AzTrials
AzTrials

Moderately to Severely Active Crohn DiseasePhase 2ENHANCE-CDNCT06456593

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

A Phase 2 study testing Obefazimod in people with Moderately to Severely Active Crohn Disease, run by Abivax S.A. at 149 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Obefazimod
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
212 participants
Where
149 sitesin 12 countries
Study dates
30 Oct 2024to Apr 2028
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 48Show fewer
  • 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)
  • 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:
  • 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
  • Herpes zoster reactivation within the last 2 months prior to screening
  • 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)
  • 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.
  • Subject with human immunodeficiency virus (HIV) infection
  • 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).
  • 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)
  • 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:
  • Hemoglobin ≤ 8.0 g/dL1
  • Absolute neutrophil count < 750/mm3
  • Platelets < 100,000 /mm3
  • eGFR < 60 mL/min/1.73 m2
  • Total serum bilirubin > 1.5 x ULN (except if related to pre-existing and documented Gilbert syndrome)
  • 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

Trial locations and contacts

149 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

+33 (0) 1 53 83 09 63

info@abivax.com

149 sites in 12 countries

United States43 sites, 43 recruiting

  • Central Texas Clinical Research, LLC

    Austin, Texas, 78705

    Cynthia Brinson, MD

    Not yet recruiting

  • Inquest Clinical Research

    Baytown, Texas, 77521

    Haider Afzal, MD

    Not yet recruiting

  • Novel Research, LLC

    Bellaire, Texas, 77401

    Moazzam Sana, MD

    Recruiting

  • Clinical Research Of Brandon, LLC

    Brandon, Florida, 33511

    German Alvarez, MD

    Recruiting

  • GI Alliance

    Cedar Park, Texas, 78613

    Ryan Cho, MD

    Recruiting

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33762

    Tejinder Glamour, MD

    Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

    Bhaktasharan Patel, MD

    Recruiting

  • Baylor University Hospital

    Dallas, Texas, 75246

    Themistocles Dassopoulos, MD

    Recruiting

  • Henry Ford Columbus Center

    Detroit, Michigan, 48202

    Najwa El-Nachef, MD

    Recruiting

  • Northwestern University

    Evanston, Illinois, 60208

    Emanelle Bellaguarda, MD

    Recruiting

  • IMC Gulf Coast Gastroenterology, PC

    Fairhope, Alabama, 36532

    Nathaniel Winstead, MD

    Not yet recruiting

  • GI Alliance - Garland

    Garland, Texas, 75044

    Harry Sarles, MD

    Not yet recruiting

  • Texas Digestive Specialists

    Harlingen, Texas, 78550

    Nolan Perez, MD

    Recruiting

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110

    Adnan Ahmad, MD

    Not yet recruiting

  • OSU Inflammatory Bowel Disease Center

    Hilliard, Ohio, 43026

    Madalina Butnariu, MD

    Not yet recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Bincy Abraham, MD

    Not yet recruiting

  • University of Iowa Health Care

    Iowa City, Iowa, 52242

    Steven Polyak, MD

    Not yet recruiting

  • Hoag Hospital

    Irvine, California, 92618

    Caroline Hwang, MD

    Not yet recruiting

  • Auzmer Research

    Lakeland, Florida, 33813

    Niaz Ausaf, MD

    Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Corey Siegel, MD

    Not yet recruiting

  • GI Alliance - Gurnee

    Mansfield, Texas, 76063

    Moustafa Youssef, MD

    Not yet recruiting

  • Research Associates of South Florida, LLC

    Miami, Florida, 33134

    Alexander Veloso, MD

    Recruiting

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

    Lucky Flores, MD

    Not yet recruiting

  • United Medical Doctors

    Murrieta, California, 92563

    John Hong, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

    Audrey Bennett, MD

    Not yet recruiting

  • Lucida Clinical Trials, LLC

    New Bedford, Massachusetts, 02740

    Jason Reich, MD

    Recruiting

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

    Curtis Freedland, MD

    Recruiting

  • Sarkis Clinical Trials - Parent

    Ocala, Florida, 34474

    Vishnu Reddy, MD

    Recruiting

  • Orlando Health, Inc.

