Phase
Condition
Ulcerative Colitis
Bowel Dysfunction
Inflammatory Bowel Disease
Treatment
SAR442970
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening
Confirmed diagnosis of moderate-to-severe CD
History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs),steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics orsmall molecules), but having inadequate response to, loss or response to orintolerance to at least one of these therapies
On stable doses of standard treatments prior to screening (Oral 5-ASA compounds,Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.)
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 with active Ulcerative Colitis (UC), indeterminate colitis, adenomatouscolonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia)or short bowel syndrome
Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region,without colonic or ileal involvement
Participants with following ongoing known complications of CD:
Any manifestation that might require bowel surgery while enrolled in the study
Participant with ostomy or ileoanal pouch
Participant diagnosed with conditions that could interfere with drug absorptionincluding but not limited to short bowel syndrome
Participant with surgical bowel resection within the past three months prior toscreening, or a history of >3 bowel resections
History of any other condition which, in the opinion of the Investigator, would putthe participant at risk by participation in the study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
Connect with a study center
Investigational Site Number: 0360002
Brisbane, Queensland 4101
AustraliaActive - Recruiting
Investigational Site Number: 0360002
Brisbane 2174003, Queensland 2152274 4101
AustraliaSite Not Available
Mater Misericordiae Limited - Site Number: 0360002
Brisbane 2174003, Queensland 2152274 4101
AustraliaActive - Recruiting
Investigational Site Number: 0360004
Kurralta Park, South Australia 5037
AustraliaActive - Recruiting
Investigational Site Number: 0360004
Kurralta Park 8348005, South Australia 2061327 5037
AustraliaSite Not Available
SA Group of Specialists - IBDSA - Site Number: 0360004
Kurralta Park 8348005, South Australia 2061327 5037
AustraliaActive - Recruiting
Investigational Site Number: 0360001
Footscray, 3011
AustraliaActive - Recruiting
Investigational Site Number: 0360001
Footscray 2166370, 3011
AustraliaSite Not Available
Investigational Site Number: 0560001
Leuven, B-3000
BelgiumActive - Recruiting
Investigational Site Number: 0560001
Leuven 2792482, B-3000
BelgiumSite Not Available
Investigational Site Number: 1560008
Changsha, 410013
ChinaActive - Recruiting
Investigative Site: 1560003
Changsha, 410011
ChinaActive - Recruiting
Investigative Site: 1560003
Changsha 1815577, 410011
ChinaSite Not Available
Investigative Site: 1560005
Changzhou, 213003
ChinaActive - Recruiting
Investigative Site: 1560005
Changzhou 1815456, 213003
ChinaSite Not Available
Investigational Site Number: 1560001
Guangzhou, 510655
ChinaActive - Recruiting
Investigational Site Number: 1560001
Guangzhou 1809858, 510655
ChinaSite Not Available
Investigational Site Number: 1560006
Hangzhou, 310009
ChinaActive - Recruiting
Investigational Site Number: 1560006
Hangzhou 1808926, 310009
ChinaSite Not Available
Investigative Site: 1560004
Nanchang, 330006
ChinaActive - Recruiting
Investigative Site: 1560004
Nanchang 1800163, 330006
ChinaSite Not Available
Investigative Site: 1560002
Shanghai, 200092
ChinaActive - Recruiting
Investigative Site: 1560002
Shanghai 1796236, 200092
ChinaSite Not Available
Investigational Site Number: 1560007
Shenyang, 110004
ChinaActive - Recruiting
Investigational Site Number: 2030002
Brno, JM 61500
CzechiaActive - Recruiting
Investigational Site Number: 2030002
Brno 3078610, JM 61500
CzechiaSite Not Available
Vojenska Nemocnice Brno - Site Number: 2030002
Brno 3078610, JM 61500
CzechiaActive - Recruiting
Investigational Site Number: 2030003
Hradec Králové, 50012
CzechiaActive - Recruiting
Hepato-Gastroenterologie HK, s.r.o. - Site Number: 2030003
Hradec Králové 3074967, 50012
CzechiaActive - Recruiting
