Phase
Condition
Inflammatory Bowel Disease
Colic
Ulcerative Colitis
Treatment
Placebo
SAR442970
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Male or female participants aged 18 to 75 years inclusive, at the time of signingthe informed consent
Participants who have had clinical evidence of active UC for ≥3 months beforescreening and confirmed by endoscopy during the screening period
Must have active moderate-to-severe UC at screening as defined by a modified MayoScore (mMS) of 5 to 9 (without the Physician Global Assessment (PGA), with a minimumRectal Bleeding (RB) subscore ≥1, a minimum Stool Frequency (SF) subscore ≥1, mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a minimumdisease extent of 15 cm from the anal verge
Must have received prior treatment for UC (either "a" or "b" below or combination ofboth):
History of inadequate response to, loss of response to or intolerance tostandard treatment with any of the following compounds: amino-salicylates,corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or history ofcorticosteroid dependence (defined as an inability to successfully tapercorticosteroids without recurrence of UC) AND history of no prior exposure toAdvanced Therapies (ATs), such as a biologic agent used to treat UC or advancedsmall molecules used to treat UC
History of inadequate response to, loss of response to or intolerance totreatment with ≥1 approved AT such as a biologic agent used to treat UC oradvanced small molecules used to treat UC
- Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies
Exclusion
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Participants with active Crohn's Disease (CD), indeterminate colitis or microscopiccolitis
Participants with fecal sample positive for culture/ova for aerobic pathogens orpositive for Clostridium difficile B toxin in stools
Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomyduring their participation in the study
Participants with the following ongoing known complications of UC: fulminantdisease, toxic megacolon or colonic dysplasia except for adenoma
Participants with intestinal failure or short bowel syndrome requiring TotalParenteral Nutrition
History of recurrent or recent serious infection within 4 weeks of screening, orinfection(s) requiring hospitalization or treatment with IV anti-infectives within 30 days prior to baseline, or infections(s) requiring oral anti-infectives within 14days prior to baseline, except as required as part of an anti-Tuberculosis (TB)regimen
Known history of or suspected significant current immunosuppression.
History or solid organ transplant or splenectomy
History of moderate to severe congestive heart failure (New York Health AssociationClass III or IV), or recent cerebrovascular accident.
History of demyelinating disease (including myelitis) or neurologic symptomssuggestive of demyelinating disease
Participants with a history of malignancy or lymphoproliferative disease other thanadequately treated localized carcinoma in situ of the cervix or nonmetastaticsquamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin
Participants with a diagnosis of inflammatory conditions other than UC (includingbut not limited to systemic lupus erythematosus, systemic sclerosis, myositis,rheumatoid arthritis, primary biliary cirrhosis, multiple sclerosis, Behcet'sdisease, sarcoidosis, etc.)
History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology atScreening
History of Interstitial Lung Disease
Participants with any of the following results at Screening:
Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,
Positive total Hepatitis B core antibody (anti-HBc) confirmed by positiveHepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) or,
Positive Hepatitis C Virus (HCV) antibody
Screening laboratory and other analyses showing abnormal results
History of any other condition which, in the opinion of the Investigator, would putthe participant at risk by participation in the protocol
