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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06456593

Public ClinicalTrials.gov record NCT06456593. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 1, 2026, 10:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06456593
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Abivax S.A.
Industry
Enrollment
212 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 30, 2024 (Actual)
Primary completion
Dec 2026 (Estimated)
Completion
Apr 2028 (Estimated)
Last update posted
Apr 27, 2026

2024 – 2028

United States locations

U.S. sites
43
U.S. states
18
U.S. cities
43
Facility City State ZIP Site status
IMC Gulf Coast Gastroenterology, PC Fairhope Alabama 36532 Not yet recruiting
Scottsdale Gastroenterology Specialists Scottsdale Arizona 85260 Not yet recruiting
GI Alliance -Gurnee Sun City Arizona 85351 Recruiting
Hoag Hospital Irvine California 92618 Not yet recruiting
United Medical Doctors Murrieta California 92563 Recruiting
Peak Gastroenterology Associates Colorado Springs Colorado 80907 Recruiting
Clinical Research Of Brandon, LLC Brandon Florida 33511 Recruiting
West Central Gastroenterology d/b/a Gastro Florida Clearwater Florida 33762 Recruiting
Auzmer Research Lakeland Florida 33813 Recruiting
Research Associates of South Florida, LLC Miami Florida 33134 Recruiting
Wellness Clinical Research Miami Lakes Florida 33016 Not yet recruiting
Advanced Research Institute, Inc. New Port Richey Florida 34653 Recruiting
Sarkis Clinical Trials - Parent Ocala Florida 34474 Recruiting
Orlando Health, Inc. Orlando Florida 32806 Recruiting
GCP Clinical Research, LLC Tampa Florida 33609 Recruiting
Theia Clinical Research Centers, LLC Temple Terrace Florida 33617 Recruiting
Northwestern University Evanston Illinois 60208 Recruiting
University of Iowa Health Care Iowa City Iowa 52242 Not yet recruiting
Lucida Clinical Trials, LLC New Bedford Massachusetts 02740 Recruiting
University of Massachusetts, Worcester Worcester Massachusetts 01655 Not yet recruiting
Henry Ford Columbus Center Detroit Michigan 48202 Recruiting
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756 Not yet recruiting
OSU Inflammatory Bowel Disease Center Hilliard Ohio 43026 Not yet recruiting
Susquehanna Research Group, LLC Harrisburg Pennsylvania 17110 Not yet recruiting
UPMC Pittsburgh Pennsylvania 15213 Not yet recruiting
Frontier Clinical Research, LLC Uniontown Pennsylvania 15401 Recruiting
Rapid City Medical Center, LLC Rapid City South Dakota 57701 Recruiting
Vanderbilt University Medical Center Nashville Tennessee 37212 Not yet recruiting
Central Texas Clinical Research, LLC Austin Texas 78705 Not yet recruiting
Inquest Clinical Research Baytown Texas 77521 Not yet recruiting
Novel Research, LLC Bellaire Texas 77401 Recruiting
GI Alliance Cedar Park Texas 78613 Recruiting
Baylor University Hospital Dallas Texas 75246 Recruiting
GI Alliance - Garland Garland Texas 75044 Not yet recruiting
Texas Digestive Specialists Harlingen Texas 78550 Recruiting
Houston Methodist Hospital Houston Texas 77030 Not yet recruiting
GI Alliance - Gurnee Mansfield Texas 76063 Not yet recruiting
Southern Star Research Institute, LLC San Antonio Texas 78229 Not yet recruiting
Tyler Research Institute, LLC Tyler Texas 75701 Recruiting
University of Utah Salt Lake City Utah 84108 Recruiting
Richmond VA Medical Center Richmond Virginia 23249 Not yet recruiting
Gastroenterology Consultants of Southwest Virginia. Roanoke Virginia 24014 Recruiting
University of Washington Seattle Washington 98195 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 105 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06456593, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 27, 2026 · Synced Oct 1, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06456593 live on ClinicalTrials.gov.

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