ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

Ulcerative Colitis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507216
• Other study ID #: ABX464-106
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2022
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Abivax S.A.
• Contact: Sharon Skare, CPhil
• Phone: +33153830961
• Email: sharon.skare[@]abivax.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 612
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects = 18 years old will be enrolled. To be eligible, adolescent subjects must weigh = 40 kg and meet the definition of Tanner Stage 5 at the screening visit.

• Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.

• Documented diagnosis of UC confirmed by endoscopy and histology. Should endoscopy/histology results not be available at screening, results from endoscopies and biopsies taken at screening may be used.

• Active disease defined by modified Mayo score (MMS) = 5 with rectal bleeding subscore (RBS) = 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).

• Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic or biosimilar therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA or sulfasalazine is not accepted).

• Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with the contraception requirements described in the protocol.

• Subjects able and willing to comply with study visits and procedures as per protocol.

• Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.

Exclusion Criteria:

• Subjects with UC limited to an isolated proctitis (= 15cm from anal verge) determined by endoscopy central reading.

• Subjects with primary sclerosing cholangitis or autoimmune hepatitis.

• Subjects who have failed on 5-ASA or sulfasalazine therapy only.

• Subjects with CD or presence or history of fistula, indeterminate colitis, infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis).

• History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.

• History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of colonic cancer or evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not).

• Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.

• Subjects on antidiarrheals including those working on motility (e.g., loperamide, diphenoxylate with atropine, etc.).

• Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii).

• Subjects who do not meet the washout period requirements prior to the screening endoscopy.

• Subjects with the following hematological and biochemical laboratory parameters obtained during the screening period:

• Hemoglobin = 8.0 g dL-1

• Absolute neutrophil count < 750 mm-3

• Platelets < 100,000 mm-3

• Creatinine clearance < 60 mL.min-1 (Cockroft-Gault formula)

• Total serum bilirubin > 1.5 x ULN

• Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN

• Subjects with the following conditions (infection):

• Subjects with chronic or recurrent grade 3 or grade 4 infection within the last 2 months prior to screening or a history of opportunistic infection while not on immunosuppressive therapy.

• Herpes zoster reactivation within the last 2 months prior to screening.

• Subjects with active infection at screening or any major episode of infection that required hospitalization or treatment with intravenous 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) or positive test for Clostridium difficile toxin at screening. If C. difficile is positive, subject may be treated and retested = 2 weeks after completing treatment.

• Subjects with HIV infection.

• Subjects having 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 HBV DNA, or detectable HBV DNA).

• Subjects having acute or chronic hepatitis C infection at screening 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 are ruled out. For subjects with positive or intermediate QuantiFERON test see the current study protocol.

• Subjects with an uncontrolled ischemic heart disease and/or a history of congestive heart failure with New York Heart Association (NYHA) class 3 or 4 symptoms.

• Subjects with a family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval [Fridericia or Bazett correction] >450 milliseconds for male and > 460 milliseconds for female).

• Subjects with a history of torsade de pointe (TdP).

• Acute or chronic of clinically relevant pulmonary, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history (note: treated autoimmune hypothyroidy and autoimmune diabetes are allowed).

• Acute or chronic pancreatitis, determined by amylase and/or lipase elevations = 3 ULN at screening and abnormal imaging results (CT, MRI, or ultrasound) during the screening period

• History or active malignancy including non-melanoma skin cancer (subjects with a 5-year disease free survival are eligible).

• Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare).

• Subjects previously treated with ABX464.

• Subjects with a known hypersensitivity to the active substance or to any of the excipients.

• 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.

• Illicit drug or alcohol abuse or dependence.

• Subjects who received live vaccine within 3 months prior to screening and/or who's planning to receive such a vaccine during the study duration.

• Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer, and during the study.

• Subjects 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• ABX464
Administered once daily in the morning with food
• Placebo
Administered once daily in the morning with food

