Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease (ENHANCE-CD)

April 22, 2026 updated by: Abivax S.A.

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

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 Overview

Status

Recruiting

Conditions

Moderately to Severely Active Crohn Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

212

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Study Director
Phone Number: +33 (0) 1 53 83 09 63
Email: info@abivax.com

Study Locations

Belgium
- - Brussels, Belgium
    - Recruiting
    - Hopital Universitaire de Bruxelles - Hopital Erasme
    - Contact:
      
      Denis Franchimont, MD
  - Ghent, Belgium
    - Recruiting
    - AZ Maria Middelares
    - Contact:
      
      Nele Deprez, MD
  - Ghent, Belgium
    - Not yet recruiting
    - Universitair Ziekenhuis Gent
    - Contact:
      
      Triana Lobaton Ortega, MD
  - Leuven, Belgium
    - Recruiting
    - UZ Leuven
    - Contact:
      
      Bram Verstockt, MD
  - Tournai, Belgium
    - Not yet recruiting
    - Centre Wallonie Picarde
    - Contact:
      
      Lena Capirchio, MD
  - Yvoir, Belgium
    - Recruiting
    - CHU UCL Namur
    - Contact:
      
      Jean-François Rahier, MD
Czechia
- - Brno, Czechia
    - Recruiting
    - Vojenska nemocnice Brno
    - Contact:
      
      David Stepek, MD
  - Brno, Czechia
    - Recruiting
    - SurGal clinic s.r.o.
    - Contact:
      
      Jan Ulbrych, MD
  - Hradec Králové, Czechia
    - Not yet recruiting
    - Hepato-Gastroenterologie HK s.r.o.
    - Contact:
      
      Miroslava Volfova, MD
  - Olomouc, Czechia
    - Recruiting
    - PreventaMed s.r.o.
    - Contact:
      
      Jiri Pumprla, MD
  - Prague, Czechia
    - Not yet recruiting
    - ISCARE a.s.
    - Contact:
      
      Milan Lukas, MD
  - Slaný, Czechia
    - Recruiting
    - Nemocnice Slany
    - Contact:
      
      Martin Peterka, MD
France
- - Amiens, France
    - Recruiting
    - CHU Amiens
    - Contact:
      
      Mathurin Fumery, MD
  - Besançon, France
    - Not yet recruiting
    - CHU Besançon - Hôpital Jean Minjoz
    - Contact:
      
      Lucine Vuitton, MD
  - Clermont-Ferrand, France
    - Recruiting
    - CHU Clermont Ferrand - Hôpital d'Estaing
    - Contact:
      
      Anthony Buisson, MD
  - Créteil, France
    - Recruiting
    - Hôpital Henri Mondor
    - Contact:
      
      Mathieu UZZAN, MD
  - Dijon, France
    - Not yet recruiting
    - CHU Dijon - Hôpital Bocage Central
    - Contact:
      
      Maeva Charkaoui, MD
  - Grenoble, France
    - Not yet recruiting
    - CHU de Grenoble - Hôpital Michallon
    - Contact:
      
      Marianne Hupe, MD
  - La Roche-sur-Yon, France
    - Not yet recruiting
    - Centre Hospitalier Départemental Vendée - Les Oudairies
    - Contact:
      
      Morgane Amil, MD
  - Le Kremlin-Bicêtre, France
    - Not yet recruiting
    - Hôpital Bicêtre
    - Contact:
      
      Aurelien Amiot, MD
  - Lille, France
    - Not yet recruiting
    - CHU Lille - Hôpital Claude Huriez
    - Contact:
      
      Maria Nachury, MD
  - Marseille, France
    - Not yet recruiting
    - Hopital Nord - CHU Marseille
    - Contact:
      
      Mélanie SERRERO, MD
  - Montpellier, France
    - Recruiting
    - Hopital Saint Eloi
    - Contact:
      
      Romain Altwegg, MD
  - Nantes, France
    - Not yet recruiting
    - CHU Nantes - Hotel Dieu
    - Contact:
      
      Catherine Le Berre, MD
  - Neuilly-sur-Seine, France
    - Recruiting
    - Institut des MICI
    - Contact:
      
      Xavier Treton, MD
  - Nice, France
    - Not yet recruiting
    - CHU Nice - Hopital de l'Archet 2
    - Contact:
      