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Design
Connect with a study center
Investigational Site Number: 0360003
Brisbane, Queensland 4101
AustraliaActive - Recruiting
Investigational Site Number: 0360003
Brisbane 2174003, Queensland 2152274 4101
AustraliaSite Not Available
Mater Misericordiae Limited - Site Number: 0360003
Brisbane 2174003, Queensland 2152274 4101
AustraliaActive - Recruiting
Investigational Site Number: 0360001
Clayton, Victoria 3168
AustraliaActive - Recruiting
Investigational Site Number: 1560004
Huizhou, Ghangdong 516001
ChinaActive - Recruiting
Investigational Site Number: 1560005
Guangzhou, Guangdong 510655
ChinaActive - Recruiting
Investigative Site: 1560005
Guangzhou 1809858, Guangdong 1809935 510655
ChinaSite Not Available
Investigational Site Number: 1560002
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
Investigational Site Number: 1560008
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
Investigational Site Number: 1560003
Wuxi, Jiangsu 214023
ChinaActive - Recruiting
Investigative Site: 1560002
Nanjing 1799962, Jiangsu 1806260 210029
ChinaSite Not Available
Investigative Site: 1560008
Suzhou 1886760, Jiangsu 1806260 215006
ChinaSite Not Available
Investigative Site: 1560003
Wuxi 1790923, Jiangsu 1806260 214023
ChinaSite Not Available
Investigational Site Number: 1560001
Hangzhou, 310016
ChinaActive - Recruiting
Investigational Site Number: 1560001
Hangzhou 1808926, 310016
ChinaSite Not Available
Investigational Site Number: 1560007
Ningbo, 315010
ChinaActive - Recruiting
Investigational Site Number: 1560007
Ningbo 1799397, 315010
ChinaSite Not Available
Investigational Site Number: 2030001
Brno, JM 61500
CzechiaActive - Recruiting
Investigational Site Number: 2030001
Brno 3078610, JM 61500
CzechiaSite Not Available
Vojenska Nemocnice Brno - Site Number: 2030001
Brno 3078610, JM 61500
CzechiaActive - Recruiting
Investigational Site Number: 2030002
Slaný, 27401
CzechiaActive - Recruiting
Investigational Site Number: 2500002
Lille, 59037
FranceActive - Recruiting
Investigational Site Number: 2500002
Lille 2998324, 59037
FranceSite Not Available
Investigative Site: 2500006
Nice, 6200
FranceActive - Recruiting
Investigative Site: 2500006
Nice 2990440, 6200
FranceSite Not Available
Investigational Site Number: 2500005
Pierre-Bénite, 69495
FranceActive - Recruiting
Centre Hospitalier Lyon-Sud - Site Number: 2500005
Pierre-Bénite 2987314, 69495
FranceActive - Recruiting
Investigational Site Number: 2500005
Pierre-Bénite 2987314, 69495
FranceSite Not Available
Investigational Site Number: 2500001
Saint-Priest-en-Jarez, 42270
FranceActive - Recruiting
Investigational Site Number: 2500001
Saint-Priest-en-Jarez 2977350, 42270
FranceSite Not Available
Investigational Site Number: 2500003
Toulouse, 31400
FranceActive - Recruiting
Investigational Site Number: 2500003
Toulouse 2972315, 31400
FranceSite Not Available
Investigational Site Number: 2500004
Vandœuvre-lès-Nancy, 54500
FranceSite Not Available
Investigational Site Number: 2500004
Vandœuvre-lès-Nancy 2970797, 54500
FranceSite Not Available
Investigational Site Number: 2760001
Minden, Northwest 32423
GermanyActive - Recruiting
Gastroenterologische Gemeinschaftspraxis Minden - Site Number: 2760001
Minden 2871039, Northwest 32423
GermanyActive - Recruiting
Investigational Site Number: 2760001
Minden 2871039, Northwest 32423
GermanySite Not Available
Investigational Site Number: 2760005
Kiel, Schleswig-Holstein 24105
GermanyActive - Recruiting
Investigational Site Number: 2760005
Kiel 2891122, Schleswig-Holstein 2838632 24105
GermanySite Not Available
Universitatsklinikum Schleswig-Holstein - Site Number: 2760005
Kiel 2891122, Schleswig-Holstein 2838632 24105
GermanyActive - Recruiting
Investigational Site Number: 2760003
Ulm, 89081
GermanyActive - Recruiting
Investigational Site Number: 3480002
Budapest, 1088
HungaryActive - Recruiting
Investigational Site Number: 3480003
Budapest, 1066
