Actively Recruiting
Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
Led by Abivax S.A. · Updated on 2026-04-27
212
Participants Needed
149
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female (at birth) aged 18 to 75 years able to understand and sign informed consent
- Able and willing to comply with study visits and procedures
- Confirmed diagnosis of Crohn's Disease based on endoscopy and histology
- Moderately to severely active Crohn's Disease defined by CDAI between 220 and 450 and SES-CD scores (≥6 for ileo-colonic or colonic, ≥4 for isolated ileal disease)
- Documented inadequate response, loss of response, or intolerance to at least one treatment: corticosteroids, immunosuppressants, biologics or biosimilars, or janus kinase inhibitors
- Women of childbearing potential and male partners must agree to contraception requirements
- Affiliated with a health insurance policy if required
- Able and willing to follow usual public sun protection recommendations
You will not qualify if you...
- Pregnant or breastfeeding women or males with partners planning pregnancy during the study
- Current diagnosis of ulcerative colitis or indeterminate colitis
- Crohn's Disease without ileal or colonic involvement
- Untreated active external or perianal fistula or abscess; stable fistula with minimal drainage allowed
- Symptomatic bowel stricture or stenosis not passable by endoscopy
- Current stoma, ileoanal pouch, or significant bowel resections as specified
- Recent bowel surgery within 3 months prior to baseline
- Receiving prohibited concomitant therapies or prior treatment with natalizumab or similar
- Failure of more than three advanced therapies or two different mechanisms of action
- History or active malignancy except disease-free for 5 years
- History of colonic cancer, dysplasia, or adenomatous polyps
- Diagnosis of primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis
- Serious illness requiring hospitalization within 4 weeks prior to screening
- Recent severe infections or positive tests for certain infections including HIV, hepatitis B or C, or tuberculosis
- Uncontrolled ischemic heart disease or congestive heart failure
- Known long QT syndrome or prolonged QT interval
- History of torsade de pointe
- Significant pulmonary, hepatic, renal, neurological, or other medical abnormalities
- Live vaccine within 3 months prior to screening or planned during study
- Acute or chronic pancreatitis
- Hematological or biochemical abnormalities as specified
- Failure to meet washout periods before screening
- Use of investigational or nonregistered products within 3 months or 5 half-lives prior to baseline
- Prior treatment with obefazimod or known hypersensitivity
- Illicit drug or alcohol abuse
- Institutionalization by judicial or administrative order
- Any condition compromising safety or study adherence as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 149 locations
1
IMC Gulf Coast Gastroenterology, PC
Fairhope, Alabama, United States, 36532
Not Yet Recruiting
2
Scottsdale Gastroenterology Specialists
Scottsdale, Arizona, United States, 85260
Not Yet Recruiting
3
GI Alliance -Gurnee
Sun City, Arizona, United States, 85351
Actively Recruiting
4
Hoag Hospital
Irvine, California, United States, 92618
Not Yet Recruiting
5
United Medical Doctors
Murrieta, California, United States, 92563
Actively Recruiting
6
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
7
Clinical Research Of Brandon, LLC
Brandon, Florida, United States, 33511
Actively Recruiting
8
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, United States, 33762
Actively Recruiting
9
Auzmer Research
Lakeland, Florida, United States, 33813
Actively Recruiting
10
Research Associates of South Florida, LLC
Miami, Florida, United States, 33134
Actively Recruiting
11
Wellness Clinical Research
Miami Lakes, Florida, United States, 33016
Not Yet Recruiting
12
Advanced Research Institute, Inc.
New Port Richey, Florida, United States, 34653
Actively Recruiting
13
Sarkis Clinical Trials - Parent
Ocala, Florida, United States, 34474
Actively Recruiting
14
Orlando Health, Inc.
Orlando, Florida, United States, 32806
Actively Recruiting
15
GCP Clinical Research, LLC
Tampa, Florida, United States, 33609
Actively Recruiting
16
Theia Clinical Research Centers, LLC
Temple Terrace, Florida, United States, 33617
Actively Recruiting
17
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
18
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
19
Lucida Clinical Trials, LLC
New Bedford, Massachusetts, United States, 02740
Actively Recruiting
20
University of Massachusetts, Worcester
Worcester, Massachusetts, United States, 01655
Not Yet Recruiting
21
Henry Ford Columbus Center
Detroit, Michigan, United States, 48202
Actively Recruiting
22
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Not Yet Recruiting
23
OSU Inflammatory Bowel Disease Center
Hilliard, Ohio, United States, 43026
Not Yet Recruiting
24
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, United States, 17110
Not Yet Recruiting
25
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
26
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, United States, 15401
Actively Recruiting
27
Rapid City Medical Center, LLC
Rapid City, South Dakota, United States, 57701
Actively Recruiting
28
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Not Yet Recruiting
29
Central Texas Clinical Research, LLC
Austin, Texas, United States, 78705
Not Yet Recruiting
30
Inquest Clinical Research
Baytown, Texas, United States, 77521
Not Yet Recruiting
31
Novel Research, LLC
Bellaire, Texas, United States, 77401
Actively Recruiting
32
GI Alliance
Cedar Park, Texas, United States, 78613
Actively Recruiting
33
Baylor University Hospital
Dallas, Texas, United States, 75246
Actively Recruiting
34
GI Alliance - Garland
Garland, Texas, United States, 75044
Not Yet Recruiting
35
Texas Digestive Specialists
Harlingen, Texas, United States, 78550
Actively Recruiting
36
Houston Methodist Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
37
GI Alliance - Gurnee
Mansfield, Texas, United States, 76063
Not Yet Recruiting
38
Southern Star Research Institute, LLC
San Antonio, Texas, United States, 78229
Not Yet Recruiting
39
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
Actively Recruiting
40
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
41
Richmond VA Medical Center
Richmond, Virginia, United States, 23249
Not Yet Recruiting
42
Gastroenterology Consultants of Southwest Virginia.
