an ostomy or ileoanal pouch * Bowel resection or diversion with \~6-months

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

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation

Time frame: Until end of study, approximately 5 years

Secondary Outcomes

Proportion of Participants Achieving Endoscopic Response

Endoscopic response defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \>=50% from Baseline at Week 14

Time frame: Week 14

Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI)

Clinical remission defined as CDAI \<150 at Week 14

Time frame: Week 14

Proportion of Participants Achieving Clinical Remission by Patient Reported Outcome 2 (PRO2)

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.

Time frame: Week 14

Trough Concentration (Ctrough)

Time frame: Up to Week 64

Data from ClinicalTrials.gov

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