Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06456593

PHASE2

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

212

Start Date

2024-10-30

Completion Date

2028-04

Last Updated

2025-09-18

Healthy Volunteers

Conditions

Moderately to Severely Active Crohn Disease

Interventions

DRUG

Obefazimod

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

OTHER

Placebo

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

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: Subjects who meet any of the following exclusion criteria will be excluded from the study: 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 5. Any other manifestation that might require surgery while enrolled in the study 7. 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 8. History of, or active, malignancy including nonmelanoma skin cancer (subjects with a 5-year disease-free survival are eligible) 9. 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) 10. Subject with history of, or diagnosed with, the following during screening: primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis 11. Serious illness requiring hospitalization (not related to CD) within 4 weeks prior to screening 12. 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) 13. Subject with uncontrolled ischemic heart disease and/or a history of congestive heart failure 14. 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 15. Subject with a history of torsade de pointe (TdP) 16. 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. 17. 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 18. Acute or chronic pancreatitis 19. 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 20. 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 21. Use of any investigational or nonregistered product within 3 months or within 5 halflives preceding baseline, whichever is longer, and during the study. 22. Subjects previously treated with obefazimod or with a known hypersensitivity to the active substance or to any of the excipients 23. Illicit drug or alcohol abuse or dependence 24. Subject who is committed to an institution by virtue of an order issued either by the judicial or the administrative authorities 25. Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol

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

Wellness Clinical Research

Miami Lakes, Florida, United States

Advanced Research Institute, Inc.

New Port Richey, Florida, United States

Sarkis Clinical Trials - Parent

Ocala, Florida, United States

Orlando Health, Inc.

Orlando, Florida, United States

GCP Clinical Research, LLC

Tampa, Florida, United States

Theia Clinical Research Centers, LLC

Temple Terrace, Florida, United States

Northwestern University

Evanston, Illinois, United States

University of Iowa Health Care

Iowa City, Iowa, United States

Lucida Clinical Trials, LLC

New Bedford, Massachusetts, United States

University of Massachusetts, Worcester

Worcester, Massachusetts, United States

Henry Ford Columbus Center

Detroit, Michigan, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

OSU Inflammatory Bowel Disease Center

Hilliard, Ohio, United States

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, United States

Rapid City Medical Center, LLC

Rapid City, South Dakota, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Central Texas Clinical Research, LLC

Austin, Texas, United States

Inquest Clinical Research

Baytown, Texas, United States

Novel Research, LLC

Bellaire, Texas, United States

GI Alliance

Cedar Park, Texas, United States

Baylor University Hospital

Dallas, Texas, United States

GI Alliance - Garland

Garland, Texas, United States

Texas Digestive Specialists

Harlingen, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

GI Alliance - Gurnee

Mansfield, Texas, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Richmond VA Medical Center

Richmond, Virginia, United States

Gastroenterology Consultants of Southwest Virginia.

Roanoke, Virginia, United States

University of Washington

Seattle, Washington, United States

Hopital Universitaire de Bruxelles - Hopital Erasme

Brussels, Belgium

AZ Maria Middelares

Ghent, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Centre Wallonie Picarde

Tournai, Belgium

CHU UCL Namur

Yvoir, Belgium

SurGal Clinic s.r.o.

Brno, Czechia

Vojenska nemocnice Brno

Brno, Czechia

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, Czechia

PreventaMed s.r.o.

Olomouc, Czechia

ISCARE a.s.

