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

NCT06456593 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ABX464-202
• Study Type: interventional
• Target: 212
• Locations: 12 countries
• Sites: 149

Brief 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.

Conditions

Moderately to Severely Active Crohn Disease

Keywords

Crohn Disease

Outcome Measures

Primary Outcomes (13)

• Induction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI)

  Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 12 and Week 52 The CDAI total score ranges from 0 to over 600. Higher scores mean a worse outcome.

  Week 12 and week 52

• Maintenance Phase Efficacy - Simple Endoscopic Score for Crohn's disease (SES-CD)

  Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 52 The SES-CD is an endoscopic grading system that consists of a composite score based on 4 components: the size of mucosal ulcers, the extent of the ulcerated surface, the endoscopic extension, and the presence of stenosis (26). Each of the 4 SES-CD components are assessed in the 5 segments of the ileum and colon: ileum, right, transverse, left, and rectum. The SES-CD is the sum of the individual scores of each of the components across the 5 segments. The total score ranges from 0 to 60. Higher scores mean a worse outcome

  Week 52

• Maintenance Phase Efficacy - Endoscopic response

  Proportion of subjects with endoscopic response at Week 52

  Week 52

• Maintenance Phase Efficacy - SES-CD ulcer subscore > 1

  Proportion of subjects with no SES-CD ulcer subscore \> 1 in at least one segment at Week 52

  Week 52

• Maintenance Phase Efficacy - CDAI clinical remission

  Proportion of subjects with CDAI clinical remission at Week 52 Proportion of subjects with sustained CDAI clinical remission at Week 52

  Week 52

• Maintenance Phase Efficacy - PRO-2 clinical remission

  Proportion of subjects with patient reported outcome (PRO)-2 clinical remission at Week 52

  Week 52

• Maintenance Phase Efficacy - CDAI clinical response

  Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) at Week 52

  Week 52

• Maintenance Phase Efficacy - PRO-2 clinical response

  Proportion of subjects with PRO-2 clinical response (≥ 30% decrease in average daily PRO-2 score (AP + SF) and both no higher than baseline) at Week 52

  Week 52

• Maintenance Phase Efficacy - CDAI clinical response and endoscopic response

  Proportion of subjects with CDAI clinical response and endoscopic response at Week 52

  Week 52

• Maintenance Phase Efficacy - endoscopic remission

  Proportion of subjects with endoscopic remission at Week 52

  Week 52

• Extension Phase Safety- Adverse events

  Incidence of all treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and causally related TEAEs/SAEs Incidence of adverse events (AEs) leading to discontinuation

  Weeks 64, 76, 88,100 and EOS

• Extension Phase Safety - Hematology and coagulation

  Number of patients with clinically-significant abnormal laboratory parameters. Hematology: Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, platelet count, red blood cells; white blood cells Coagulation: International normalized ratio, activated partial thromboplastin time, fibrinogen, prothrombin time

  Weeks 64, 76, 88,100 and EOS

• Extension Phase Safety - Biochemistry

  Number of patients with clinically-significant abnormal laboratory parameters. Albumin, total protein, aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin, gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH), lipase, amylase, creatinine, creatinine clearance, urea, chloride, bicarbonate, sodium, potassium, calcium, phosphate, uric acid, glucose, total cholesterol, LDL cholesterol (direct), HDL cholesterol, triglycerides, creatine phosphokinase (CPK), high sensitivity troponin I and T, N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

  Weeks 64, 76, 88,100 and EOS

Secondary Outcomes (9)

• Induction Phase Efficacy - SES-CD

  Week 12

• Induction Phase Efficacy - Endoscopic response

  Week 12

• Induction Phase Efficacy-SES-CD ulcer subscore > 1

  Week 12

• Induction Phase Efficacy-CDAI clinical remission

  Week 12

• Induction Phase Efficacy-PRO-2 clinical remission

  Week 12

Study Arms (4)

Obefazimod 50mg

EXPERIMENTAL

Obefazimod 50mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)

Drug: Obefazimod

Obefazimod 25mg

EXPERIMENTAL

Obefazimod 25mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)

Drug: Obefazimod

Obefazimod 12.5mg

EXPERIMENTAL

Obefazimod 12.5mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)

Drug: Obefazimod

Placebo

PLACEBO COMPARATOR

Placebo given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)

Other: Placebo

Interventions

Obefazimod DRUG

Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).