Investigational Site Number: 2030003
Hradec Králové 3074967, 50012
CzechiaSite Not Available
Investigational Site Number: 2030005
Slaný, 274 01
CzechiaActive - Recruiting
Investigational Site Number: 2500001
Montpellier, 34090
FranceActive - Recruiting
Investigational Site Number: 2500001
Montpellier 2992166, 34090
FranceSite Not Available
Investigational Site Number: 2500003
Nice, 6000
FranceActive - Recruiting
Investigative Site: 2500003
Nice, 6000
FranceActive - Recruiting
Investigative Site: 2500003
Nice 2990440, 6000
FranceSite Not Available
Investigational Site Number: 2500002
Toulouse, 31059
FranceActive - Recruiting
Investigational Site Number: 2500002
Toulouse 2972315, 31059
FranceSite Not Available
Investigational Site Number: 2760002
Minden, Northwest 32423
GermanyActive - Recruiting
Gastroenterologische Gemeinschaftspraxis Minden - Site Number: 2760002
Minden 2871039, Northwest 32423
GermanyActive - Recruiting
Investigational Site Number: 2760002
Minden 2871039, Northwest 32423
GermanySite Not Available
Investigational Site Number: 2760003
Jena, 07747
GermanyActive - Recruiting
Investigational Site Number: 2760004
Kiel, 24105
GermanyActive - Recruiting
Investigational Site Number: 2760004
Kiel 2891122, 24105
GermanySite Not Available
Universitatsklinikum Schleswig-Holstein - Site Number: 2760004
Kiel 2891122, 24105
GermanyActive - Recruiting
Investigational Site Number: 2760001
Ulm, 89081
GermanyActive - Recruiting
Investigational Site Number: 3920007
Kashiwa, Chiba 277-0871
JapanActive - Recruiting
Investigational Site Number: 3920007
Kashiwa 1859924, Chiba 2113014 277-0871
JapanSite Not Available
Tsujinaka Hospital-Kashiwanoha - Site Number: 3920007
Kashiwa 1859924, Chiba 2113014 277-0871
JapanActive - Recruiting
Investigational Site Number: 3920005
Ōita, Oita Prefecture 870-0033
JapanActive - Recruiting
Investigational Site Number: 3920005
Ōita 1854487, Oita Prefecture 1854484 870-0033
JapanSite Not Available
Oita Red Cross Hospital - Site Number: 3920005
Ōita 1854487, Oita Prefecture 1854484 870-0033
JapanActive - Recruiting
Investigational Site Number: 3920006
Hamamatsu, Shizuoka 432-8061
JapanActive - Recruiting
Investigational Site Number: 3920006
Hamamatsu 1863289, Shizuoka 1851715 432-8061
JapanActive - Recruiting
Matsuda Hospital - Site Number: 3920006
Hamamatsu 1863289, Shizuoka 1851715 432-8061
JapanActive - Recruiting
Investigational Site Number: 3920004
Bunkyō City, 113-8519
JapanActive - Recruiting
Investigational Site Number: 3920004
Bunkyō City 11790632, 113-8519
JapanSite Not Available
Investigational Site Number: 3920003
Hamamatsu, 431-3192
JapanActive - Recruiting
Investigational Site Number: 3920003
Hamamatsu 1863289, 431-3192
JapanSite Not Available
Investigational Site Number: 3920009
Hirosaki, 036-8545
JapanActive - Recruiting
Investigational Site Number: 3920009
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: 3920002
Nishinomiya, 663-8501
JapanActive - Recruiting
Investigational Site Number: 3920002
Nishinomiya 1855207, 663-8501
JapanSite Not Available
Investigational Site Number: 6160002
Wroclaw, Lower Silesian Voivodeship 53-149
PolandActive - Recruiting
Investigational Site Number: 6160002
Wroclaw 3081368, Lower Silesian Voivodeship 3337492 53-149
PolandActive - Recruiting
Vistamed & Vertigo Sp. z o.o. - Site Number: 6160002
Wroclaw 3081368, Lower Silesian Voivodeship 3337492 53-149
PolandActive - Recruiting
Investigational Site Number: 6160001
Krakow, 31-501
PolandActive - Recruiting
Investigational Site Number: 6160001
Krakow 3094802, 31-501
PolandSite Not Available
Investigational Site Number: 6160005
Lublin, 20-582
PolandActive - Recruiting
Investigational Site Number: 6160005
Lublin 765876, 20-582
PolandSite Not Available
Investigational Site Number: 6160006
Sopot, 81-756
PolandActive - Recruiting
Investigational Site Number: 6160006
Sopot 3085151, 81-756
PolandSite Not Available
Investigational Site Number: 6160003
Warsaw, 01-783
PolandActive - Recruiting
Investigational Site Number: 6160008
Warsaw, 00-189
PolandActive - Recruiting
Investigational Site Number: 6160003