      Adrien Nicolau, MD
  - Pessac, France
    - Recruiting
    - CHU Bordeaux - Hôpital Haut-Lévêque
    - Contact:
      
      David Laharie, MD
  - Pierre-Bénite, France
    - Recruiting
    - Centre Hospitalier Lyon Sud
    - Contact:
      
      Stephane Nancey, MD
  - Saint-Etienne, France
    - Not yet recruiting
    - CHU Saint Etienne - Hôpital Nord
    - Contact:
      
      Xavier Roblin, MD
  - Toulouse, France
    - Recruiting
    - Hôpital Rangueil
    - Contact:
      
      Cyrielle Gilletta de Saint Joseph, MD
  - Vandœuvre-lès-Nancy, France
    - Not yet recruiting
    - Hôpital de Brabois
    - Contact:
      
      Benedicte Caron, MD
Germany
- - Berlin, Germany
    - Not yet recruiting
    - Charite-Campus Benjamin Franklin Medizin.Klin.I
    - Contact:
      
      Britta Siegmund, MD
  - Berlin, Germany
    - Recruiting
    - Krankenhaus Waldfriede e. V.
    - Contact:
      
      Carsten Buening, MD
  - Brandenburg an der Havel, Germany
    - Not yet recruiting
    - Universitaetsklinikum Brandenburg an der Havel
    - Contact:
      
      Stefan Lueth, MD
  - Erlangen, Germany
    - Recruiting
    - Universitaetsklinikum Erlangen
    - Contact:
      
      Raja Atreya, MD
  - Frankfurt am Main, Germany
    - Not yet recruiting
    - Universitaetsklinikum Frankfurt Goethe-Universitaet
    - Contact:
      
      Irina Blumenstein
  - Hamburg, Germany
    - Recruiting
    - Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen
    - Contact:
      
      Stefanie Howaldt, MD
  - Hanover, Germany
    - Recruiting
    - Medizinische Hochschule Hannover
    - Contact:
      
      Ursula Seidler, MD
  - Heidelberg, Germany
    - Not yet recruiting
    - Universitaetsklinikum Heidelberg
    - Contact:
      
      Annika Gauss, MD
  - Kiel, Germany
    - Recruiting
    - Universitaetsklinikum Schleswig-Holstein - Campus Kiel
    - Contact:
      
      Stefan Schreiber, MD
  - Ludwigshafen, Germany
    - Recruiting
    - St. Marienkrankenhaus
    - Contact:
      
      Tanja Kuehbacher, MD
  - München, Germany
    - Not yet recruiting
    - LMU - Campus Grosshadern
    - Contact:
      
      Helga Toeroek, MD
  - Ulm, Germany
    - Recruiting
    - Universitaetsklinikum Ulm
    - Contact:
      
      Jochen Klaus, MD
Hungary
- - Budapest, Hungary
    - Recruiting
    - Semmelweis Egyetem
    - Contact:
      
      Pal Miheller, MD
  - Budapest, Hungary
    - Not yet recruiting
    - Semmelweis Egyetem
    - Contact:
      
      Zsolt Tulassay, MD
  - Budapest, Hungary
    - Recruiting
    - Pannónia Magánorvosi Centrum
    - Contact:
      
      Robert Schnabel, MD
  - Budapest, Hungary
    - Not yet recruiting
    - Obudai Egeszsegugyi Centrum Kft.
    - Contact:
      
      Robert Sike, MD
  - Békéscsaba, Hungary
    - Recruiting
    - Bekes Varmegyei Kozponti Korhaz
    - Contact:
      
      Marta Varga, MD
  - Gyöngyös, Hungary
    - Not yet recruiting
    - Gyongyosi Bugat Pal Korhaz
    - Contact:
      
      Gabor Makai, MD
  - Szekszárd, Hungary
    - Not yet recruiting
    - Clinfan Szolgaltato Kft.
    - Contact:
      
      Agnes Salamon, MD
  - Székesfehérvár, Hungary
    - Recruiting
    - Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
    - Contact:
      
      Roland Fejes, MD
Italy
- - Bologna, Italy
    - Not yet recruiting
    - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
    - Contact:
      
      Paolo Gionchetti, MD
  - Catanzaro, Italy
    - Not yet recruiting
    - Azienda Ospedaliera Universitaria Renato Dulbecco di Catanzaro
    - Contact:
      
