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

Part of paid clinical trials in Fairhope, Alabama.

Sponsor: Abivax S.A.
Study ID: NCT06456593
Phase: PHASE2
Status: Recruiting

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Conditions

Moderately to Severely Active Crohn Disease

Eligibility Criteria

Sex: ALL
Age: 18 Years - 75 Years
Healthy Volunteers: Not accepted

Interventions

Obefazimod — DRUG
Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).
Placebo — OTHER
Matching placebo will be administered QD in fed condition (ideally at the same time in the morning).

Study Details

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.

Key Dates

Start date: Oct 30, 2024
Status verified: Apr 2026
Primary completion: Dec 31, 2026
Completion: Apr 30, 2028

Study Design

Enrollment: 212 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Obefazimod 50mg
Obefazimod 50mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Experimental: Obefazimod 25mg
Obefazimod 25mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Experimental: Obefazimod 12.5mg
Obefazimod 12.5mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Placebo Comparator: Placebo
Placebo given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)

Primary Outcome Measure

Induction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI) [ Time Frame: Week 12 and week 52 ]

Central Contacts

Study Director
+33 (0) 1 53 83 09 63
[email protected]

Locations (43)

Facility	City	State	ZIP	Site coordinators
IMC Gulf Coast Gastroenterology, PC	Fairhope	Alabama	36532	Nathaniel Winstead, MD
Scottsdale Gastroenterology Specialists	Scottsdale	Arizona	85260	S. Jaffrey Kazi, MD
GI Alliance -Gurnee	Sun City	Arizona	85351	Chirag Trivedi, MD
Hoag Hospital	Irvine	California	92618	Caroline Hwang, MD
United Medical Doctors	Murrieta	California	92563	John Hong, MD
Peak Gastroenterology Associates	Colorado Springs	Colorado	80907	Bhaktasharan Patel, MD
Clinical Research Of Brandon, LLC	Brandon	Florida	33511	German Alvarez, MD
West Central Gastroenterology d/b/a Gastro Florida	Clearwater	Florida	33762	Tejinder Glamour, MD
Auzmer Research	Lakeland	Florida	33813	Niaz Ausaf, MD
Research Associates of South Florida, LLC	Miami	Florida	33134	Alexander Veloso, MD
Wellness Clinical Research	Miami Lakes	Florida	33016	Lucky Flores, MD
Advanced Research Institute, Inc.	New Port Richey	Florida	34653	Curtis Freedland, MD
Sarkis Clinical Trials - Parent	Ocala	Florida	34474	Vishnu Reddy, MD
Orlando Health, Inc.	Orlando	Florida	32806	Udayakumar Navaneethan, MD
GCP Clinical Research, LLC	Tampa	Florida	33609	Alan Weintraub, MD
Theia Clinical Research Centers, LLC	Temple Terrace	Florida	33617	Zubair Farooqui, MD
Northwestern University	Evanston	Illinois	60208	Emanelle Bellaguarda, MD
University of Iowa Health Care	Iowa City	Iowa	52242	Steven Polyak, MD
Lucida Clinical Trials, LLC	New Bedford	Massachusetts	02740	Jason Reich, MD
University of Massachusetts, Worcester	Worcester	Massachusetts	01655	Abbas Rupawala, MD
Henry Ford Columbus Center	Detroit	Michigan	48202	Najwa El-Nachef, MD
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	03756	Corey Siegel, MD
OSU Inflammatory Bowel Disease Center	Hilliard	Ohio	43026	Madalina Butnariu, MD
Susquehanna Research Group, LLC	Harrisburg	Pennsylvania	17110	Adnan Ahmad, MD
UPMC	Pittsburgh	Pennsylvania	15213	Marc Schwartz, MD
Frontier Clinical Research, LLC	Uniontown	Pennsylvania	15401	Marc Happe, MD
Rapid City Medical Center, LLC	Rapid City	South Dakota	57701	Blake Jones, MD
Vanderbilt University Medical Center	Nashville	Tennessee	37212	Audrey Bennett, MD
Central Texas Clinical Research, LLC	Austin	Texas	78705	Cynthia Brinson, MD
Inquest Clinical Research	Baytown	Texas	77521	Haider Afzal, MD
Novel Research, LLC	Bellaire	Texas	77401	Moazzam Sana, MD
GI Alliance	Cedar Park	Texas	78613	Ryan Cho, MD
Baylor University Hospital	Dallas	Texas	75246	Themistocles Dassopoulos, MD
GI Alliance - Garland	Garland	Texas	75044	Harry Sarles, MD
Texas Digestive Specialists	Harlingen	Texas	78550	Nolan Perez, MD
Houston Methodist Hospital	Houston	Texas	77030	Bincy Abraham, MD
GI Alliance - Gurnee	Mansfield	Texas	76063	Moustafa Youssef, MD
Southern Star Research Institute, LLC	San Antonio	Texas	78229	Jeff Bullock, MD
Tyler Research Institute, LLC	Tyler	Texas	75701	George Aaron DuVall, MD
University of Utah	Salt Lake City	Utah	84108	John Valentine, MD
Richmond VA Medical Center	Richmond	Virginia	23249	William Pandak, MD
Gastroenterology Consultants of Southwest Virginia.	Roanoke	Virginia	24014	Nirish Shah, MD
University of Washington	Seattle	Washington	98195	Scott Lee, MD

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