    Orlando, Florida, 32806

    Udayakumar Navaneethan, MD

    Recruiting

  • UPMC

    Pittsburgh, Pennsylvania, 15213

    Marc Schwartz, MD

    Not yet recruiting

  • Rapid City Medical Center, LLC

    Rapid City, South Dakota, 57701

    Blake Jones, MD

    Recruiting

  • Richmond VA Medical Center

    Richmond, Virginia, 23249

    William Pandak, MD

    Not yet recruiting

  • Gastroenterology Consultants of Southwest Virginia.

    Roanoke, Virginia, 24014

    Nirish Shah, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84108

    John Valentine, MD

    Recruiting

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

    Jeff Bullock, MD

    Not yet recruiting

  • Scottsdale Gastroenterology Specialists

    Scottsdale, Arizona, 85260

    S. Jaffrey Kazi, MD

    Not yet recruiting

  • University of Washington

    Seattle, Washington, 98195

    Scott Lee, MD

    Not yet recruiting

  • GI Alliance -Gurnee

    Sun City, Arizona, 85351

    Chirag Trivedi, MD

    Recruiting

  • GCP Clinical Research, LLC

    Tampa, Florida, 33609

    Alan Weintraub, MD

    Recruiting

  • Theia Clinical Research Centers, LLC

    Temple Terrace, Florida, 33617

    Zubair Farooqui, MD

    Recruiting

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

    George Aaron DuVall, MD

    Recruiting

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania, 15401

    Marc Happe, MD

    Recruiting

  • University of Massachusetts, Worcester

    Worcester, Massachusetts, 01655

    Abbas Rupawala, MD

    Not yet recruiting

Other trials in United States

Poland22 sites, 22 recruiting

  • Centrum Medyczne Medis

    Bydgoszcz

    Maria Klopocka, MD

    Recruiting

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz

    Patryk Korga, MD

    Not yet recruiting

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

    Kielce

    Dariusz Solowiej, MD

    Not yet recruiting

  • Mz Badania Slowik Zymla Sp J

    Knurów

    Maciej Zymla, MD

    Recruiting

  • Centrum Medyczne Plejady

    Krakow

    Monika Augustyn, MD

    Recruiting

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

    Łęczna

    Lukasz Wolanski, MD

    Recruiting

  • AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa

    Lodz

    Rafal Drozda, MD

    Recruiting

  • ALLMEDICA sp. z o. o.

    Nowy Targ

    Mikolaj Krzyzanowski, MD

    Recruiting

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole

    Marzena Kwinto, MD

    Recruiting

  • Trialmed CRS

    Piotrkow Trybunalski

    Beata Neneman, MD

    Not yet recruiting

  • Twoja Przychodnia PCM

    Późna

    Ewa Furmanowska-Ladorska, MD

    Recruiting

  • NSZOZ Termedica - Centrum Badan Klinicznych

    Poznan

    Jacek Paszkowski, MD

    Not yet recruiting

  • SOLUMED Centrum Medyczne

    Poznan

    Magdalena Andrzejewska, MD

    Recruiting

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów

    Bartosz Korczowski, MD

    Not yet recruiting

  • Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

    Sosnowiec

    Lukasz Firkowski, MD

    Recruiting

  • DC-MED

    Swidnica

    Witold Marczynski, MD

    Recruiting

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

    Szczecin

    Beata Gawdis Wojnarska, MD

    Recruiting

  • Centrum Zdrowia MDM

    Warsaw

    Marek Woynarowski, MD

    Recruiting

  • Medical Network Spolka z o.o

    Warsaw

    Jaroslaw Kierkus, MD

    Recruiting

  • NZOZ VIVAMED Jadwiga Miecz

    Warsaw

    Robert Petryka, MD

    Recruiting

  • Melita Medical Sp. Z O. O.