      Francesco Luzza, MD
  - Milan, Italy
    - Recruiting
    - Ospedale San Raffaele
    - Contact:
      
      Silvio Danese, MD
  - Negrar, Italy
    - Not yet recruiting
    - Ospedale Sacro Cuore Don Calabria
    - Contact:
      
      Angela Variola, MD
  - Pavia, Italy
    - Recruiting
    - Fondazione IRCCS Policlinico San Matteo
    - Contact:
      
      Antonio Di Sabatino, MD
  - Roma, Italy
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    - Contact:
      
      Antonio Gasbarrini, MD
  - Roma, Italy
    - Recruiting
    - Università Campus Bio-Medico di Roma
    - Contact:
      
      Michele Cicala, MD
  - Rozzano, Italy
    - Recruiting
    - Istituto Clinico Humanitas
    - Contact:
      
      Alessandro Armuzzi, MD
  - San Giovanni Rotondo, Italy
    - Recruiting
    - IRCCS Ospedale Casa Sollievo della Sofferenza
    - Contact:
      
      Fabrizio Bossa, MD
Netherlands
- - Amsterdam, Netherlands
    - Recruiting
    - Amsterdam UMC, locatie AMC
    - Contact:
      
      Geert D'Haens, MD
  - Maastricht, Netherlands
    - Not yet recruiting
    - Maastricht University Medical Center
    - Contact:
      
      Marieke Pierik, MD
  - Nijmegen, Netherlands
    - Not yet recruiting
    - Radboud UMC
    - Contact:
      
      Marjolijn Duijvestein, MD
  - Tilburg, Netherlands
    - Recruiting
    - ETZ Elisabeth
    - Contact:
      
      Maurice Lutgens, MD
  - Uden, Netherlands
    - Not yet recruiting
    - Bernhoven Uden
    - Contact:
      
      Moniek Gorter, MD
Poland
- - Bydgoszcz, Poland
    - Not yet recruiting
    - NZOZ Centrum Medyczne KERmed
    - Contact:
      
      Patryk Korga, MD
  - Bydgoszcz, Poland
    - Recruiting
    - Centrum Medyczne Medis
    - Contact:
      
      Maria Klopocka, MD
  - Kielce, Poland
    - Not yet recruiting
    - Santa Sp. z o.o. Sp. K Polimedica PTG Kielce
    - Contact:
      
      Dariusz Solowiej, MD
  - Knurów, Poland
    - Recruiting
    - Mz Badania Slowik Zymla Sp J
    - Contact:
      
      Maciej Zymla, MD
  - Krakow, Poland
    - Recruiting
    - Centrum Medyczne Plejady
    - Contact:
      
      Monika Augustyn, MD
  - Lodz, Poland
    - Recruiting
    - AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa
    - Contact:
      
      Rafal Drozda, MD
  - Nowy Targ, Poland
    - Recruiting
    - ALLMEDICA sp. z o. o.
    - Contact:
      
      Mikolaj Krzyzanowski, MD
  - Opole, Poland
    - Recruiting
    - Twoja Przychodnia Opolskie Centrum Medyczne
    - Contact:
      
      Marzena Kwinto, MD
  - Piotrkow Trybunalski, Poland
    - Not yet recruiting
    - Trialmed CRS
    - Contact:
      
      Beata Neneman, MD
  - Poznan, Poland
    - Not yet recruiting
    - NSZOZ Termedica - Centrum Badan Klinicznych
    - Contact:
      
      Jacek Paszkowski, MD
  - Poznan, Poland
    - Recruiting
    - Solumed Centrum Medyczne
    - Contact:
      
      Magdalena Andrzejewska, MD
  - Późna, Poland
    - Recruiting
    - Twoja Przychodnia PCM
    - Contact:
      
      Ewa Furmanowska-Ladorska, MD
  - Rzeszów, Poland
    - Not yet recruiting
    - Gabinet Lekarski Bartosz Korczowski
    - Contact:
      
      Bartosz Korczowski, MD
  - Sosnowiec, Poland
    - Recruiting
    - Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
    - Contact:
      
      Lukasz Firkowski, MD
  - Swidnica, Poland
    - Recruiting
    - DC-MED
    - Contact:
      
      Witold Marczynski, MD
  - Szczecin, Poland
    - Recruiting
    - Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
    - Contact:
      
