A phase 2, multicenter, double-blind, two-arm study of subcutaneous RVT-3101 for the treatment of subjects with moderate to severe active crohn’s disease

Phase 1

Recruiting

• Conditions: Crohn's disease; MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-504265-23-00
• Lead Sponsor: Telavant Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analysis., Participants of any gender-definition, aged 18-75 years (or at age of consent per local guidelines if =18 years)., Must have confirmed diagnosis of ileal, ileocolonic or colonic CD for at least 12 weeks (approximately 3 months) prior to the Baseline (W1, D1) Visit. Appropriate documentation of biopsy-proven CD must be available and recorded., CDAI score 220-450 determined at Screening, CDAI to be assessed prior to Screening colonoscopy.

Exclusion Criteria

Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease., For prohibited medications and exceptions please see Section 8.7 of the protocol., Presence of an ostomy or ileoanal pouch., Bowel resection or diversion within approximately 6 months prior to the Baseline (W1, D1) Visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified