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

Status: Recruiting
Location: See all (143) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
IMC Gulf Coast Gastroenterology, PC
NOT_YET_RECRUITING
Fairhope
Arizona
Scottsdale Gastroenterology Specialists
NOT_YET_RECRUITING
Scottsdale
GI Alliance -Gurnee
RECRUITING
Sun City
California
Hoag Hospital
NOT_YET_RECRUITING
Irvine
United Medical Doctors
RECRUITING
Murrieta
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Florida
Clinical Research Of Brandon, LLC
RECRUITING
Brandon
West Central Gastroenterology d/b/a Gastro Florida
RECRUITING
Clearwater
Auzmer Research
RECRUITING
Lakeland
Research Associates of South Florida, LLC
RECRUITING
Miami
Wellness Clinical Research
NOT_YET_RECRUITING
Miami Lakes
Advanced Research Institute, Inc.
NOT_YET_RECRUITING
New Port Richey
Sarkis Clinical Trials - Parent
RECRUITING
Ocala
Orlando Health, Inc.
NOT_YET_RECRUITING
Orlando
GCP Clinical Research, LLC
RECRUITING
Tampa
Theia Clinical Research Centers, LLC
RECRUITING
Temple Terrace
Iowa
University of Iowa Health Care
NOT_YET_RECRUITING
Iowa City
Illinois
Northwestern University
NOT_YET_RECRUITING
Evanston
Massachusetts
Lucida Clinical Trials, LLC
RECRUITING
New Bedford
University of Massachusetts, Worcester
NOT_YET_RECRUITING
Worcester
Michigan
Henry Ford Columbus Center
NOT_YET_RECRUITING
Detroit
New Hampshire
Dartmouth-Hitchcock Medical Center
NOT_YET_RECRUITING
Lebanon
Ohio
OSU Inflammatory Bowel Disease Center
NOT_YET_RECRUITING
Hilliard
Pennsylvania
Susquehanna Research Group, LLC
NOT_YET_RECRUITING
Harrisburg
UPMC
NOT_YET_RECRUITING
Pittsburgh
Frontier Clinical Research, LLC
RECRUITING
Uniontown
South Dakota
Rapid City Medical Center, LLC
RECRUITING
Rapid City
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
Central Texas Clinical Research, LLC
NOT_YET_RECRUITING
Austin
Inquest Clinical Research
NOT_YET_RECRUITING
Baytown
Novel Research, LLC
RECRUITING
Bellaire
GI Alliance
RECRUITING
Cedar Park
Baylor University Hospital
RECRUITING
Dallas
GI Alliance - Garland
NOT_YET_RECRUITING
Garland
Texas Digestive Specialists
RECRUITING
Harlingen
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
GI Alliance - Gurnee
NOT_YET_RECRUITING
Mansfield
Southern Star Research Institute, LLC
NOT_YET_RECRUITING
San Antonio
Tyler Research Institute, LLC
RECRUITING
Tyler
Utah
University of Utah
RECRUITING
Salt Lake City
Virginia
Richmond VA Medical Center
NOT_YET_RECRUITING
Richmond
Gastroenterology Consultants of Southwest Virginia.
RECRUITING
Roanoke
Washington
University of Washington
NOT_YET_RECRUITING
Seattle
Other Locations
Belgium
Hopital Universitaire de Bruxelles - Hopital Erasme
RECRUITING
Brussels
AZ Maria Middelares
RECRUITING
Ghent
Universitair Ziekenhuis Gent
NOT_YET_RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
Centre Wallonie Picarde
NOT_YET_RECRUITING
Tournai
CHU UCL Namur
NOT_YET_RECRUITING
Yvoir
France
CHU Amiens
RECRUITING
Amiens
CHU Besançon - Hôpital Jean Minjoz
NOT_YET_RECRUITING
Besançon
CHU Clermont Ferrand - Hopital d'Estaing
NOT_YET_RECRUITING
Clermont-ferrand
Hôpital Henri Mondor
RECRUITING
Créteil
CHU Dijon - Hôpital Bocage Central
NOT_YET_RECRUITING
Dijon
CHU de Grenoble - Hôpital Michallon
NOT_YET_RECRUITING
Grenoble
Centre Hospitalier Départemental Vendée - Les Oudairies
NOT_YET_RECRUITING
La Roche-sur-yon
Hôpital Bicêtre
NOT_YET_RECRUITING
Le Kremlin-bicêtre
CHU Lille - Hôpital Claude Huriez
NOT_YET_RECRUITING
Lille
Hôpital Nord - CHU Marseille
NOT_YET_RECRUITING
Marseille
Hopital Saint Eloi
NOT_YET_RECRUITING
Montpellier
CHU Nantes - Hôtel Dieu
NOT_YET_RECRUITING
Nantes
Institut des MICI
NOT_YET_RECRUITING
Neuilly-sur-seine
CHU Nice - Hôpital de l'Archet 2
NOT_YET_RECRUITING
Nice
CHU Bordeaux - Hôpital Haut-Lévêque
RECRUITING
Pessac
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
CHU Saint Etienne - Hôpital Nord
NOT_YET_RECRUITING
Saint-etienne
Hopital Rangueil
NOT_YET_RECRUITING
Toulouse
Hôpital de Brabois
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Germany
Charite-Campus Benjamin Franklin Medizin.Klin.I
NOT_YET_RECRUITING
Berlin
Krankenhaus Waldfriede e. V.