      Beata Gawdis Wojnarska, MD
  - Warsaw, Poland
    - Recruiting
    - Centrum Zdrowia MDM
    - Contact:
      
      Marek Woynarowski, MD
  - Warsaw, Poland
    - Recruiting
    - Medical Network Spolka z o.o
    - Contact:
      
      Jaroslaw Kierkus, MD
  - Warsaw, Poland
    - Recruiting
    - NZOZ VIVAMED Jadwiga Miecz
    - Contact:
      
      Robert Petryka, MD
  - Wroclaw, Poland
    - Recruiting
    - Melita Medical Sp. Z O. O.
    - Contact:
      
      Jaroslaw Leszczyszyn, MD
  - Zamość, Poland
    - Not yet recruiting
    - ETG Zamosc
    - Contact:
      
      Katarzyna Wojcik, MD
  - Łęczna, Poland
    - Recruiting
    - Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej
    - Contact:
      
      Lukasz Wolanski, MD
Romania
- - Bucharest, Romania
    - Not yet recruiting
    - Spitalul Clinic Colentina
    - Contact:
      
      Radu-Bogdan Mateescu, MD
  - Bucharest, Romania
    - Recruiting
    - S.C Delta Health Care S.R.L
    - Contact:
      
      Camelia Chioncel, MD
  - Bucharest, Romania
    - Recruiting
    - SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
    - Contact:
      
      Theodor Alexandru Voiosu, MD
  - Oradea, Romania
    - Not yet recruiting
    - S.C Pelican Impex S.R.L
    - Contact:
      
      Alin-Horea Suta, MD
  - Ploieşti, Romania
    - Recruiting
    - Valahia Medical SRL
    - Contact:
      
      George Stancu, MD
Slovakia
- - Banská Bystrica, Slovakia
    - Recruiting
    - Fakultna nemocnica s poliklinikou F.D. Roosevelta
    - Contact:
      
      Jozef Balaz, MD
  - Bratislava, Slovakia
    - Recruiting
    - Cliniq s.r.o.
    - Contact:
      
      Tibor Hlavaty, MD
  - Košice, Slovakia
    - Recruiting
    - Endomed, s.r.o.
    - Contact:
      
      Miroslav Fedurco, MD
  - Nitra, Slovakia
    - Recruiting
    - KM Management spol. s r.o.
    - Contact:
      
      Milos Gregus, MD
  - Prešov, Slovakia
    - Recruiting
    - Gastro I, s.r.o.
    - Contact:
      
      Bohus Bunganic, MD
  - Rimavská Sobota, Slovakia
    - Recruiting
    - Penta hospitals SK, a.s.
    - Contact:
      
      Jan Zachar, MD
Spain
- - Barcelona, Spain
    - Recruiting
    - Centro Medico Teknon
    - Contact:
      
      Miquel Sans Cuffi, MD
  - Córdoba, Spain
    - Not yet recruiting
    - Hospital Universitario Reina Sofia
    - Contact:
      
      Eva Maria Iglesias Flores
  - Fuenlabrada, Spain
    - Not yet recruiting
    - Hospital Universitario de Fuenlabrada
    - Contact:
      
      Fernando Bermejo San Jose, MD
  - Huelva, Spain
    - Recruiting
    - Hospital General Juan Ramon Jimenez
    - Contact:
      
      Elena Gomez Delgado, MD
  - Las Palmas de Gran Canaria, Spain
    - Recruiting
    - Hospital Universitario de Gran Canaria Dr. Negrin
    - Contact:
      
      Daniel Sebastian Ceballos Santos, MD
  - Santiago de Compostela, Spain
    - Recruiting
    - Clínica Gaias - Santiago
    - Contact:
      
      Ana Alvarez Castro, MD
  - Seville, Spain
    - Not yet recruiting
    - Hospital Universitario Virgen del Rocio
    - Contact:
      
      Eduardo Leo Carnerero, MD
  - Valencia, Spain
    - Not yet recruiting
    - Hospital Clinico Universitario de Valencia
    - Contact:
      
      Carles Suria Bolufer, MD
United States
- Alabama
  - Fairhope, Alabama, United States, 36532
    - Not yet recruiting
    - IMC Gulf Coast Gastroenterology, PC
    - Contact:
      