Obefazimod 12.5mg; Obefazimod 25mg; Obefazimod 50mg

Placebo OTHER

Matching placebo will be administered QD in fed condition (ideally at the same time in the morning).

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able and willing to comply with study visits and procedures as per protocol.
• Confirmed and documented diagnosis of CD based on endoscopy and histology reports.
• 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).
• 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)
• 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.
• Subject should be affiliated to a health insurance policy whenever required by a participating country or state.
• Subject is able and willing to comply with usual public recommendations for sun protection.

You may not qualify if:

• 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.
• Current diagnosis of ulcerative colitis (UC) or indeterminate colitis
• CD without ileal and/or colonic involvement
• Symptomatic bowel stricture and/or stenosis not passable in endoscopy
• Related to CD surgery:
• Current stoma or ileoanal pouch
• More than 2 missing complete segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid and rectum
• Combined previous small bowel resections \> 100 cm
• Surgical bowel resection within the past 3 months prior to baseline
• Any other manifestation that might require surgery while enrolled in the study
• Related to CD treatments:
• Subject who is currently treated with prohibited concomitant therapies for CD as described in the study protocol
• Subject who has previously received natalizumab (or any other α4β1 integrin agonist)
• Subject who has failed more than three advanced therapies for the treatment of CD, or two different mechanisms of action for advanced therapies of CD
• History of, or active, malignancy including nonmelanoma skin cancer (subjects with a 5-year disease-free survival are eligible)

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (149)

IMC Gulf Coast Gastroenterology, PC

Fairhope, Alabama, 36532, United States

NOT YET RECRUITING

Scottsdale Gastroenterology Specialists

Scottsdale, Arizona, 85260, United States

NOT YET RECRUITING

GI Alliance -Gurnee

Sun City, Arizona, 85351, United States

RECRUITING

Hoag Hospital

Irvine, California, 92618, United States

NOT YET RECRUITING

United Medical Doctors

Murrieta, California, 92563, United States

RECRUITING

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

RECRUITING

Clinical Research Of Brandon, LLC

Brandon, Florida, 33511, United States

RECRUITING

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33762, United States

RECRUITING

Auzmer Research

Lakeland, Florida, 33813, United States

RECRUITING

Research Associates of South Florida, LLC

Miami, Florida, 33134, United States

RECRUITING

Wellness Clinical Research

Miami Lakes, Florida, 33016, United States

NOT YET RECRUITING

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653, United States

RECRUITING

Sarkis Clinical Trials - Parent

Ocala, Florida, 34474, United States

RECRUITING

Orlando Health, Inc.

Orlando, Florida, 32806, United States

RECRUITING

GCP Clinical Research, LLC

Tampa, Florida, 33609, United States

RECRUITING

Theia Clinical Research Centers, LLC

Temple Terrace, Florida, 33617, United States

RECRUITING

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Lucida Clinical Trials, LLC

New Bedford, Massachusetts, 02740, United States

RECRUITING

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

NOT YET RECRUITING

Henry Ford Columbus Center

Detroit, Michigan, 48202, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

NOT YET RECRUITING

OSU Inflammatory Bowel Disease Center

Hilliard, Ohio, 43026, United States

NOT YET RECRUITING

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110, United States

NOT YET RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401, United States

RECRUITING

Rapid City Medical Center, LLC

Rapid City, South Dakota, 57701, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

NOT YET RECRUITING

Central Texas Clinical Research, LLC

Austin, Texas, 78705, United States

NOT YET RECRUITING

Inquest Clinical Research

Baytown, Texas, 77521, United States

NOT YET RECRUITING

Novel Research, LLC

Bellaire, Texas, 77401, United States

RECRUITING

GI Alliance

Cedar Park, Texas, 78613, United States

RECRUITING

Baylor University Hospital

Dallas, Texas, 75246, United States

RECRUITING

GI Alliance - Garland

Garland, Texas, 75044, United States

NOT YET RECRUITING

Texas Digestive Specialists

Harlingen, Texas, 78550, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

NOT YET RECRUITING

GI Alliance - Gurnee

Mansfield, Texas, 76063, United States

NOT YET RECRUITING

Southern Star Research Institute, LLC

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

Richmond VA Medical Center

Richmond, Virginia, 23249, United States

NOT YET RECRUITING

Gastroenterology Consultants of Southwest Virginia.

