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

March 23, 2026 updated by: Hoffmann-La Roche

A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RO7790121 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Roeselare, Belgium, 8800
        • AZ Delta
  • France
      • Nantes, France, 44093
        • CHU de Nantes
      • Neuilly-sur-Seine, France, 92200
        • Institut des MICI, Clinique Ambroise Paré
      • Vandœuvre-lès-Nancy, France, 54500
        • CHRU de Nancy Brabois
  • Poland
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne
      • Warsaw, Poland, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut, LLC
    • Florida
      • Kissimmee, Florida, United States, 34741
        • I.H.S Health Northwell Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose
Drug: Afimkibart
Afimkibart will be administered during the Induction, Maintenance and OLE period.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121
Experimental: Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose
Drug: Afimkibart
Afimkibart will be administered during the Induction, Maintenance and OLE period.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Until end of study, approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Concentration (Ctrough)
Time Frame: Up to Week 64
Up to Week 64
Proportion of Participants Achieving Endoscopic Response
Time Frame: Week 14
Endoscopic response defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) >=50% from Baseline at Week 14
Week 14
Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI)
Time Frame: Week 14
Clinical remission defined as CDAI <150 at Week 14
Week 14
Proportion of Participants Achieving Clinical Remission by Patient Reported Outcome 2 (PRO2)
Time Frame: 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.
Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2023

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA45392
  • 2023-504265-23-00 (Ctis: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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