      Nathaniel Winstead, MD
- Arizona
  - Scottsdale, Arizona, United States, 85260
    - Not yet recruiting
    - Scottsdale Gastroenterology Specialists
    - Contact:
      
      S. Jaffrey Kazi, MD
  - Sun City, Arizona, United States, 85351
    - Recruiting
    - GI Alliance -Gurnee
    - Contact:
      
      Chirag Trivedi, MD
- California
  - Irvine, California, United States, 92618
    - Not yet recruiting
    - Hoag Hospital
    - Contact:
      
      Caroline Hwang, MD
  - Murrieta, California, United States, 92563
    - Recruiting
    - United Medical Doctors
    - Contact:
      
      John Hong, MD
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Recruiting
    - Peak Gastroenterology Associates
    - Contact:
      
      Bhaktasharan Patel, MD
- Florida
  - Brandon, Florida, United States, 33511
    - Recruiting
    - Clinical Research of Brandon, LLC
    - Contact:
      
      German Alvarez, MD
  - Clearwater, Florida, United States, 33762
    - Recruiting
    - West Central Gastroenterology d/b/a Gastro Florida
    - Contact:
      
      Tejinder Glamour, MD
  - Lakeland, Florida, United States, 33813
    - Recruiting
    - Auzmer Research
    - Contact:
      
      Niaz Ausaf, MD
  - Miami, Florida, United States, 33134
    - Recruiting
    - Research Associates of South Florida, LLC
    - Contact:
      
      Alexander Veloso, MD
  - Miami Lakes, Florida, United States, 33016
    - Not yet recruiting
    - Wellness Clinical Research
    - Contact:
      
      Lucky Flores, MD
  - New Port Richey, Florida, United States, 34653
    - Recruiting
    - Advanced Research Institute, Inc.
    - Contact:
      
      Curtis Freedland, MD
  - Ocala, Florida, United States, 34474
    - Recruiting
    - Sarkis Clinical Trials - Parent
    - Contact:
      
      Vishnu Reddy, MD
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Orlando Health, Inc.
    - Contact:
      
      Udayakumar Navaneethan, MD
  - Tampa, Florida, United States, 33609
    - Recruiting
    - GCP Clinical Research, LLC
    - Contact:
      
      Alan Weintraub, MD
  - Temple Terrace, Florida, United States, 33617
    - Recruiting
    - Theia Clinical Research Centers, LLC
    - Contact:
      
      Zubair Farooqui, MD
- Illinois
  - Evanston, Illinois, United States, 60208
    - Recruiting
    - Northwestern University
    - Contact:
      
      Emanelle Bellaguarda, MD
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Not yet recruiting
    - University of Iowa Health Care
    - Contact:
      
      Steven Polyak, MD
- Massachusetts
  - New Bedford, Massachusetts, United States, 02740
    - Recruiting
    - Lucida Clinical Trials, LLC
    - Contact:
      
      Jason Reich, MD
  - Worcester, Massachusetts, United States, 01655
    - Not yet recruiting
    - University of Massachusetts, Worcester
    - Contact:
      
      Abbas Rupawala, MD
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Columbus Center
    - Contact:
      
      Najwa El-Nachef, MD
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Not yet recruiting
    - Dartmouth-Hitchcock Medical Center
    - Contact:
      
      Corey Siegel, MD
- Ohio
  - Hilliard, Ohio, United States, 43026
    - Not yet recruiting
    - OSU Inflammatory Bowel Disease Center
    - Contact:
      
      Madalina Butnariu, MD
- Pennsylvania
  - Harrisburg, Pennsylvania, United States, 17110
    - Not yet recruiting
    - Susquehanna Research Group, LLC
    - Contact:
      
      Adnan Ahmad, MD
  - Pittsburgh, Pennsylvania, United States, 15213
    - Not yet recruiting
    - UPMC
    - Contact:
      
      Marc Schwartz, MD
  - Uniontown, Pennsylvania, United States, 15401
    - Recruiting
    - Frontier Clinical Research, LLC
    - Contact:
      
      Marc Happe, MD
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Recruiting
    - Rapid City Medical Center, LLC
    - Contact:
      
      Blake Jones, MD
- Tennessee
  - Nashville, Tennessee, United States, 37212
    - Not yet recruiting
    - Vanderbilt University Medical Center
    - Contact:
      