Roanoke, Virginia, 24014, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

NOT YET RECRUITING

Hopital Universitaire de Bruxelles - Hopital Erasme

Brussels, Belgium

RECRUITING

AZ Maria Middelares

Ghent, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

Centre Wallonie Picarde

Tournai, Belgium

NOT YET RECRUITING

CHU UCL Namur

Yvoir, Belgium

RECRUITING

SurGal Clinic s.r.o.

Brno, Czechia

RECRUITING

Vojenska nemocnice Brno

Brno, Czechia

RECRUITING

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, Czechia

NOT YET RECRUITING

PreventaMed s.r.o.

Olomouc, Czechia

RECRUITING

ISCARE a.s.

Prague, Czechia

NOT YET RECRUITING

Nemocnice Slany

Slaný, Czechia

RECRUITING

CHU Amiens

Amiens, France

RECRUITING

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

NOT YET RECRUITING

CHU Clermont Ferrand - Hopital d'Estaing

Clermont-Ferrand, France

RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

CHU Dijon - Hôpital Bocage Central

Dijon, France

NOT YET RECRUITING

CHU de Grenoble - Hôpital Michallon

Grenoble, France

NOT YET RECRUITING

Centre Hospitalier Départemental Vendée - Les Oudairies

La Roche-sur-Yon, France

NOT YET RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

NOT YET RECRUITING

CHU Lille - Hôpital Claude Huriez

Lille, France

NOT YET RECRUITING

Hôpital Nord - CHU Marseille

Marseille, France

NOT YET RECRUITING

Hopital Saint Eloi

Montpellier, France

RECRUITING

CHU Nantes - Hôtel Dieu

Nantes, France

NOT YET RECRUITING

Institut des MICI

Neuilly-sur-Seine, France

RECRUITING

CHU Nice - Hôpital de l'Archet 2

Nice, France

NOT YET RECRUITING

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

RECRUITING

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, France

NOT YET RECRUITING

Hopital Rangueil

Toulouse, France

RECRUITING

Hôpital de Brabois

Vandœuvre-lès-Nancy, France

NOT YET RECRUITING

Charite-Campus Benjamin Franklin Medizin.Klin.I

Berlin, Germany

NOT YET RECRUITING

Krankenhaus Waldfriede e. V.

Berlin, Germany

RECRUITING

Universitaetsklinikum Brandenburg an der Havel

Brandenburg an der Havel, Germany

NOT YET RECRUITING

Universitaetsklinikum Erlangen

Erlangen, Germany

RECRUITING

Universitaetsklinikum Frankfurt Goethe-Universitaet

Frankfurt am Main, Germany

NOT YET RECRUITING

Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen

Hamburg, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, Germany

NOT YET RECRUITING

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Germany

RECRUITING

St. Marienkrankenhaus

Ludwigshafen, Germany

RECRUITING

LMU - Campus Grosshadern

München, Germany

NOT YET RECRUITING

Universitaetsklinikum Ulm

Ulm, Germany

RECRUITING

Bekes Varmegyei Kozponti Korhaz

Békéscsaba, Hungary

RECRUITING

Obudai Egeszsegugyi Centrum Kft.

Budapest, Hungary

NOT YET RECRUITING

Pannonia Maganorvosi Centrum

Budapest, Hungary

RECRUITING

Semmelweis Egyetem

Budapest, Hungary

RECRUITING

Semmelweis Egyetem

Budapest, Hungary

NOT YET RECRUITING

Gyongyosi Bugat Pal Korhaz

Gyöngyös, Hungary

NOT YET RECRUITING

Clinfan Szolgaltato Kft.