Warsaw 756135, 01-783
PolandActive - Recruiting
Investigational Site Number: 6160008
Warsaw 756135, 00-189
PolandSite Not Available
Investigational Site Number: 6160004
Wroclaw, 54-206
PolandActive - Recruiting
Investigational Site Number: 6160004
Wroclaw 3081368, 54-206
PolandSite Not Available
Investigational Site Number: 7100003
Johannesburg, 1619
South AfricaActive - Recruiting
Investigational Site Number: 7240001
Madrid, 28046
SpainActive - Recruiting
Investigational Site Number: 7240002
Madrid, 28003
SpainActive - Recruiting
Investigative Site: 7240001
Madrid, 28046
SpainActive - Recruiting
FutureMeds - Madrid Santa Elena - Site Number: 7240002
Madrid 3117735, 28003
SpainActive - Recruiting
Investigational Site Number: 7240002
Madrid 3117735, 28003
SpainActive - Recruiting
Investigative Site: 7240001
Madrid 3117735, 28046
SpainSite Not Available
Investigational Site Number: 7240003
Seville, 41009
SpainActive - Recruiting
Investigational Site Number: 7240003
Seville 2510911, 41009
SpainSite Not Available
Investigational Site Number: 8260007
Bury, BL9 7TD
United KingdomActive - Recruiting
Investigational Site Number: 8260007
Bury 2654187, BL9 7TD
United KingdomSite Not Available
Investigational Site Number: 8260004
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Investigational Site Number: 8260004
Cambridge 2653941, CB2 0QQ
United KingdomSite Not Available
Investigational Site Number: 8260001
London, SE1 7EH
United KingdomActive - Recruiting
Investigational Site Number: 8260002
London, HA8 0AD
United KingdomActive - Recruiting
Investigational Site Number: 8260005
London, E11 1NR
United KingdomActive - Recruiting
Elpida Sciences Clinical Trials - Site Number: 8260002
London 2643743, HA8 0AD
United KingdomActive - Recruiting
Investigational Site Number: 8260001
London 2643743, SE1 7EH
United KingdomActive - Recruiting
Investigational Site Number: 8260002
London 2643743, HA8 0AD
United KingdomActive - Recruiting
Investigational Site Number: 8260005
London 2643743, E11 1NR
United KingdomSite Not Available
Investigational Site Number: 84000024
Tucson, Arizona 85724
United StatesActive - Recruiting
Investigational Site Number: 8400024
Tucson, Arizona 85724
United StatesActive - Recruiting
Investigational Site Number: 8400005
Escondido, California 92025
United StatesActive - Recruiting
Gastro Care Institute - Site Number: 8400001
Lancaster, California 93534
United StatesSite Not Available
Investigational Site Number: 8400001
Lancaster, California 93534
United StatesActive - Recruiting
Gastroenterology & Liver Institute - Site Number: 8400005
Escondido 5346827, California 5332921 92025
United StatesActive - Recruiting
Investigational Site Number: 8400005
Escondido 5346827, California 5332921 92025
United StatesSite Not Available
Gastro Care Institute - Site Number: 8400001
Lancaster 5364940, California 5332921 93534
United StatesActive - Recruiting
Investigational Site Number: 8400001
Lancaster 5364940, California 5332921 93534
United StatesSite Not Available
Central Florida Gastro Research - Site Number: 8400017
Kissimmee, Florida 34741
United StatesSite Not Available
Investigational Site Number: 8400017
Kissimmee, Florida 34741
United StatesActive - Recruiting
Investigational Site Number: 8400015
Lighthouse PT, Florida 33064
United StatesActive - Recruiting
Alliance Medical Research LLC - Site Number: 8400015
Lighthouse Point, Florida 33064
United StatesSite Not Available
Investigational Site Number 84000028
Miami, Florida 33134
United StatesActive - Recruiting
Investigational Site Number 8400028
Miami, Florida 33134
United StatesActive - Recruiting
Investigational Site Number: 8400012
Miami, Florida 33136
United StatesActive - Recruiting
Investigational Site Number: 8400007
Orlando, Florida 32804
United StatesActive - Recruiting
Investigational Site Number: 8400011
Palmetto Bay, Florida 33176
United StatesActive - Recruiting
Tropical Clinical Trials - Site Number: 8400011
Palmetto Bay, Florida 33176
United StatesSite Not Available
Central Florida Gastro Research - Site Number: 8400017
Kissimmee 4160983, Florida 4155751 34741