      Audrey Bennett, MD
- Texas
  - Austin, Texas, United States, 78705
    - Not yet recruiting
    - Central Texas Clinical Research, LLC
    - Contact:
      
      Cynthia Brinson, MD
  - Baytown, Texas, United States, 77521
    - Not yet recruiting
    - Inquest Clinical Research
    - Contact:
      
      Haider Afzal, MD
  - Bellaire, Texas, United States, 77401
    - Recruiting
    - Novel Research, LLC
    - Contact:
      
      Moazzam Sana, MD
  - Cedar Park, Texas, United States, 78613
    - Recruiting
    - GI Alliance
    - Contact:
      
      Ryan Cho, MD
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Baylor University Hospital
    - Contact:
      
      Themistocles Dassopoulos, MD
  - Garland, Texas, United States, 75044
    - Not yet recruiting
    - GI Alliance - Garland
    - Contact:
      
      Harry Sarles, MD
  - Harlingen, Texas, United States, 78550
    - Recruiting
    - Texas Digestive Specialists
    - Contact:
      
      Nolan Perez, MD
  - Houston, Texas, United States, 77030
    - Not yet recruiting
    - Houston Methodist Hospital
    - Contact:
      
      Bincy Abraham, MD
  - Mansfield, Texas, United States, 76063
    - Not yet recruiting
    - Gi Alliance - Gurnee
    - Contact:
      
      Moustafa Youssef, MD
  - San Antonio, Texas, United States, 78229
    - Not yet recruiting
    - Southern Star Research Institute, LLC
    - Contact:
      
      Jeff Bullock, MD
  - Tyler, Texas, United States, 75701
    - Recruiting
    - Tyler Research Institute, LLC
    - Contact:
      
      George Aaron DuVall, MD
- Utah
  - Salt Lake City, Utah, United States, 84108
    - Recruiting
    - University of Utah
    - Contact:
      
      John Valentine, MD
- Virginia
  - Richmond, Virginia, United States, 23249
    - Not yet recruiting
    - Richmond VA Medical Center
    - Contact:
      
      William Pandak, MD
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Gastroenterology Consultants of Southwest Virginia.
    - Contact:
      
      Nirish Shah, MD
- Washington
  - Seattle, Washington, United States, 98195
    - Not yet recruiting
    - University of Washington
    - Contact:
      
      Scott Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria will be excluded from the study:

