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RECRUITINGPHASE2

Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

NCT06456593•Abivax S.A.

View on ClinicalTrials.gov

Summary

This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female (at birth) 18 to 75 years old and able to understand, sign, and date the written voluntary informed consent at the visit prior to any protocol-specified procedures
•2. Able and willing to comply with study visits and procedures as per protocol.
•3. Confirmed and documented diagnosis of CD based on endoscopy and histology reports.
•4. Moderately to severely active CD as defined by 220 ≤ CDAI ≤ 450 and SES-CD ≥ 6 for ileo-colonic or colonic disease or SES-CD ≥ 4 for isolated ileal disease (per central reading).
•5. Documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids (CS), immunosuppressants (IS), biologic or biosimilar therapies, or janus kinase (JAK) (note: failure to only 5-aminosalicylic acid \[5-ASA\] is not accepted)
•6. Women of childbearing potential (WOCBP) and male subjects with WOCBP partner must agree to comply with contraception requirements as stated in section 4.5 (contraception) of this protocol.
•7. Subject should be affiliated to a health insurance policy whenever required by a participating country or state.
•8. Subject is able and willing to comply with usual public recommendations for sun protection.

Exclusion Criteria

•1. WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study; or male subject with WOCBP partner who intends to be pregnant during the study.
•2. Current diagnosis of ulcerative colitis (UC) or indeterminate colitis
•3. CD without ileal and/or colonic involvement
•4. Untreated active external or perianal fistula or abscess. Stable fistula without abscess and with minimal or low drainage may be enrolled. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before screening colonoscopy or 8 weeks before screening colonoscopy for intra-abdominal abscesses, if no additional surgery is anticipated.
•5. Symptomatic bowel stricture and/or stenosis not passable in endoscopy
•6. Related to CD surgery:
•1. Current stoma or ileoanal pouch
•2. More than 2 missing complete segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid and rectum
•3. Combined previous small bowel resections \> 100 cm
•4. Surgical bowel resection within the past 3 months prior to baseline
+37 more criteria

Locations (149)

IMC Gulf Coast Gastroenterology, PC

Fairhope, Alabama, United States

Scottsdale Gastroenterology Specialists

Scottsdale, Arizona, United States

GI Alliance -Gurnee

Sun City, Arizona, United States

Hoag Hospital

Irvine, California, United States

United Medical Doctors

Murrieta, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Clinical Research Of Brandon, LLC

Brandon, Florida, United States

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, United States

Auzmer Research

Lakeland, Florida, United States

Research Associates of South Florida, LLC

Miami, Florida, United States

Key Dates

Start Date

October 30, 2024

Primary Completion Date

December 1, 2026

Completion Date

April 1, 2028

Last Updated

September 18, 2025

Enrollment

212

ESTIMATED participants

Conditions

Moderately to Severely Active Crohn Disease

Interventions

Obefazimod

DRUG

Placebo

OTHER

Contacts

Study Director

CONTACT

+33 (0) 1 53 83 09 63 info@abivax.com