Prague, Czechia

Nemocnice Slany

Slaný, Czechia

CHU Amiens

Amiens, France

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

CHU Clermont Ferrand - Hopital d'Estaing

Clermont-Ferrand, France

Hôpital Henri Mondor

Créteil, France

CHU Dijon - Hôpital Bocage Central

Dijon, France

CHU de Grenoble - Hôpital Michallon

Grenoble, France

Centre Hospitalier Départemental Vendée - Les Oudairies

La Roche-sur-Yon, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

CHU Lille - Hôpital Claude Huriez

Lille, France

Hôpital Nord - CHU Marseille

Marseille, France

Hopital Saint Eloi

Montpellier, France

CHU Nantes - Hôtel Dieu

Nantes, France

Institut des MICI

Neuilly-sur-Seine, France

CHU Nice - Hôpital de l'Archet 2

Nice, France

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, France

Hopital Rangueil

Toulouse, France

Hôpital de Brabois

Vandœuvre-lès-Nancy, France

Charite-Campus Benjamin Franklin Medizin.Klin.I

Berlin, Germany

Krankenhaus Waldfriede e. V.

Berlin, Germany

Universitaetsklinikum Brandenburg an der Havel

Brandenburg, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Universitaetsklinikum Frankfurt Goethe-Universitaet

Frankfurt am Main, Germany

Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Germany

St. Marienkrankenhaus

Ludwigshafen, Germany

LMU - Campus Grosshadern

München, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Bekes Varmegyei Kozponti Korhaz

Békéscsaba, Hungary

Obudai Egeszsegugyi Centrum Kft.

Budapest, Hungary

Pannonia Maganorvosi Centrum

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Gyongyosi Bugat Pal Korhaz

Gyöngyös, Hungary

Clinfan Szolgaltato Kft.

Szekszárd, Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, Hungary

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Italy

Azienda Ospedaliera Universitaria Renato Dulbecco di Catanzaro

Catanzaro, Italy

Ospedale San Raffaele

Milan, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Università Campus Bio-Medico di Roma

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Amsterdam UMC, Locatie AMC

Amsterdam, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Radboud UMC

Nijmegen, Netherlands

ETZ Elisabeth

Tilburg, Netherlands

Bernhoven Uden

Uden, Netherlands

Centrum Medyczne Medis

Bydgoszcz, Poland

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Poland

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

Kielce, Poland

Mz Badania Slowik Zymla Sp J

Knurów, Poland

Centrum Medyczne Plejady

Krakow, Poland

AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa

Lodz, Poland

ALLMEDICA sp. z o. o.

Nowy Targ, Poland

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, Poland

Trialmed CRS

Piotrkow Trybunalski, Poland

NSZOZ Termedica - Centrum Badan Klinicznych

Poznan, Poland

SOLUMED Centrum Medyczne

Poznan, Poland

Twoja Przychodnia PCM

Późna, Poland

Gabinet Lekarski Bartosz Korczowski

Rzeszów, Poland

Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

Sosnowiec, Poland

DC-MED

Swidnica, Poland

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

Szczecin, Poland

Centrum Zdrowia MDM

Warsaw, Poland

Medical Network Spolka z o.o

Warsaw, Poland

NZOZ VIVAMED Jadwiga Miecz

Warsaw, Poland

Melita Medical Sp. Z O. O.

Wroclaw, Poland

ETG Zamosc

Zamość, Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

Łęczna, Poland

S.C Delta Health Care S.R.L

Bucharest, Romania

SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie

Bucharest, Romania

Spitalul Clinic Colentina

Bucharest, Romania

S.C Pelican Impex S.R.L

Oradea, Romania

Valahia Medical SRL

Ploieşti, Romania

Fakultna nemocnica s poliklinikou F.D. Roosevelta

Banská Bystrica, Slovakia

Cliniq s.r.o.

Bratislava, Slovakia

Endomed, s.r.o.

Košice, Slovakia

KM Management spol. s r.o.

Nitra, Slovakia

Gastro I, s.r.o.

Prešov, Slovakia

Penta hospitals SK, a.s.

Rimavská Sobota, Slovakia

Centro Medico Teknon

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Spain

Hospital General Juan Ramon Jimenez

Huelva, Spain

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, Spain

Clinica Gaias - Santiago

Santiago de Compostela, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (149)