Locations

Country	Name	City	State
Argentina	CEMIC	Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Hospital Britanico de Buenos Aires	Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Gastroenterología Diagnóstica y Terapéutica (Gedyt)	Ciudad Autonoma Buenos Aires
Argentina	Centro de Investigacion CICE	San Miguel De Tucumán	Tucuman
Argentina	Centro de Investigaciones Medicas Tucuman	San Miguel De Tucumán	Tucuman
Belgium	GZA Ziekenhuizen	Antwerpen
Belgium	AZ Maria Middelares	Gent
Belgium	AZ Sint-Lucas	Gent
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	AZ Delta	Roeselare
Brazil	UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu	Botucatu	Sao Paulo
Brazil	L2IP - Instituto de Pesquisas Clínicas Ltda.	Brasília	Distrito Federal
Brazil	Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)	Caxias Do Sul	Rio Grande Do Sul
Brazil	CDC - Centro Digestivo de Curitiba	Curitiba	Paraná
Brazil	HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará	Fortaleza	Ceará
Brazil	CECIP - Centro de Estudos Clínicos do Interior Paulista	Jaú	Sao Paulo
Brazil	Hospital Ernesto Dornelles	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Aliança	Salvador	Bahia
Brazil	Faculdade de Medicina do ABC	Santo André	Sao Paulo
Brazil	Pesquisare Saúde	Santo André	Sao Paulo
Brazil	Praxis Pesquisa Medica	Santo André	Sao Paulo
Brazil	Irmandade da Santa Casa da Misericórdia de Santos	Santos	Sao Paulo
Brazil	Centro Multidisciplinar de Estudos Clínicos - CEMEC	São Bernardo	Sao Paulo
Brazil	Hepatogastro	São Paulo	Sao Paulo
Bulgaria	DCC 'Sv. Pantaleymon' OOD	Pleven
Bulgaria	Diagnostic Consultation Center CONVEX EOOD	Sofia
Bulgaria	MC Medica Plus	Veliko Tarnovo
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal	Montréal	Quebec
Canada	(G.I.R.I.) GI Research Institute	Vancouver	British Columbia
Croatia	General Hospital "Dr.Tomislav Bardek" Koprivnica	Koprivnica
Croatia	Poliklinika Borzan d.o.o	Osijek
Croatia	General Hospital Zadar	Zadar
Croatia	Solmed Polyclinic	Zagreb
Croatia	University hospital centre Zagreb	Zagreb
Czechia	Fakultni nemocnice Ostrava	Ostrava
Czechia	Institut klinicke a experimentalni mediciny	Praha
Czechia	Krajska nemocnice T. Bati a.s.	Zlín
France	CHU Amiens - Hopital Sud	Amiens	Somme
France	CHU Caen - Hôpital de la Côte de Nacre	Caen	Calvados
France	CHU de Grenoble - Hôpital Nord	Grenoble	Isere
France	Centre Hospitalier Départemental Les Oudairies	La Roche-sur-Yon	Vendée
France	CHU Lille - Hôpital Claude Huriez	Lille	Nord
France	Hôpital Nord - CHU Marseille	Marseille	Bouches-du-Rhône
France	Institut des MICI	Neuilly	Hauts De Seine
France	CHU Nice - Hôpital de l'Archet 2	Nice	Alpes Maritimes
France	Centre Hospitalier Lyon Sud	Pierre-Bénite	Rhone
France	CHU Rennes - Hôpital Pontchaillou	Rennes	Ille Et Vilaine
France	Hopital Rangueil	Toulouse	Haute Garonne
France	Hospital de brabois	Vantoux	Moselle
Germany	Universitaetsklinikum Augsburg	Augsburg	Bayern
Germany	Charité - Campus Charité Mitte	Berlin
Germany	DRK Kliniken Berlin Westend	Berlin
Germany	Krankenhaus Waldfriede e. V.	Berlin
Germany	Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen	Hamburg
Germany	INLUGA im Haus der Gesundheit	Ludwigshafen	Rheinland Pfalz
Germany	Medius Klinik Nuertingen	Nürtingen	Baden Wuerttemberg
Germany	Universitaetsklinikum Tuebingen	Tuebingen	Baden Wuerttemberg
Hungary	Semmelweis Egyetem	Budapest
Hungary	Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont	Debrecen
Hungary	Obudai Egeszsegugyi Centrum Kft.	Dunaujvaros
Hungary	Gyongyosi Bugat Pal Korhaz	Gyöngyös
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvár
Hungary	Clinfan Szolgaltato Kft.	Szekszárd
India	Postgraduate Institute of Medical Education and Research	Chandigarh
India	SRM Institutes for Medical Sciences	Chennai	Tamilnadu
India	Lakeshore Hospital and Research Centre Ltd.	Cochin	Kerala
India	Origin Hospital	Hyderabad	Andhra Pradesh
India	Yashoda Super Speciality Hospital	Hyderabad	Andhra Pradesh