    Wroclaw

    Jaroslaw Leszczyszyn, MD

    Recruiting

  • ETG Zamosc

    Zamość

    Katarzyna Wojcik, MD

    Not yet recruiting

Other trials in Poland

France19 sites, 19 recruiting

  • CHU Amiens

    Amiens

    Mathurin Fumery, MD

    Recruiting

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon

    Lucine Vuitton, MD

    Not yet recruiting

  • CHU Clermont Ferrand - Hopital d'Estaing

    Clermont-Ferrand

    Anthony Buisson, MD

    Recruiting

  • Hôpital Henri Mondor

    Créteil

    Mathieu Uzzan, MD

    Recruiting

  • CHU Dijon - Hôpital Bocage Central

    Dijon

    Maeva Charkaoui, MD

    Not yet recruiting

  • CHU de Grenoble - Hôpital Michallon

    Grenoble

    Marianne Hupe, MD

    Not yet recruiting

  • Centre Hospitalier Départemental Vendée - Les Oudairies

    La Roche-sur-Yon

    Morgane Amil, MD

    Not yet recruiting

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

    Aurelien Amiot, MD

    Not yet recruiting

  • CHU Lille - Hôpital Claude Huriez

    Lille

    Maria Nachury, MD

    Not yet recruiting

  • Hôpital Nord - CHU Marseille

    Marseille

    Melanie Serrero, MD

    Not yet recruiting

  • Hopital Saint Eloi

    Montpellier

    Romain Altwegg, MD

    Recruiting

  • CHU Nantes - Hôtel Dieu

    Nantes

    Catherine Le Berre, MD

    Not yet recruiting

  • Institut des MICI

    Neuilly-sur-Seine

    Xavier Treton, MD

    Recruiting

  • CHU Nice - Hôpital de l'Archet 2

    Nice

    Adrien Nicolau, MD

    Not yet recruiting

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac

    David Laharie, MD

    Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

    Stephane Nancey, MD

    Recruiting

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne

    Xavier Roblin, MD

    Not yet recruiting

  • Hopital Rangueil

    Toulouse

    Cyrielle Gilletta de Saint Joseph, MD

    Recruiting

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy

    Benedicte Caron, MD

    Not yet recruiting

Other trials in France

Germany12 sites, 12 recruiting

  • Charite-Campus Benjamin Franklin Medizin.Klin.I

    Berlin

    Britta Siegmund, MD

    Not yet recruiting

  • Krankenhaus Waldfriede e. V.

    Berlin

    Carsten Buening, MD

    Recruiting

  • Universitaetsklinikum Brandenburg an der Havel

    Brandenburg an der Havel

    Stefan Lueth, MD

    Not yet recruiting

  • Universitaetsklinikum Erlangen

    Erlangen

    Raja Atreya, MD

    Recruiting

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt am Main

    Irina Blumenstein

    Not yet recruiting

  • Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen

    Hamburg

    Stefanie Howaldt, MD

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover

    Ursula Seidler, MD

    Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg

    Annika Gauss, MD

    Not yet recruiting

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel

    Stefan Schreiber, MD

    Recruiting

  • St. Marienkrankenhaus

    Ludwigshafen

    Tanja Kuehbacher, MD

    Recruiting

  • LMU - Campus Grosshadern

    München

    Helga Toeroek, MD

    Not yet recruiting

  • Universitaetsklinikum Ulm

    Ulm

    Jochen Klaus, MD

    Recruiting

Other trials in Germany

Italy9 sites, 9 recruiting

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna

    Paolo Gionchetti, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Renato Dulbecco di Catanzaro