Roanoke, Virginia, United States, 24014
Actively Recruiting
43
University of Washington
Seattle, Washington, United States, 98195
Not Yet Recruiting
44
Hopital Universitaire de Bruxelles - Hopital Erasme
Brussels, Belgium
Actively Recruiting
45
AZ Maria Middelares
Ghent, Belgium
Actively Recruiting
46
Universitair Ziekenhuis Gent
Ghent, Belgium
Not Yet Recruiting
47
UZ Leuven
Leuven, Belgium
Actively Recruiting
48
Centre Wallonie Picarde
Tournai, Belgium
Not Yet Recruiting
49
CHU UCL Namur
Yvoir, Belgium
Actively Recruiting
50
SurGal Clinic s.r.o.
Brno, Czechia
Actively Recruiting
51
Vojenska nemocnice Brno
Brno, Czechia
Actively Recruiting
52
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, Czechia
Not Yet Recruiting
53
PreventaMed s.r.o.
Olomouc, Czechia
Actively Recruiting
54
ISCARE a.s.
Prague, Czechia
Not Yet Recruiting
55
Nemocnice Slany
Slaný, Czechia
Actively Recruiting
56
CHU Amiens
Amiens, France
Actively Recruiting
57
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
Not Yet Recruiting
58
CHU Clermont Ferrand - Hopital d'Estaing
Clermont-Ferrand, France
Actively Recruiting
59
Hôpital Henri Mondor
Créteil, France
Actively Recruiting
60
CHU Dijon - Hôpital Bocage Central
Dijon, France
Not Yet Recruiting
61
CHU de Grenoble - Hôpital Michallon
Grenoble, France
Not Yet Recruiting
62
Centre Hospitalier Départemental Vendée - Les Oudairies
La Roche-sur-Yon, France
Not Yet Recruiting
63
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Not Yet Recruiting
64
CHU Lille - Hôpital Claude Huriez
Lille, France
Not Yet Recruiting
65
Hôpital Nord - CHU Marseille
Marseille, France
Not Yet Recruiting
66
Hopital Saint Eloi
Montpellier, France
Actively Recruiting
67
CHU Nantes - Hôtel Dieu
Nantes, France
Not Yet Recruiting
68
Institut des MICI
Neuilly-sur-Seine, France
Actively Recruiting
69
CHU Nice - Hôpital de l'Archet 2
Nice, France
Not Yet Recruiting
70
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, France
Actively Recruiting
71
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Actively Recruiting
72
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, France
Not Yet Recruiting
73
Hopital Rangueil
Toulouse, France
Actively Recruiting
74
Hôpital de Brabois
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
75
Charite-Campus Benjamin Franklin Medizin.Klin.I
Berlin, Germany
Not Yet Recruiting
76
Krankenhaus Waldfriede e. V.
Berlin, Germany
Actively Recruiting
77
Universitaetsklinikum Brandenburg an der Havel
Brandenburg an der Havel, Germany
Not Yet Recruiting
78
Universitaetsklinikum Erlangen
Erlangen, Germany
Actively Recruiting
79
Universitaetsklinikum Frankfurt Goethe-Universitaet
Frankfurt am Main, Germany
Not Yet Recruiting
80
Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen
Hamburg, Germany
Actively Recruiting
81
Medizinische Hochschule Hannover
Hanover, Germany
Actively Recruiting
82
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Not Yet Recruiting
83
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany
Actively Recruiting
84
St. Marienkrankenhaus
Ludwigshafen, Germany
Actively Recruiting
85
LMU - Campus Grosshadern
München, Germany
Not Yet Recruiting
86
Universitaetsklinikum Ulm
Ulm, Germany
Actively Recruiting
87
Bekes Varmegyei Kozponti Korhaz
Békéscsaba, Hungary
Actively Recruiting
88
Obudai Egeszsegugyi Centrum Kft.