India	Institute of Post Graduate Medical Education And Research	Kolkata	West Bengal
India	Vinaya Hospital and Research Center	Mangalore	Karnataka
India	Lokmanya Tilak Municipal General Hospital & Medical College	Mumbai	Maharashtra
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Fortis Escorts Heart Institute and Research Centre	New Delhi	Delhi
India	Maharaja Agrasen Hospital	New Delhi	Delhi
India	Gandhi Hospital	Secunderabad	Andhra Pradesh
India	Gujarat Hospital	Surat	Gujarat
India	Surat Institute of Digestive Sciences	Surat	Gujarat
India	Isha Multispeciality Hospital	Vadodara	Gujarat
India	Datta Meghe Institute of Medical Sciences (Deemed University)	Wardha	Maharashtra
Ireland	Connolly Hospital	Dublin
Ireland	Portiuncula Hospital	Galway
Ireland	University Hospital Galway	Galway
Ireland	Our Lady of Lourdes	Louth
Ireland	Midland Regional Hospital	Mullingar	Westmeath
Israel	HaEmek Medical Center	Afula
Israel	Soroka University Medical Center	Be'er Sheva
Israel	Bnai Zion Medical Center	Haifa
Israel	Carmel Medical Center	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center-Beilinson Campus	Petah tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center KMC Institute of Gastroenterology and Liver Diseases	Re?ovot
Italy	Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS	Bologna
Italy	Azienda Ospedaliero Universitaria Mater Domini	Catanzaro
Italy	Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)	Milano
Italy	Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"	Napoli
Italy	Ospedale di Circolo	Rho	Milano
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma
Italy	Università Campus Bio-Medico di Roma	Roma
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Japan	Fukuoka University Chikushi Hospital	Chikushino-shi	Fukuoka-Ken
Japan	Shinseikai Sai Gastroenterology, Proctology Clinic	Fujiidera	Osaka-Fu
Japan	NHO Fukuyama Medical Center	Fukuyama-shi	Hiroshima-Ken
Japan	Matsuaikai Matsuda Hospital	Hamamatsu-shi	Shizuoka-Ken
Japan	JA-Hiroshima General Hospital	Hatsukaichi-shi	Hiroshima-Ken
Japan	Hiroshima Prefectural Hospital	Hiroshima-shi	Hiroshima-Ken
Japan	NHO Mito Medical Center	Ibaraki	Ibaraki-Ken
Japan	Aso Co.,Ltd Iizuka Hospital	Iizuka-shi	Fukuoka-Ken
Japan	Jiaikai Izuro Imamura Hospital	Kagoshima-shi	Kagoshima-Ken
Japan	Kagoshima IBD Gastroenterology Clinic	Kagoshima-shi	Kagoshima-Ken
Japan	Sameshima Hospital	Kagoshima-shi	Kagoshima-Ken
Japan	Gokeikai Ofuna Chuo Hospital	Kamakura-shi	Kanagawa-Ken
Japan	NHO Kanazawa Medical Center	Kanazawa-shi	Ishikawa-Ken
Japan	Kokikai Tsujinaka Hospital Kashiwanoha	Kashiwa-shi	Chiba-Ken
Japan	Kawasaki Municipal Hospital	Kawasaki-shi	Kanagawa-Ken
Japan	Kiryu Kosei General Hospital	Kiryu-shi	Gunma-Ken
Japan	Aoyama Clinic	Kobe-shi	Hyogo-Ken
Japan	Showa University Koto Toyosu Hospital	Koto-ku	Tokyo-To
Japan	Kumagaya General Hospital	Kumagaya-shi	Saitama-Ken
Japan	Kaiseikai Hattori Clinic	Kumamoto-shi	Kumamoto-Ken
Japan	NHO Kure Medical Center and Chugoku Cancer Center	Kure-shi	Hiroshima-Ken
Japan	Kurume University Hospital	Kurume-shi	Fukuoka-Ken
Japan	Our Lady of the Snow St. Mary's Hospital	Kurume-shi	Fukuoka-Ken
Japan	Ehime Prefectural Central Hospital	Matsuyama-shi	Ehime-Ken
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo-To
Japan	Saiseikai Niigata Hospital	Niigata-shi	Niigata-Ken
Japan	Ishida Clinic of IBD and Gastroenterology	Oita-shi	Oita-Ken
Japan	NHO Okayama Medical Center	Okayama-shi	Okayama-Ken
Japan	Okayama University Hospital	Okayama-shi	Okayama-Ken
Japan	Keiaikai Nakagami Hospital	Okinawa-shi	Okinawa-Ken
Japan	JCHO Osaka Hospital	Osaka-shi	Osaka-Fu
Japan	Kinshukai Infusion Clinic	Osaka-shi	Osaka-Fu
Japan	NHO Osaka National Hospital	Osaka-shi	Osaka-Fu
Japan	SUBARU Health Insurance Society Ota Memorial Hospital	Ota-shi	Gunma-Ken
Japan	Saga University Hospital	Saga-shi	Saga-Ken
Japan	Saga-Ken Medical Centre Koseikan	Saga-shi	Saga-Ken
Japan	JCHO Hokkaido Hospital	Sapporo-shi	Hokkaido