United StatesActive - Recruiting
Investigational Site Number: 8400017
Kissimmee 4160983, Florida 4155751 34741
United StatesSite Not Available
Alliance Medical Research LLC - Site Number: 8400015
Lighthouse PT 4161957, Florida 4155751 33064
United StatesActive - Recruiting
Investigational Site Number: 8400015
Lighthouse PT 4161957, Florida 4155751 33064
United StatesSite Not Available
Investigational Site Number: 8400012
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Investigational Site Number: 8400011
Palmetto Bay 4167634, Florida 4155751 33176
United StatesSite Not Available
Tropical Clinical Trials - Site Number: 8400011
Palmetto Bay 4167634, Florida 4155751 33176
United StatesActive - Recruiting
Gastrointestinal Specialists of Georgia, PC - Site Number: 8400019
Marietta, Georgia 30060
United StatesSite Not Available
Investigational Site Number: 8400019
Marietta, Georgia 30060
United StatesActive - Recruiting
Gastrointestinal Specialists of Georgia, PC - Site Number: 8400019
Marietta 4207783, Georgia 4197000 30060
United StatesActive - Recruiting
Investigational Site Number: 8400019
Marietta 4207783, Georgia 4197000 30060
United StatesSite Not Available
Investigational Site Number: 8400025
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics - Site Number: 8400025
Iowa City, Iowa 52242
United StatesSite Not Available
Investigational Site Number: 8400025
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
University of Iowa Hospitals and Clinics - Site Number: 8400025
Iowa City 4862034, Iowa 4862182 52242
United StatesActive - Recruiting
Investigational Site Number: 8400006
Kansas City, Kansas 66160
United StatesActive - Recruiting
Investigational Site Number: 8400022
Boston, Massachusetts 02115
United StatesActive - Recruiting
Brigham and Women's Hospital - Site Number: 8400022
Boston 4930956, Massachusetts 6254926 02115
United StatesActive - Recruiting
Investigational Site Number: 8400022
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Gastroenterology Associates of Western Michigan - Site Number: 8400008
Wyoming, Michigan 49519
United StatesSite Not Available
Investigational Site Number: 8400008
Wyoming, Michigan 49519
United StatesActive - Recruiting
Gastroenterology Associates of Western Michigan - Site Number: 8400008
Wyoming 5015618, Michigan 5001836 49519
United StatesActive - Recruiting
Investigational Site Number: 8400008
Wyoming 5015618, Michigan 5001836 49519
United StatesSite Not Available
Investigational Site Number: 8400013
St Louis, Missouri 63110
United StatesActive - Recruiting
Investigational Site Number: 8400013
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Investigational Site Number: 8400003
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
Investigational Site Number: 8400002
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
University of North Carolina (UNC) - Site Number: 8400002
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesActive - Recruiting
Investigational Site Number: 8400009
Harrisburg, Pennsylvania 17110
United StatesActive - Recruiting
Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400009
Harrisburg, Pennsylvania 17110
United StatesSite Not Available
Investigational Site Number: 8400009
Harrisburg 5192726, Pennsylvania 6254927 17110
United StatesSite Not Available
Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400009
Harrisburg 5192726, Pennsylvania 6254927 17110
United StatesActive - Recruiting
Gastroenterology Research of America, LLC. - Site Number: 8400002
Fredericksburg, Texas 78229
United StatesSite Not Available
Investigational Site Number: 8400002
Fredericksburg, Texas 78229
United StatesActive - Recruiting
Gastroenterology Research of America, LLC. - Site Number: 8400002
Fredericksburg 4692279, Texas 4736286 78229
United StatesActive - Recruiting
Investigational Site Number: 8400002
Fredericksburg 4692279, Texas 4736286 78229
United StatesSite Not Available
Investigational Site Number: 8400016
Ogden, Utah 84405
United StatesActive - Recruiting
Advanced Research Institute - Site Number: 8400016
Ogden 5779206, