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
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].
Status | Recruiting |
Enrollment | 612 |
Est. completion date | June 2024 |
Est. primary completion date | May 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 > 90 days prior to baseline, confirmed by endoscopy and histology. Should histology results not be available at screening, results from 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 therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA is not accepted). - Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods - 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 ulcerative colitis limited to an isolated proctitis (= 15cm from anal verge). - Subjects with primary sclerosing cholangitis or autoimmune hepatitis. - Subjects who have failed on 5-ASA 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 colon cancer, past or current evidence of low grade or high grade colonic dysplasia and/or adenomatous polyps that have not been completely removed. - Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma. - Subjects on antidiarrheals (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 < 50 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, or with opportunistic infection within the last 2 months prior to screening. - 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 section 5.3.8.1 of 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). - History or active malignancy (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. - Pregnant or breast-feeding women. - 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. - Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Italiano de Buenos Aires | Ciudad Autonoma Buenos Aires | |
Argentina | STAT Research S.A. | Ciudad Autonoma Buenos Aires | |
Argentina | Hospital Privado Centro Medico de Cordoba S.A | Córdoba | Cordoba |
Argentina | Hospital Italiano de La Plata | La Plata | 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 | Mater Hospital Brisbane | South Brisbane | Queensland |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Austria | LKH - Universitaetsklinikum Graz | Graz | |
Austria | Medizinische Universität Innsbruck | Innsbruck | |
Austria | Ordensklinikum Linz GmbH - Barmherzige Schwestern | Linz | |
Austria | LKH - Universitätsklinikum der PMU Salzburg | Salzburg | |
Austria | KH der Barmherzigen Brüder St.Veit an der Glan | St Veit an der Glan | |
Austria | AKH - Medizinische Universität Wien | Vienna | |
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 | Gastroenterology and Internal Medicine Research Institute | Edmonton | Alberta |
Canada | Montreal General Hospital | Montréal | Quebec |
Canada | Scott Shulman Medicine Professional Corporation | North Bay | Ontario |
Canada | Toronto Immune & Digestive Health Institute | North York | 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 First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang |
China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | The First Affiliated Hospital of University of South China | Hengyang | Hunan |
China | Jinan Central Hospital | Jinan | Shandong |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | The Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan |
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 | Affiliated hospital of Tsingdao medical college | Qingdao | Shandong |
China | Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch | Shanghai | Shanghai |
China | Shanghai General Hospital | Shanghai | Shanghai |
China | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
China | Shengjing Hospital of China Medical University | Shengyang | Liaoning |
China | Taian City Central Hospital | Tai'an | Shandong |
China | Renmin Hospital, Wuhan University | Wuhan | Hubei |
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei |
China | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
China | Yijishan Hospital of Wannan Medical College | Wuhu | Anhui |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
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 |
Germany | LMU - Campus Grosshadern | Muenchen | Bayern |
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 | Nil Ratan Sircar Medical College | Kolkata | West Bengal |
India | Chhatrapati Shahuji Maharaj (CSM) Medical University | Lucknow | Uttar Pradesh |
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 | Sahyadri Specialty Hospital | Pune | Maharashtra |
India | Shree Giriraj Multispeciality Hospital | Rajkot | Gujarat |
India | Unity Hospital ICU and Trauma | Surat | Gujarat |
Italy | Fondazione Poliambulanza Istituto Ospedaliero | Brescia | |
Italy | Azienda Ospedaliera Giuseppe Brotzu | Cagliari | |
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 | Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) | Pisa | |
Italy | I.R.C.C.S Policlinico San Donato | San Donato Milanese | Milano |
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 Lisboa Norte, E.P.E. - Hospital de Santa Maria | Lisboa | |
Portugal | Hospital da Luz | Lisboa | |
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 | Ankara City Hospital | Ankara | |
Turkey | Gazi University Medical Faculty | Ankara | |
Turkey | Antalya Training and Research Hospital | Antalya | |
Turkey | Acibadem Kozyatagi Hospital | Istanbul | |
Turkey | Koc University Hospital | Istanbul | |
Turkey | Medicana Kadikoy Hospital | Istanbul | |
Turkey | Ege University Medical Faculty | Izmir | |
Turkey | Kocaeli Universitesi Tip Fakultesi | Kocaeli | |
Turkey | Inonu University Gastroenterology | Malatya | |
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 | Northwestern University Feinberg School of Medicine | 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 | Baylor College Of Medicine | Houston | Texas |
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 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
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 | University of Washington | Seattle | Washington |
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 | University of Arizona | Tucson | Arizona |
United States | GI Alliance - Webster | Webster | Texas |
United States | TPMG Clinical Research Williamsburg | Williamsburg | Virginia |
United States | Wilmington Health | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Abivax S.A. |
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,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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Phase 1/Phase 2 | |
Recruiting |
NCT04398550 -
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
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N/A | |
Recruiting |
NCT04314375 -
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
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Phase 4 | |
Active, not recruiting |
NCT04857112 -
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
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Phase 2 | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
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Active, not recruiting |
NCT04033445 -
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
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Phase 2/Phase 3 | |
Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
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Active, not recruiting |
NCT06221995 -
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
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Recruiting |
NCT04767984 -
Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
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Phase 2 | |
Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
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N/A | |
Recruiting |
NCT06071312 -
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
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Phase 1/Phase 2 | |
Completed |
NCT03760003 -
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
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Phase 2 | |
Not yet recruiting |
NCT05539625 -
Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis
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Phase 2 |