HungaryActive - Recruiting
Investigational Site Number: 3480003
Budapest 3054643, 1066
HungaryActive - Recruiting
Investigative Site: 3480002
Budapest 3054643, 1088
HungarySite Not Available
Investigational Site Number: 3480001
Vác, 2600
HungaryActive - Recruiting
Investigational Site Number: 3480001
Vác 3043293, 2600
HungarySite Not Available
Investigational Site Number: 3920002
Kashiwa, Chiba 277-0871
JapanActive - Recruiting
Investigational Site Number: 3920002
Kashiwa 1859924, Chiba 2113014 277-0871
JapanSite Not Available
Tsujinaka Hospital-Kashiwanoha - Site Number: 3920002
Kashiwa 1859924, Chiba 2113014 277-0871
JapanActive - Recruiting
Investigational Site Number: 3920006
Ōita, Oita Prefecture 870-0033
JapanActive - Recruiting
Investigational Site Number: 3920006
Ōita 1854487, Oita Prefecture 1854484 870-0033
JapanSite Not Available
Oita Red Cross Hospital - Site Number: 3920006
Ōita 1854487, Oita Prefecture 1854484 870-0033
JapanActive - Recruiting
Investigational Site Number: 3920005
Hamamatsu, 431-3192
JapanActive - Recruiting
Investigational Site Number: 3920005
Hamamatsu 1863289, 431-3192
JapanSite Not Available
Investigational Site Number: 3920003
Hirosaki, 036-8545
JapanActive - Recruiting
Investigational Site Number: 3920003
Hirosaki 2130057, 036-8545
JapanSite Not Available
Investigational Site Number: 3920001
Morioka, 020-8505
JapanActive - Recruiting
Investigational Site Number: 3920001
Morioka 2111834, 020-8505
JapanSite Not Available
Investigational Site Number: 3920004
Nishinomiya, 663-8501
JapanActive - Recruiting
Investigational Site Number: 3920004
Nishinomiya 1855207, 663-8501
JapanSite Not Available
Investigational Site Number: 4980001
Chisinau, 2025
MoldovaActive - Recruiting
Investigational Site Number: 4980001
Chisinau 618426, 2025
MoldovaSite Not Available
Investigational Site Number: 6160006
Wroclaw, Lower Silesian Voivodeship 53-149
PolandActive - Recruiting
Investigational Site Number: 6160006
Wroclaw 3081368, Lower Silesian Voivodeship 3337492 53-149
PolandActive - Recruiting
Vistamed & Vertigo Sp. z o.o. - Site Number: 6160006
Wroclaw 3081368, Lower Silesian Voivodeship 3337492 53-149
PolandActive - Recruiting
Investigational Site Number: 6160002
Bydgoszcz, 85-229
PolandActive - Recruiting
Investigational Site Number: 6160002
Bydgoszcz 3102014, 85-229
PolandSite Not Available
Investigational Site Number: 6160009
Chojnice, 89-600
PolandActive - Recruiting
Investigational Site Number: 6160009
Chojnice 3101672, 89-600
PolandSite Not Available
Investigational Site Number: 6160007
Katowice, 40-748
PolandActive - Recruiting
Investigational Site Number: 6160007
Katowice 3096472, 40-748
PolandSite Not Available
Investigational Site Number: 6160005
Sopot, 81-756
PolandActive - Recruiting
Investigational Site Number: 6160005
Sopot 3085151, 81-756
PolandSite Not Available
Investigational Site Number: 6160008
Tychy, 43-100
PolandActive - Recruiting
Investigative Site: 6160008
Tychy 3082914, 43-100
PolandSite Not Available
Investigational Site Number: 6160003
Warsaw, 04-501
PolandActive - Recruiting
Investigational Site Number: 6160004
Warsaw, 00-189
PolandActive - Recruiting
Investigational Site Number: 6160003
Warsaw 756135, 04-501
PolandActive - Recruiting
Investigational Site Number: 6160004
Warsaw 756135, 00-189
PolandSite Not Available
Investigational Site Number: 6160001
Wroclaw, 52-210
PolandActive - Recruiting
Investigational Site Number: 6160001
Wroclaw 3081368, 52-210
PolandSite Not Available
Investigational Site Number: 7240001
Las Palmas de Gran Canaria, 35010
SpainActive - Recruiting
Investigational Site Number: 7240001
Las Palmas de Gran Canaria 2515270, 35010
SpainSite Not Available
Investigational Site Number: 7240002
Madrid, 28046
SpainActive - Recruiting
Investigational Site Number: 7240002
Madrid 3117735, 28046
SpainSite Not Available
Investigational Site Number: 8260002
Northwich, CHW CW9 7LS
United KingdomActive - Recruiting
Elpida Sciences Clinical Trials - Site Number: 8260002
Northwich 2641224, CHW CW9 7LS
United KingdomActive - Recruiting
Investigational Site Number: 8260002
Northwich 2641224, CHW CW9 7LS
United KingdomSite Not Available
Investigational Site Number: 8260003
Bury, BL9 7TD
United KingdomActive - Recruiting
Investigational Site Number: 8260003
Bury 2654187, BL9 7TD
United KingdomSite Not Available
Investigational Site Number: 8260001
London, E11 1NR
United KingdomActive - Recruiting
Investigational Site Number: 8260004
London, SE1 7EH
United KingdomActive - Recruiting
Investigational Site Number: 8260001
London 2643743, E11 1NR
United KingdomActive - Recruiting
Investigational Site Number: 8260004
London 2643743, SE1 7EH
United KingdomSite Not Available
Investigational Site Number: 8400009
Escondido, California 92025
United StatesActive - Recruiting
Gastro Care Institute - Site Number: 8400006
Lancaster, California 93534
United StatesSite Not Available
Investigational Site Number: 8400006
Lancaster, California 93534
United StatesActive - Recruiting
Investigational Site Number: 8400025
Thousand Oaks, California 91360
United StatesActive - Recruiting
Gastroenterology & Liver Institute - Site Number: 8400009
Escondido 5346827, California 5332921 92025
United StatesActive - Recruiting
Investigational Site Number: 8400009
Escondido 5346827, California 5332921 92025
United StatesSite Not Available
Gastro Care Institute - Site Number: 8400006
Lancaster 5364940, California 5332921 93534
United StatesActive - Recruiting
Investigational Site Number: 8400006
Lancaster 5364940, California 5332921 93534
United StatesSite Not Available
Clinical Trials Management Services, LLC
Thousand Oaks 5402405, California 5332921 91360
United StatesActive - Recruiting
Investigational Site Number: 8400025
Thousand Oaks 5402405, California 5332921 91360
United StatesSite Not Available
Green Leaf Clinical Trials - Site Number: 8400024
Jacksonville, Florida 32258
United StatesSite Not Available
Investigational Site Number: 8400024
Jacksonville, Florida 32258
United StatesActive - Recruiting
Investigational Site Number: 8400030
Kissimmee, Florida 347441
United StatesActive - Recruiting
Investigational Site Number: 8400003
Lighthouse PT, Florida 33064
United StatesActive - Recruiting
Alliance Medical Research LLC - Site Number: 8400003
Lighthouse Point, Florida 33064
United StatesSite Not Available
Investigational Site Number: 8400001
Miami, Florida 33134
United StatesActive - Recruiting
Investigational Site Number: 8400011
Miami, Florida 33136
United StatesActive - Recruiting
Research Associates of South Florida, LLC - Site Number: 8400001
Miami, Florida 33134
United StatesSite Not Available
Investigational Site Number: 8400010
Palmetto Bay, Florida 33176
United StatesActive - Recruiting
Tropical Clinical Trials - Site Number: 8400010
Palmetto Bay, Florida 33176
United StatesSite Not Available
Investigational Site Number: 8400019
Tampa, Florida 33609
United StatesActive - Recruiting
Green Leaf Clinical Trials - Site Number: 8400024
Jacksonville 4160021, Florida 4155751 32258
United StatesActive - Recruiting
Investigational Site Number: 8400024
Jacksonville 4160021, Florida 4155751 32258
United StatesSite Not Available
Investigational Site Number: 8400030
Kissimmee 4160983, Florida 4155751 347441
United StatesSite Not Available
Alliance Medical Research LLC - Site Number: 8400003
Lighthouse PT 4161957, Florida 4155751 33064
United StatesActive - Recruiting
Investigational Site Number: 8400003
Lighthouse PT 4161957, Florida 4155751 33064
United StatesSite Not Available
Investigational Site Number: 8400001
Miami 4164138, Florida 4155751 33134
United StatesSite Not Available
Investigational Site Number: 8400011
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
Research Associates of South Florida, LLC - Site Number: 8400001
Miami 4164138, Florida 4155751 33134
United StatesActive - Recruiting
Sylvester Comprehensive Cancer Center - Site Number: 8400011
