ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1

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: NCT05507203
• Other study ID #: ABX464-105
• Status: Recruiting
• Phase: Phase 3
• Start date: October 10, 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 weight = 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 or 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 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	Hospital Italiano de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	STAT Research S.A.	Ciudad Autonoma Buenos Aires
Argentina	Instituto de Investigaciones Clinicas Quilmes	Quilmes	Buenos Aires
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Blacktown Hospital	Blacktown	New South Wales
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Footscray Hospital	Footscray	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Coral Sea Clinical Research Institute	North Mackay	Queensland
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	LKH - Universitaetsklinikum Graz	Graz
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	LKH - Universitätsklinikum der PMU Salzburg	Salzburg
Austria	KH der Barmherzigen Brüder St.Veit an der Glan	St Veit an der Glan
Belgium	AZ Klina	Brasschaat
Belgium	AZ Sint-Lucas	Brugge
Belgium	C. H. U. St-Pierre	Bruxelles
Belgium	Universitair Ziekenhuis Brussel	Bruxelles
Belgium	UZ Leuven	Leuven
Belgium	Clinique CHC MontLégia	Liège
Belgium	CHU UCL Namur	Yvoir
Bulgaria	Medical center Medconsult Pleven OOD	Pleven
Bulgaria	DCC "Alexandrovska", EOOD	Sofia
Bulgaria	UMHAT 'Tsaritsa Yoanna - ISUL', EAD	Sofia
Bulgaria	UMHATEM 'N.I. Pirogov', EAD	Sofia
Bulgaria	UMHAT Prof. Dr. Stoyan Kirkovich AD	Stara Zagora
Canada	Scott Shulman Medicine Professional Corporation	North Bay	Ontario
Canada	Kensington Screening Clinic	Toronto	Ontario
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	The First Hospital of Jilin University	Changchun	Jilin
China	The 2nd Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	Army Specialty Medical Center of The Chinese People's Liberation Army	Chongqing	Sichuan
China	The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force	Fuzhou	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Jiangxi Gannan Medical College Affiliated 1 st Hospital	Ganzhou	Jiangxi
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	General Hospital of Eastern Theater Command	Nanjing	Jiangsu
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Shanghai General Hospital	Shanghai	Shanghai
China	Taian City Central Hospital	Tai'an	Shandong
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Yijishan Hospital of Wannan Medical College	Wuhu	Anhui
Czechia	CCR Brno, s.r.o.	Brno
Czechia	SurGal Clinic s.r.o.	Brno
Czechia	Hepato-Gastroenterologie HK s.r.o.	Hradec Králové
Czechia	PreventaMed s.r.o.	Olomouc
Czechia	CCR Ostrava s.r.o.	Ostrava
Czechia	Nemocnice Slany	Slaný
France	CHU Besançon - Hôpital Jean Minjoz	Besançon	Doubs
France	CHU Clermont Ferrand - Hopital d'Estaing	Clermont-Ferrand	Puy De Dome
France	Hôpital Henri Mondor	Créteil	Val De Marne
France	CHU Dijon - Hôpital Bocage Central	Dijon	Cote D'or
France	Hôpital Bicêtre	Le Kremlin-Bicêtre	Val De Marne
France	Hopital Saint Eloi	Montpellier	Herault
France	CHU Nantes - Hôtel Dieu	Nantes	Loire Atlantique
France	Hôpital Saint-Louis	Paris
France	Centre Hospitalier de Pau - Hôpital François Mitterrand	Pau	Pyrénées Atlantique
France	CHU Bordeaux - Hôpital Haut-Lévêque	Pessac	Gironde
France	CHU Reims - Hôpital Robert Debré	Reims	Ardennes
France	CHU Saint Etienne - Hôpital Nord	Saint-Étienne	Loire
Germany	Charité - Campus Benjamin Franklin	Berlin
Germany	Gastroenterologie Berlin Karlshorst	Berlin
Germany	Staedisches Klinikum Brandenburg	Brandenburg an der Havel	Brandenburg
Germany	Universitaetsklinikum Erlangen	Erlangen	Bayern
Germany	Universitaetsklinikum Frankfurt Goethe-Universitaet	Frankfurt	Hessen
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt	Heidelberg	Baden Wuerttemberg
Germany	Universitaetsklinikum Heidelberg	Heidelberg	Baden Wuerttemberg
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Kiel	Kiel	Schleswig Holstein