    Catanzaro

    Francesco Luzza, MD

    Not yet recruiting

  • Ospedale San Raffaele

    Milan

    Silvio Danese, MD

    Recruiting

  • Ospedale Sacro Cuore Don Calabria

    Negrar

    Angela Variola, MD

    Not yet recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

    Antonio Di Sabatino, MD

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma

    Antonio Gasbarrini, MD

    Recruiting

  • Università Campus Bio-Medico di Roma

    Roma

    Michele Cicala, MD

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano

    Alessandro Armuzzi, MD

    Recruiting

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

    Fabrizio Bossa, MD

    Recruiting

Other trials in Italy

Hungary8 sites, 8 recruiting

  • Bekes Varmegyei Kozponti Korhaz

    Békéscsaba

    Marta Varga, MD

    Recruiting

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest

    Robert Sike, MD

    Not yet recruiting

  • Pannonia Maganorvosi Centrum

    Budapest

    Robert Schnabel, MD

    Recruiting

  • Semmelweis Egyetem

    Budapest

    Pal Miheller, MD

    Recruiting

  • Semmelweis Egyetem

    Budapest

    Zsolt Tulassay, MD

    Not yet recruiting

  • Gyongyosi Bugat Pal Korhaz

    Gyöngyös

    Gabor Makai, MD

    Not yet recruiting

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár

    Roland Fejes, MD

    Recruiting

  • Clinfan Szolgaltato Kft.

    Szekszárd

    Agnes Salamon, MD

    Not yet recruiting

Other trials in Hungary

Spain8 sites, 8 recruiting

  • Centro Medico Teknon

    Barcelona

    Miquel Sans Cuffi, MD

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba

    Eva Maria Iglesias Flores

    Not yet recruiting

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada

    Fernando Bermejo San Jose, MD

    Not yet recruiting

  • Hospital General Juan Ramon Jimenez

    Huelva

    Elena Gomez Delgado, MD

    Recruiting

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria

    Daniel Sebastian Ceballos Santos, MD

    Recruiting

  • Clinica Gaias - Santiago

    Santiago de Compostela

    Ana Alvarez Castro, MD

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville

    Eduardo Leo Carnerero, MD

    Not yet recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia

    Carles Suria Bolufer, MD

    Not yet recruiting

Other trials in Spain

Belgium6 sites, 6 recruiting

  • Hopital Universitaire de Bruxelles - Hopital Erasme

    Brussels

    Denis Franchimont, MD

    Recruiting

  • AZ Maria Middelares

    Ghent

    Nele Deprez, MD

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent

    Triana Lobaton Ortega, MD

    Not yet recruiting

  • UZ Leuven

    Leuven

    Bram Verstockt, MD

    Recruiting

  • Centre Wallonie Picarde

    Tournai

    Lena Capirchio, MD

    Not yet recruiting

  • CHU UCL Namur

    Yvoir

    Jean-François Rahier, MD

    Recruiting

Other trials in Belgium

Czechia6 sites, 6 recruiting

  • SurGal Clinic s.r.o.

    Brno

    Jan Ulbrych, MD

    Recruiting

  • Vojenska nemocnice Brno

    Brno

    David Stepek, MD

    Recruiting

  • Hepato-Gastroenterologie HK s.r.o.

    Hradec Králové

    Miroslava Volfova, MD

    Not yet recruiting

  • PreventaMed s.r.o.

    Olomouc

    Jiri Pumprla, MD

    Recruiting

  • ISCARE a.s.

    Prague

    Milan Lukas, MD

    Not yet recruiting

  • Nemocnice Slany

    Slaný

    Martin Peterka, MD

    Recruiting

Other trials in Czechia

Slovakia6 sites, 6 recruiting

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta

    Banská Bystrica

    Jozef Balaz, MD

    Recruiting

  • Cliniq s.r.o.

    Bratislava

    Tibor Hlavaty, MD

    Recruiting

  • Endomed, s.r.o.

    Košice

    Miroslav Fedurco, MD

    Recruiting

  • KM Management spol. s r.o.

    Nitra

    Milos Gregus, MD

    Recruiting

  • Gastro I, s.r.o.

    Prešov

    Bohus Bunganic, MD

    Recruiting

  • Penta hospitals SK, a.s.