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
Investigational Site Number: 8400010
Palmetto Bay 4167634, Florida 4155751 33176
United StatesSite Not Available
Tropical Clinical Trials - Site Number: 8400010
Palmetto Bay 4167634, Florida 4155751 33176
United StatesActive - Recruiting
Investigational Site Number: 8400019
Tampa 4174757, Florida 4155751 33609
United StatesSite Not Available
Gastrointestinal Specialists of Georgia, PC - Site Number: 8400018
Marietta, Georgia 30060
United StatesSite Not Available
Investigational Site Number: 8400018
Marietta, Georgia 30060
United StatesActive - Recruiting
Gastrointestinal Specialists of Georgia, PC - Site Number: 8400018
Marietta 4207783, Georgia 4197000 30060
United StatesActive - Recruiting
Investigational Site Number: 8400018
Marietta 4207783, Georgia 4197000 30060
United StatesSite Not Available
Investigational Site Number: 8400005
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics - Site Number: 8400005
Iowa City, Iowa 52242
United StatesSite Not Available
Investigational Site Number: 8400005
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
University of Iowa Hospitals and Clinics - Site Number: 8400005
Iowa City 4862034, Iowa 4862182 52242
United StatesActive - Recruiting
Investigational Site Number: 8400017
Boston, Massachusetts 02115
United StatesActive - Recruiting
Investigational Site: 8400017
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Gastroenterology Associates of Western Michigan - Site Number: 8400012
Wyoming, Michigan 49519
United StatesSite Not Available
Investigational Site Number: 8400012
Wyoming, Michigan 49519
United StatesActive - Recruiting
Gastroenterology Associates of Western Michigan - Site Number: 8400012
Wyoming 5015618, Michigan 5001836 49519
United StatesActive - Recruiting
Investigational Site Number: 8400012
Wyoming 5015618, Michigan 5001836 49519
United StatesSite Not Available
Investigational Site Number: 8400014
St Louis, Missouri 63110
United StatesActive - Recruiting
Investigational Site Number: 8400014
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Washington University School of Medicine - Site Number: 8400014
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Investigational Site Number: 8400021
New York, New York 10029
United StatesActive - Recruiting
Investigational Site Number: 8400029
Queens Village, New York 11428
United StatesActive - Recruiting
Investigational Site Number: 8400021
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Investigational Site Number: 8400029
Queens Village 5133271, New York 5128638 11428
United StatesSite Not Available
Investigational Site Number: 8400002
Chapel Hill, North Carolina 27514
United StatesActive - Recruiting
Investigational Site Number: 8400002
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
University of North Carolina Medical Center - Site Number: 8400002
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesActive - Recruiting
Investigational Site Number: 8400013
Harrisburg, Pennsylvania 17110
United StatesActive - Recruiting
Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400013
Harrisburg, Pennsylvania 17110
United StatesSite Not Available
Investigational Site Number: 8400013
Harrisburg 5192726, Pennsylvania 6254927 17110
United StatesSite Not Available
Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400013
Harrisburg 5192726, Pennsylvania 6254927 17110
United StatesActive - Recruiting
Investigational Site Number: 8400023
Houston, Texas 77030
United StatesActive - Recruiting
Investigational Site Number: 8400023
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Investigational Site Number: 8400007
Ogden, Utah 84405
United StatesActive - Recruiting
Advanced Research Institute - Site Number: 8400007
Ogden 5779206, Utah 5549030 84405
United StatesActive - Recruiting
Investigational Site Number: 8400007
Ogden 5779206, Utah 5549030 84405
United StatesSite Not Available

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