NOT_YET_RECRUITING
Berlin
Universitaetsklinikum Brandenburg an der Havel
NOT_YET_RECRUITING
Brandenburg
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
Universitaetsklinikum Frankfurt Goethe-Universitaet
NOT_YET_RECRUITING
Frankfurt Am Main
Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen
NOT_YET_RECRUITING
Hamburg
Medizinische Hochschule Hannover
NOT_YET_RECRUITING
Hanover
Universitaetsklinikum Heidelberg
NOT_YET_RECRUITING
Heidelberg
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
NOT_YET_RECRUITING
Kiel
St. Marienkrankenhaus
NOT_YET_RECRUITING
Ludwigshafen
LMU - Campus Grosshadern
NOT_YET_RECRUITING
München
Universitaetsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Hungary
Bekes Varmegyei Kozponti Korhaz
RECRUITING
Békéscsaba
Obudai Egeszsegugyi Centrum Kft.
NOT_YET_RECRUITING
Budapest
Pannonia Maganorvosi Centrum
RECRUITING
Budapest
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Gyongyosi Bugat Pal Korhaz
NOT_YET_RECRUITING
Gyöngyös
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
NOT_YET_RECRUITING
Székesfehérvár
Clinfan Szolgaltato Kft.
NOT_YET_RECRUITING
Szekszárd
Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
NOT_YET_RECRUITING
Bologna
Azienda Ospedaliera Universitaria Renato Dulbecco di Catanzaro
NOT_YET_RECRUITING
Catanzaro
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Ospedale Sacro Cuore Don Calabria
NOT_YET_RECRUITING
Negrar
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Università Campus Bio-Medico di Roma
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
IRCCS Ospedale Casa Sollievo della Sofferenza
NOT_YET_RECRUITING
San Giovanni Rotondo
Netherlands
Amsterdam UMC, Locatie AMC
RECRUITING
Amsterdam
Maastricht University Medical Center
NOT_YET_RECRUITING
Maastricht
Radboud UMC
NOT_YET_RECRUITING
Nijmegen
ETZ Elisabeth
RECRUITING
Tilburg
Bernhoven Uden
NOT_YET_RECRUITING
Uden
Poland
Centrum Medyczne Medis
NOT_YET_RECRUITING
Bydgoszcz
NZOZ Centrum Medyczne KERmed
NOT_YET_RECRUITING
Bydgoszcz
Santa Sp. z o.o. Sp. K Polimedica PTG Kielce
NOT_YET_RECRUITING
Kielce
Mz Badania Slowik Zymla Sp J
RECRUITING
Knurów
Centrum Medyczne Plejady
RECRUITING
Krakow
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej
RECRUITING
Łęczna
AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa
NOT_YET_RECRUITING
Lodz
ALLMEDICA sp. z o. o.
NOT_YET_RECRUITING
Nowy Targ
Twoja Przychodnia Opolskie Centrum Medyczne
RECRUITING
Opole
Trialmed CRS
NOT_YET_RECRUITING
Piotrkow Trybunalski
Twoja Przychodnia PCM
RECRUITING
Późna
NSZOZ Termedica - Centrum Badan Klinicznych
NOT_YET_RECRUITING
Poznan
SOLUMED Centrum Medyczne
NOT_YET_RECRUITING
Poznan
Gabinet Lekarski Bartosz Korczowski
NOT_YET_RECRUITING
Rzeszów
Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
RECRUITING
Sosnowiec
DC-MED
RECRUITING
Swidnica
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
RECRUITING
Szczecin
Centrum Zdrowia MDM
RECRUITING
Warsaw
Medical Network Spolka z o.o
RECRUITING
Warsaw
NZOZ VIVAMED Jadwiga Miecz
RECRUITING
Warsaw
Melita Medical Sp. Z O. O.
RECRUITING
Wroclaw
ETG Zamosc
NOT_YET_RECRUITING
Zamość
Romania
S.C Delta Health Care S.R.L
RECRUITING
Bucharest
SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
RECRUITING
Bucharest
Spitalul Clinic Colentina
NOT_YET_RECRUITING
Bucharest
S.C Pelican Impex S.R.L
NOT_YET_RECRUITING
Oradea
Valahia Medical SRL
RECRUITING
Ploieşti
Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
RECRUITING
Banská Bystrica
Cliniq s.r.o.
RECRUITING
Bratislava
Endomed, s.r.o.
RECRUITING
Košice
KM Management spol. s r.o.
NOT_YET_RECRUITING
Nitra
Gastro I, s.r.o.
RECRUITING
Prešov
Penta hospitals SK, a.s.
RECRUITING
Rimavská Sobota
Spain
Centro Medico Teknon
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Reina Sofia
NOT_YET_RECRUITING
Córdoba
Hospital Universitario de Fuenlabrada
NOT_YET_RECRUITING
Fuenlabrada
Hospital General Juan Ramon Jimenez
RECRUITING
Huelva
Hospital Universitario de Gran Canaria Dr. Negrin
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Clinica Gaias - Santiago
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocio
NOT_YET_RECRUITING
Seville
Hospital Clinico Universitario de Valencia
NOT_YET_RECRUITING
Valencia
Contact Information
Primary
Study Director
info@abivax.com
+33 (0) 1 53 83 09 63
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2028-04
Participants
Target number of participants: 212
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Abivax S.A.

This content was sourced from clinicaltrials.gov