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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05910528

Acronym

TAHOE

Enrollment

Registered

2023-06-18

Start date

2023-07-24

Completion date

2026-12-31

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohns Disease

Keywords

Crohns Disease

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.

Interventions

DRUGAfimkibart

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

Belgium, France, Poland, United States

Contacts

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026