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
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.
Symptomatic bowel stricture and/or stenosis not passable in endoscopy
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
5. Any other manifestation that might require surgery while enrolled in the study
Related to CD treatments:
1. Subject who is currently treated with prohibited concomitant therapies for CD as described in the study protocol
2. Subject who has previously received natalizumab (or any other α4β1 integrin agonist)
3. 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)
History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not)
Subject with history of, or diagnosed with, the following during screening: primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis
Serious illness requiring hospitalization (not related to CD) within 4 weeks prior to screening
Subject with the following infectious conditions:
1. Chronic or recurrent Grade 3 or Grade 4 infection within the last 2 months prior to screening or history of opportunistic infection while not on immunosuppressive therapy
2. Herpes zoster reactivation within the last 2 months prior to screening
3. Active infection at screening or any major episode of infection that required hospitalization or treatment with IV antibiotics within 1 month of screening or during screening (fungal infection of nail beds is allowed)
4. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) that required treatment per local medical practice or positive test for Clostridioides difficile (C. difficile) toxin at screening.
5. Subject with human immunodeficiency virus (HIV) infection
6. Acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen [HbsAg] or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA], or detectable HBV DNA).
7. Acute or chronic hepatitis C virus (HCV) infection as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA [assessed centrally] are eligible)
8. Active tuberculosis (TB) or untreated latent TB (For subjects with positive or intermediate QuantiFERON test)
Subject with uncontrolled ischemic heart disease and/or a history of congestive heart failure
Subject with a known family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/ heart rate-corrected QT (QTc) interval
Subject with a history of torsade de pointe (TdP)
Acute or chronic clinically relevant pulmonary, hepatic, or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems.
Subjects who received live vaccine within 3 months prior to screening and/or subject who is planning to receive such a vaccine during the study duration
Acute or chronic pancreatitis
Subject with the following hematological and biochemical laboratory parameters obtained during the screening period:
1. Hemoglobin ≤ 8.0 g/dL1
2. Absolute neutrophil count < 750/mm3
3. Platelets < 100,000 /mm3
4. eGFR < 60 mL/min/1.73 m2
5. Total serum bilirubin > 1.5 x ULN (except if related to pre-existing and documented Gilbert syndrome)
6. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 x ULN
Subject who does not meet the washout period requirements prior to the screening endoscopy as described in the prohibited medication section of the study protocol
Use of any investigational or nonregistered product within 3 months or within 5 halflives preceding baseline, whichever is longer, and during the study.
Subjects previously treated with obefazimod or with a known hypersensitivity to the active substance or to any of the excipients
Illicit drug or alcohol abuse or dependence
Subject who is committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obefazimod 50mg Obefazimod 50mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)	Drug: Obefazimod Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).
Experimental: Obefazimod 25mg Obefazimod 25mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)	Drug: Obefazimod Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).
Experimental: Obefazimod 12.5mg Obefazimod 12.5mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)	Drug: Obefazimod Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).
Placebo Comparator: Placebo Placebo given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)	Other: Placebo Matching placebo will be administered QD in fed condition (ideally at the same time in the morning).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI) Time Frame: Week 12 and week 52	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) Time Frame: Week 52	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 Time Frame: Week 52	Proportion of subjects with endoscopic response at Week 52	Week 52
Maintenance Phase Efficacy - SES-CD ulcer subscore > 1 Time Frame: Week 52	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 Time Frame: Week 52	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 Time Frame: Week 52	Proportion of subjects with patient reported outcome (PRO)-2 clinical remission at Week 52	Week 52
Maintenance Phase Efficacy - CDAI clinical response Time Frame: Week 52	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 Time Frame: Week 52	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 Time Frame: Week 52	Proportion of subjects with CDAI clinical response and endoscopic response at Week 52	Week 52
Maintenance Phase Efficacy - endoscopic remission Time Frame: Week 52	Proportion of subjects with endoscopic remission at Week 52	Week 52
Extension Phase Safety- Adverse events Time Frame: Weeks 64, 76, 88,100 and EOS	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 Time Frame: Weeks 64, 76, 88,100 and EOS	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 Time Frame: Weeks 64, 76, 88,100 and EOS	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction Phase Efficacy - SES-CD Time Frame: Week 12	Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 12	Week 12
Induction Phase Efficacy - Endoscopic response Time Frame: Week 12	Proportion of subjects with endoscopic response at Week 12	Week 12
Induction Phase Efficacy-SES-CD ulcer subscore > 1 Time Frame: Week 12	Proportion of subjects with no SES-CD ulcer subscore > 1 in at least one segment at Week 12	Week 12
Induction Phase Efficacy-CDAI clinical remission Time Frame: Week 12	Proportion of subjects with Crohn's Disease Activity Index (CDAI) clinical remission (CDAI score < 150) at Week 12 The total CDAI score ranges from 0 to over 600. Higher scores mean a worse outcome	Week 12
Induction Phase Efficacy-PRO-2 clinical remission Time Frame: Week 12	Proportion of subjects with patient reported outcome (PRO)-2 clinical remission (Combination of average daily abdominal pain score ≤ 1.0 plus average daily soft or liquid stool frequency ≤ 2.8 and both no higher than baseline) at Week 12	Week 12
Induction Phase Efficacy-CDAI clinical response Time Frame: Week 12	Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) at Week 12 The total CDAI score ranges from 0 to over 600. Higher scores mean a worse outcome	Week 12
Induction Phase Efficacy-PRO-2 clinical response Time Frame: Week 12	Proportion of subjects with PRO-2 clinical response at Week 12	Week 12
Induction Phase Efficacy-CDAI clinical response and endoscopic response Time Frame: Week 12	Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) and endoscopic response (Simple Endoscopic Score for Crohn's disease (SES-CD) decrease from baseline ≥ 50%) at Week 12 The total CDAI score ranges from 0 to over 600. Higher scores mean a worse outcome The total SES-CD score ranges from 0 to 60. Higher scores mean a worse outcome.	Week 12
Induction Phase Efficacy - endoscopic remission Time Frame: Week 12	Proportion of subjects with endoscopic remission at Week 12	Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abivax S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Crohn Disease

Additional Relevant MeSH Terms

Other Study ID Numbers

ABX464-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Moderately to Severely Active Crohn Disease

Clinical Trials on Obefazimod

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