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NCT Number: NCT05910528

Afimkibart (RO7790121) for the Treatment of 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohns Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AZ Delta, Roeselare, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Afimkibart

Drug

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

Other names: RO7790121, RVT-3101, PF-06480605

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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.

  4. Trough Concentration (Ctrough)

    Time frame: Up to Week 64

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: TAHOE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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