Japan	JCHO Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo-To
Japan	Kagawa Prefectural Central Hospital	Takamatsu-shi	Kagawa-Ken
Japan	Takamatsu Red Cross Hospital	Takamatsu-shi	Kagawa-Ken
Japan	Toyohashi Municipal Hospital	Toyohashi	Aichi-Ken
Japan	Mie University Hospital	Tsu-shi	Mie-Ken
Japan	NHO Ureshino Medical Center	Ureshino-shi	Saga-Ken
Japan	Showa University Northern Yokohama Hospital	Yokohama-shi	Kanagawa-Ken
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas
Lithuania	Lithuanian University of Health Sciences Kaunas Hospital	Kaunas
Lithuania	Klaipeda University Hospital branch "Seamen's Hospital"	Klaipeda
Mexico	Consultorio Medico, InvesclinicMX	Irapuato	Guanajuato
Mexico	Accelerium S de RL de CV	Monterrey	Nuevo León
Mexico	Inspirepharma S. de R.L. de C.V.	Monterrey	Nuevo León
Mexico	FAICIC S. de R.L. de C.V.	Veracruz
Mexico	Sociedad de Metabolismo y Corazon S.C	Veracruz
New Zealand	Christchurch Hospital NZ	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Auckland City Hospital	Grafton
New Zealand	Waikato Hospital	Hamilton
New Zealand	Tauranga Hospital	Tauranga
Poland	NZOZ Centrum Medyczne KERmed	Bydgoszcz
Poland	Centrum Medyczne Pratia Gdynia	Gdynia
Poland	Trialmed CRS	Kalisz
Poland	ETG Kielce Zagorska	Kielce
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla	Knurów
Poland	Centrum Medyczne Plejady	Kraków
Poland	1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie	Lublin
Poland	ALLMEDICA sp. z o. o.	Nowy Targ
Poland	Wojewodzki Specjalistyczny Szpital w Olsztynie	Olsztyn
Poland	Medicome Sp. z o.o.	Oswiecim
Poland	Gabinet Lekarski Bartosz Korczowski	Rzeszów
Poland	Nowe zdrowie-CK, Kieltucki i wspolnicy sp. j.	Staszów
Poland	DC-MED	Swidnica
Poland	Centrum Zdrowia Tuchow Sp. z o.o.	Wierzchoslawice
Romania	Spitalul de Oncologie Monza	Bucharest
Romania	Institutul Clinic Fundeni	Bucuresti
Romania	Institutul Clinic Fundeni	Bucuresti
Romania	Lotus Med SRL	Bucuresti
Romania	S.C Delta Health Care S.R.L	Bucuresti
Romania	S.C Policlinica CCBR S.R.L	Bucuresti
Romania	SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie	Bucuresti
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Cluj Napoca	Cluj-Napoca
Romania	Centrul Medical Renasterea Craiova	Craiova
Romania	S.C Pelican Impex S.R.L	Oradea
Romania	S.C Centrul Medical Valahia S.R.L	Ploiesti
Serbia	Clinical Center " Dr Dragisa Misovic Dedinje"	Belgrade
Serbia	Clinical Hospital Center Zvezdara	Belgrade
Serbia	General Hospital Subotica	Subotica
Slovakia	Accout Center s.r.o.	Šahy
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta	Banská Bystrica
Slovakia	Cliniq s.r.o.	Bratislava
Slovakia	Endomed, s.r.o.	Košice
Slovakia	Univerzitna nemocnica Martin	Martin
Slovakia	Fakultna nemocnica Nitra	Nitra
Slovakia	KM Management spol. s r.o.	Nitra
Slovakia	Gastro I, s.r.o.	Prešov
Slovakia	Gastro LM s.r.o.	Prešov
Slovakia	Svet zdravia a.s.	Rimavská Sobota
Spain	Centro Medico Teknon	Barcelona
Spain	Complejo Hospitalario Universitario de Ferrol	Ferrol	La Coruña
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitari de Girona Dr Josep Trueta	Girona
Spain	Hospital General Juan Ramon Jimenez	Huelva
Spain	Hospital Universitario de Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Las Palmas
Spain	Hospital Montecelo	Pontevedra
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire
United Kingdom	Royal Devon and Exeter Hospital (Wonford)	Exeter	Devon
United Kingdom	Guy's Hospital	London	Greater London
United States	University of Michigan	Ann Arbor	Michigan
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals	Aurora	Colorado
United States	National Institute of Clinical Research	Bakersfield	California
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Inquest Clinical Research	Baytown	Texas
United States	University of Alabama -Birmingham	Birmingham	Alabama
United States	NY Scientific Corp.	Brooklyn	New York