Greece	University General Hospital of Alexandroupolis	Alexandroupolis
Greece	General Hospital of Athens "Evangelismos"	Athens
Greece	Corfu General Hospital "St. Eirini"	Corfu
Greece	University General Hospital of Heraklion	Heraklion
Greece	General Hospital of Thessaloniki "Hippokration"	Thessaloníki
Hungary	Bekes Varmegyei Kozponti Korhaz	Békéscsaba
Hungary	Clinexpert Kft.	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz	Szombathely
India	Navneet Memorial Hospital 'Sushrusha'	Ahmedabad	Gujarat
India	M. S. Ramaiah Medical College and Hospital	Bangalore	Karnataka
India	K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre	Belagave	Karnataka
India	Amrita Institute Of Medical Sciences and Research Centre	Cochin	Kerala
India	Fortis Memorial Research Institute	Gurgaon	Haryana
India	S. R. Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	Dayanand Medical College and Hospital	Ludhiana	Punjab
India	King Edward Memorial Hospital Research Centre	Mumbai	Maharashtra
India	Midas Multispeciality Hospital Pvt Ltd	Nagpur	Maharashtra
India	Chopda Medicare & Research Centre	Nashik	Maharashtra
India	Ruby Hall Clinic	Pune	Maharashtra
India	Shree Giriraj Multispeciality Hospital	Rajkot	Gujarat
India	Unity Hospital ICU and Trauma	Surat	Gujarat
Italy	Fondazione Poliambulanza Istituto Ospedaliero	Brescia
Italy	Presidio Ospedaliero Garibaldi Nesima	Catania
Italy	Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico	Milano
Italy	Ospedale San Raffaele	Milano
Italy	Ospedale Sacro Cuore Don Calabria	Negrar	Verona
Italy	Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello"	Palermo
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
Italy	Ospedale San Bortolo di Vicenza	Vicenza
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Hospital	Daegu	Gyeongsangbuk-do
Korea, Republic of	The Catholic University of Korea, Daejeon St. Mary's Hospital	Daejeon
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju	Gangwon-do
Netherlands	Amsterdam UMC, Locatie AMC	Amsterdam
Netherlands	Radboud UMC	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Netherlands	Zuyderland Medisch Centrum - Sittard-Geleen	Sittard
Netherlands	ETZ Elisabeth	Tilburg
Netherlands	Bernhoven Uden	Uden
Poland	Przychodnia Specjalistyczna Insula	Belchatow
Poland	Szpital Zakonu Bonifratow Sp. z o.o.	Katowice
Poland	Centrum Medyczne PROMED	Kraków
Poland	NZOZ Centrum Medyczne ProMiMed	Kraków
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Lecznej	Leczna
Poland	AMICARE spólka z ograniczona odpowiedzialnoscia spólka komandytowa	Lódz
Poland	Twoja Przychodnia Opolskie Centrum Medyczne	Opole
Poland	NSZOZ Termedica - Centrum Badan Klinicznych	Poznan
Poland	SOLUMED Centrum Medyczne	Poznan
Poland	Twoja Przychodnia PCM	Poznan
Poland	Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA	Sosnowiec
Poland	Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.	Szczecin
Poland	Centrum Zdrowia MDM	Warsaw
Poland	NZOZ VIVAMED Jadwiga Miecz	Warszawa
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	PlanetMed sp. z o.o.	Wroclaw
Poland	ETG Zamosc	Zamosc
Portugal	Hospital de Braga	Braga
Portugal	Hospital da Senhora da Oliveira Guimarães	Guimarães
Portugal	Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião	Santa Maria Da Feira
Portugal	Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE	Viana Do Castelo
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Reina Sofia	Córdoba	Cordoba
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Clinica Gaias - Santiago	Santiago De Compostela	La Coruña
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Switzerland	Claraspital	Basel
Switzerland	Inselspital - Universitaetsspital Bern	Bern
Switzerland	Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern	Bern
Switzerland	Universitaetsspital Zuerich	Zuerich
Turkey	Koc University Hospital	Istanbul
Turkey	Medicana Kadikoy Hospital	Istanbul
Turkey	Kocaeli Universitesi Tip Fakultesi	Kocaeli
Turkey	Mersin University Medical Faculty	Mersin
United Kingdom	The Ulster Hospital	Belfast
United Kingdom	Bury Care Organisation	Bury	Greater Manchester
