NCT05910528

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
57mo left

Started Jul 2023

Longer than P75 for phase_2

Geographic Reach
4 countries

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jul 2023Dec 2030

First Submitted

Initial submission to the registry

June 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

7.4 years

First QC Date

June 9, 2023

Last Update Submit

March 23, 2026

Conditions

Crohns Disease

Keywords

Crohns Disease

Outcome Measures

Primary Outcomes (1)

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

    Until end of study, approximately 5 years

Secondary Outcomes (4)

  • Proportion of Participants Achieving Endoscopic Response

    Week 14

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

    Week 14

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

    Week 14

  • Trough Concentration (Ctrough)

    Up to Week 64

Study Arms (2)

Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose

EXPERIMENTAL
Drug: Afimkibart

Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose

EXPERIMENTAL
Drug: Afimkibart

Interventions

AfimkibartDRUG

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

Also known as: RO7790121, RVT-3101, PF-06480605
Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE doseTreatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Digestive Health Specialists

Dothan, Alabama, 36305, United States

Location

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

I.H.S Health Northwell Health

Kissimmee, Florida, 34741, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

AZ Delta

Roeselare, 8800, Belgium

Location

CHU de Nantes

Nantes, 44093, France

Location

Institut des MICI, Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

CHRU de Nancy Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728, Poland

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 18, 2023

Study Start

July 24, 2023

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Locations

PL(2)FR(3)US(5)BE(1)