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	West Central Gastroenterology d/b/a Gastro Florida	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Iowa Digestive Disease Center	Clive	Iowa
United States	Kindred Medical Institute for Clinical Trials, LLC	Corona	California
United States	Citrus Valley Gastroenterology	Covina	California
United States	Danbury Hospital	Danbury	Connecticut
United States	NECCR Primacare Research, LLC	Fall River	Massachusetts
United States	Plains Clinical Research Center, LLC	Fargo	North Dakota
United States	Michigan Center of Medical Research	Farmington Hills	Michigan
United States	AIG Digestive Disease Research	Florham Park	New Jersey
United States	Gastrointestinal Associates, PA	Flowood	Mississippi
United States	Valley Institute of Research	Fort Worth	Texas
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Susquehanna Research Group, LLC	Harrisburg	Pennsylvania
United States	Digestive Health Research, LC	Hermitage	Tennessee
United States	Superior Associates in Research	Hialeah	Florida
United States	The University of Iowa	Iowa City	Iowa
United States	Mt.Olympus Medical Research	Katy	Texas
United States	IHS Health	Kissimmee	Florida
United States	BVL Clinical Research	Liberty	Missouri
United States	Research Solutions of Arizona, PC	Litchfield Park	Arizona
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Tandem Clinical Research, LLC	Marrero	Louisiana
United States	Infinite Clinical Research Inc	Miami	Florida
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Reliant Medical Research, LLC	Miami	Florida
United States	Research Associates of South Florida	Miami	Florida
United States	Sanchez Clinical Research, Inc	Miami	Florida
United States	United Medical Doctors	Murrieta	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Ocala GI Research	Ocala	Florida
United States	Sarkis Clinical Trials - Parent	Ocala	Florida
United States	Board of Regents of the University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Arnold Palmer Hospital For Children	Orlando	Florida
United States	Omega Research Orlando, LLC	Orlando	Florida
United States	Digestive System Healthcare	Pasadena	Texas
United States	LinQ Research, LLC	Pearland	Texas
United States	Valleywise Health Medical Center	Phoenix	Arizona
United States	Rapid City Medical Center, LLC	Rapid City	South Dakota
United States	Gastroenterology Consultants and Endoscopy Center of Southwest Virginia	Roanoke	Virginia
United States	Clinical Applications Laboratories	San Diego	California
United States	Reliance Research	Scottsdale	Arizona
United States	Alliance Clinical Research	Tampa	Florida
United States	GCP Clinical Research, LLC	Tampa	Florida
United States	Guardian Angel Research Center	Tampa	Florida
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Frontier Clinical Research, LLC	Uniontown	Pennsylvania
United States	The Vancouver Clinic	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Abivax S.A.

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Bulgaria,  Canada,  Croatia,  Czechia,  France,  Germany,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Lithuania,  Mexico,  New Zealand,  Poland,  Romania,  Serbia,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8	To compare the efficacy of ABX464 versus placebo on clinical remission	8 weeks
Secondary	Proportion of subjects who achieve endoscopic improvement at week 8	To compare the efficacy of ABX464 versus placebo on endoscopic improvement	8 weeks
Secondary	Proportion of subjects who achieve clinical response per MMS at week 8	To compare the efficacy of ABX464 versus placebo on clinical response as per MMS	8 weeks
Secondary	Proportion of subjects with symptomatic remission at week 8	To compare the efficacy of ABX464 versus placebo on symptomatic remission	8 weeks
Secondary	Proportion of subjects with HEMI per Geboes at week 8	To compare the efficacy of ABX464 versus placebo on histologic-endoscopic mucosal improvement (HEMI)	8 weeks