United Kingdom	St Mark's Hospital	Harrow	Middlesex
United Kingdom	Huddersfield Royal Infirmary	Huddersfield	West Yorkshire
United Kingdom	Hammersmith Hospital	London	Greater London
United Kingdom	King's College Hospital	London	Greater London
United Kingdom	Yeovil District Hospital	Yeovil	Somerset
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	Central Texas Clinical Research, LLC	Austin	Texas
United States	GI Alliance - Southlake	Austin	Texas
United States	GI Alliance - Baton Rouge	Baton Rouge	Louisiana
United States	Boston Medical Center	Boston	Massachusetts
United States	Clinical Research Of Brandon, LLC	Brandon	Florida
United States	Access Research Institute	Brooksville	Florida
United States	Texas Digestive Disease Consultants	Cedar Park	Texas
United States	Charlotte Gastroenterology and Hepatology, P.L.L.C	Charlotte	North Carolina
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Eagle Clinical Research	Chicago	Illinois
United States	Gastro Health Research	Cincinnati	Ohio
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Columbia Digestive Health Research	Columbia	South Carolina
United States	Wexner Medical Center	Columbus	Ohio
United States	Aurora Care Clinic	Costa Mesa	California
United States	Baylor Scott and White	Dallas	Texas
United States	Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia
United States	Digestive Health Specialists of the Southeast	Dothan	Alabama
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	GI Alliance - Garland	Garland	Texas
United States	Gastroenterology Center of the MidSouth PC	Germantown	Tennessee
United States	GI Alliance	Glenview	Illinois
United States	Gastroenterology Associates, PA	Greenville	South Carolina
United States	Lakeview Clinical Research	Guntersville	Alabama
United States	GI Alliance	Gurnee	Illinois
United States	Biopharma Informatic, Inc. Research Center	Houston	Texas
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas
United States	Gastro Health & Nutrition	Katy	Texas
United States	Auzmer Research	Lakeland	Florida
United States	Gastro Care Institute	Lancaster	California
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	University of Louisville Research Foundation	Louisville	Kentucky
United States	Care Access Research Lumberton	Lumberton	North Carolina
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Cfagi, Llc	Maitland	Florida
United States	Medical Professional Clinical Research Center	Miami	Florida
United States	MedOne Clinical Research LLC	Miami	Florida
United States	Lucida Clinical Trials LLC	New Bedford	Massachusetts
United States	Advanced Research Institute, Inc.	New Port Richey	Florida
United States	One Health Research Clinic Atlanta, LLC	Norcross	Georgia
United States	California Medical Research Associates Inc.	Northridge	California
United States	Digestive Health Center PA	Ocean Springs	Mississippi
United States	Care Access Research LLC	Ogden	Utah
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Clinnova Research Solutions	Orange	California
United States	Advanced Research Institute, Inc.	Orlando	Florida
United States	Endoscopic Research, Inc.	Orlando	Florida
United States	Gastroenterology Associates of Pensacola, PA	Pensacola	Florida
United States	Rochester Clinical Research	Rochester	New York
United States	University of Utah	Salt Lake City	Utah
United States	GI Alliance - San Marcos	San Marcos	Texas
United States	Texas Gastroenterology Associates	Spring	Texas
United States	DSI Research LLC	Springboro	Ohio
United States	GI Alliance	Sun City	Arizona
United States	Theia Clinical Research Centers, LLC	Temple Terrace	Florida
United States	Del Sol Research Management, LLC	Tucson	Arizona
United States	GI Alliance - Webster	Webster	Texas
United States	TPMG Clinical Research Williamsburg	Williamsburg	Virginia
United States	Wilmington Health	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abivax S.A.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Hungary,  India,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Spain,  Switzerland,  Turkey,  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	8 weeks