Budapest, Hungary
Not Yet Recruiting
89
Pannonia Maganorvosi Centrum
Budapest, Hungary
Actively Recruiting
90
Semmelweis Egyetem
Budapest, Hungary
Actively Recruiting
91
Semmelweis Egyetem
Budapest, Hungary
Not Yet Recruiting
92
Gyongyosi Bugat Pal Korhaz
Gyöngyös, Hungary
Not Yet Recruiting
93
Clinfan Szolgaltato Kft.
Szekszárd, Hungary
Not Yet Recruiting
94
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary
Actively Recruiting
95
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Italy
Not Yet Recruiting
96
Azienda Ospedaliera Universitaria Renato Dulbecco di Catanzaro
Catanzaro, Italy
Not Yet Recruiting
97
Ospedale San Raffaele
Milan, Italy
Actively Recruiting
98
Ospedale Sacro Cuore Don Calabria
Negrar, Italy
Not Yet Recruiting
99
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Actively Recruiting
100
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Actively Recruiting
101
Università Campus Bio-Medico di Roma
Roma, Italy
Actively Recruiting
102
Istituto Clinico Humanitas
Rozzano, Italy
Actively Recruiting
103
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Actively Recruiting
104
Amsterdam UMC, Locatie AMC
Amsterdam, Netherlands
Actively Recruiting
105
Maastricht University Medical Center
Maastricht, Netherlands
Not Yet Recruiting
106
Radboud UMC
Nijmegen, Netherlands
Not Yet Recruiting
107
ETZ Elisabeth
Tilburg, Netherlands
Actively Recruiting
108
Bernhoven Uden
Uden, Netherlands
Not Yet Recruiting
109
Centrum Medyczne Medis
Bydgoszcz, Poland
Actively Recruiting
110
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Poland
Not Yet Recruiting
111
Santa Sp. z o.o. Sp. K Polimedica PTG Kielce
Kielce, Poland
Not Yet Recruiting
112
Mz Badania Slowik Zymla Sp J
Knurów, Poland
Actively Recruiting
113
Centrum Medyczne Plejady
Krakow, Poland
Actively Recruiting
114
AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa
Lodz, Poland
Actively Recruiting
115
ALLMEDICA sp. z o. o.
Nowy Targ, Poland
Actively Recruiting
116
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, Poland
Actively Recruiting
117
Trialmed CRS
Piotrkow Trybunalski, Poland
Not Yet Recruiting
118
NSZOZ Termedica - Centrum Badan Klinicznych
Poznan, Poland
Not Yet Recruiting
119
SOLUMED Centrum Medyczne
Poznan, Poland
Actively Recruiting
120
Twoja Przychodnia PCM
Późna, Poland
Actively Recruiting
121
Gabinet Lekarski Bartosz Korczowski
Rzeszów, Poland
Not Yet Recruiting
122
Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
Sosnowiec, Poland
Actively Recruiting
123
DC-MED
Swidnica, Poland
Actively Recruiting
124
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
Szczecin, Poland
Actively Recruiting
125
Centrum Zdrowia MDM
Warsaw, Poland
Actively Recruiting
126
Medical Network Spolka z o.o
Warsaw, Poland
Actively Recruiting
127
NZOZ VIVAMED Jadwiga Miecz
Warsaw, Poland
Actively Recruiting
128
Melita Medical Sp. Z O. O.
Wroclaw, Poland
Actively Recruiting
129
ETG Zamosc
Zamość, Poland
Not Yet Recruiting
130
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej
Łęczna, Poland
Actively Recruiting
131
S.C Delta Health Care S.R.L
Bucharest, Romania
Actively Recruiting
132
SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
Bucharest, Romania
Actively Recruiting
133
Spitalul Clinic Colentina
Bucharest, Romania
Not Yet Recruiting
134
S.C Pelican Impex S.R.L
Oradea, Romania
Not Yet Recruiting
135
Valahia Medical SRL
Ploieşti, Romania
Actively Recruiting
136
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, Slovakia
Actively Recruiting
137
Cliniq s.r.o.
Bratislava, Slovakia
Actively Recruiting
138
Endomed, s.r.o.
Košice, Slovakia
Actively Recruiting
139
KM Management spol. s r.o.
Nitra, Slovakia
Actively Recruiting
140
Gastro I, s.r.o.
Prešov, Slovakia
Actively Recruiting
141
Penta hospitals SK, a.s.
Rimavská Sobota, Slovakia
Actively Recruiting
142
Centro Medico Teknon
Barcelona, Spain
Actively Recruiting
143
Hospital Universitario Reina Sofia
Córdoba, Spain
Not Yet Recruiting
144
Hospital Universitario de Fuenlabrada
Fuenlabrada, Spain
Not Yet Recruiting
145
Hospital General Juan Ramon Jimenez
Huelva, Spain
Actively Recruiting
146
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain
Actively Recruiting
147
Clinica Gaias - Santiago
Santiago de Compostela, Spain
Actively Recruiting
148
Hospital Universitario Virgen del Rocio
Seville, Spain
Not Yet Recruiting
149
Hospital Clinico Universitario de Valencia
Valencia, Spain
Not Yet Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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