    Rimavská Sobota

    Jan Zachar, MD

    Recruiting

Other trials in Slovakia

Netherlands5 sites, 5 recruiting

  • Amsterdam UMC, Locatie AMC

    Amsterdam

    Geert D'Haens, MD

    Recruiting

  • Maastricht University Medical Center

    Maastricht

    Marieke Pierik, MD

    Not yet recruiting

  • Radboud UMC

    Nijmegen

    Marjolijn Duijvestein, MD

    Not yet recruiting

  • ETZ Elisabeth

    Tilburg

    Maurice Lutgens, MD

    Recruiting

  • Bernhoven Uden

    Uden

    Moniek Gorter, MD

    Not yet recruiting

Other trials in Netherlands

Romania5 sites, 5 recruiting

  • S.C Delta Health Care S.R.L

    Bucharest

    Camelia Chioncel, MD

    Recruiting

  • SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie

    Bucharest

    Theodor Alexandru Voiosu, MD

    Recruiting

  • Spitalul Clinic Colentina

    Bucharest

    Radu-Bogdan Mateescu, MD

    Not yet recruiting

  • S.C Pelican Impex S.R.L

    Oradea

    Alin-Horea Suta, MD

    Not yet recruiting

  • Valahia Medical SRL

    Ploieşti

    George Stancu, MD

    Recruiting

Other trials in Romania

About this study

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

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.

Being tested
Obefazimod, Placebo
Keywords
Crohn Disease
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObefazimodDrug

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

  • PlaceboOther

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

Study groups in NCT06456593
Study groupRoleWhat they receive
Obefazimod 50mgExperimentalObefazimod 50mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Receives: Drug: Obefazimod
Obefazimod 25mgExperimentalObefazimod 25mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Receives: Drug: Obefazimod
Obefazimod 12.5mgExperimentalObefazimod 12.5mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Receives: Drug: Obefazimod
PlaceboPlacebo comparatorPlacebo given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12 and week 52

  2. 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

    Measured: Week 52

  3. Maintenance Phase Efficacy - Endoscopic response

    Proportion of subjects with endoscopic response at Week 52

    Measured: Week 52

  4. 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

    Measured: Week 52

  5. 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

    Measured: Week 52

  6. Maintenance Phase Efficacy - PRO-2 clinical remission

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

    Measured: Week 52

  7. Maintenance Phase Efficacy - CDAI clinical response

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

    Measured: Week 52

  8. 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

    Measured: Week 52

  9. Maintenance Phase Efficacy - CDAI clinical response and endoscopic response

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

    Measured: Week 52

  10. Maintenance Phase Efficacy - endoscopic remission

    Proportion of subjects with endoscopic remission at Week 52

    Measured: Week 52

  11. 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

    Measured: Weeks 64, 76, 88,100 and EOS

  12. 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

    Measured: Weeks 64, 76, 88,100 and EOS

  13. 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)

    Measured: Weeks 64, 76, 88,100 and EOS

Secondary outcomes (9)

  1. Induction Phase Efficacy - SES-CD

    Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 12

    Measured: Week 12

  2. Induction Phase Efficacy - Endoscopic response

    Proportion of subjects with endoscopic response at Week 12

    Measured: Week 12

  3. Induction Phase Efficacy-SES-CD ulcer subscore > 1

    Proportion of subjects with no SES-CD ulcer subscore > 1 in at least one segment at Week 12

    Measured: Week 12

  4. Induction Phase Efficacy-CDAI clinical remission

    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

    Measured: Week 12

  5. Induction Phase Efficacy-PRO-2 clinical remission

    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

    Measured: Week 12

  6. Induction Phase Efficacy-CDAI clinical response

    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

    Measured: Week 12

  7. Induction Phase Efficacy-PRO-2 clinical response

    Proportion of subjects with PRO-2 clinical response at Week 12

    Measured: Week 12

  8. Induction Phase Efficacy-CDAI clinical response and endoscopic response

    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.

    Measured: Week 12

  9. Induction Phase Efficacy - endoscopic remission

    Proportion of subjects with endoscopic remission at Week 12

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start30 Oct 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06456593
Sponsor's protocol ID
ABX464-202
Acronym
ENHANCE-CD
Status last verified
Apr 2026
First submitted
16 May 2024
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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