Szekszárd, Hungary

NOT YET RECRUITING

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, Hungary

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Renato Dulbecco di Catanzaro

Catanzaro, Italy

NOT YET RECRUITING

Ospedale San Raffaele

Milan, Italy

RECRUITING

Ospedale Sacro Cuore Don Calabria

Negrar, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

RECRUITING

Università Campus Bio-Medico di Roma

Roma, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Italy

RECRUITING

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

RECRUITING

Amsterdam UMC, Locatie AMC

Amsterdam, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Netherlands

NOT YET RECRUITING

Radboud UMC

Nijmegen, Netherlands

NOT YET RECRUITING

ETZ Elisabeth

Tilburg, Netherlands

RECRUITING

Bernhoven Uden

Uden, Netherlands

NOT YET RECRUITING

Centrum Medyczne Medis

Bydgoszcz, Poland

RECRUITING

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Poland

NOT YET RECRUITING

Santa Sp. z o.o. Sp. K Polimedica PTG Kielce

Kielce, Poland

NOT YET RECRUITING

Mz Badania Slowik Zymla Sp J

Knurów, Poland

RECRUITING

Centrum Medyczne Plejady

Krakow, Poland

RECRUITING

AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa

Lodz, Poland

RECRUITING

ALLMEDICA sp. z o. o.

Nowy Targ, Poland

RECRUITING

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, Poland

RECRUITING

Trialmed CRS

Piotrkow Trybunalski, Poland

NOT YET RECRUITING

NSZOZ Termedica - Centrum Badan Klinicznych

Poznan, Poland

NOT YET RECRUITING

SOLUMED Centrum Medyczne

Poznan, Poland

RECRUITING

Twoja Przychodnia PCM

Późna, Poland

RECRUITING

Gabinet Lekarski Bartosz Korczowski

Rzeszów, Poland

NOT YET RECRUITING

Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

Sosnowiec, Poland

RECRUITING

DC-MED

Swidnica, Poland

RECRUITING

Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

Szczecin, Poland

RECRUITING

Centrum Zdrowia MDM

Warsaw, Poland

RECRUITING

Medical Network Spolka z o.o

Warsaw, Poland

RECRUITING

NZOZ VIVAMED Jadwiga Miecz

Warsaw, Poland

RECRUITING

Melita Medical Sp. Z O. O.

Wroclaw, Poland

RECRUITING

ETG Zamosc

Zamość, Poland

NOT YET RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

Łęczna, Poland

RECRUITING

S.C Delta Health Care S.R.L

Bucharest, Romania

RECRUITING

SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie

Bucharest, Romania

RECRUITING

Spitalul Clinic Colentina

Bucharest, Romania

NOT YET RECRUITING

S.C Pelican Impex S.R.L

Oradea, Romania

NOT YET RECRUITING

Valahia Medical SRL

Ploieşti, Romania

RECRUITING

Fakultna nemocnica s poliklinikou F.D. Roosevelta

Banská Bystrica, Slovakia

RECRUITING

Cliniq s.r.o.

Bratislava, Slovakia

RECRUITING

Endomed, s.r.o.

Košice, Slovakia

RECRUITING

KM Management spol. s r.o.

Nitra, Slovakia

RECRUITING

Gastro I, s.r.o.

Prešov, Slovakia

RECRUITING

Penta hospitals SK, a.s.

Rimavská Sobota, Slovakia

RECRUITING

Centro Medico Teknon

Barcelona, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Spain

NOT YET RECRUITING

Hospital Universitario de Fuenlabrada

Fuenlabrada, Spain

NOT YET RECRUITING

Hospital General Juan Ramon Jimenez

Huelva, Spain

RECRUITING

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, Spain

RECRUITING

Clinica Gaias - Santiago

Santiago de Compostela, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Spain

NOT YET RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Study Director

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 13, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

ES (8); BE (6); SL (6); FR (19); DE (12); IT (9); CZ (6); US (43); NL (5); PL (22); RO (5); HU (8)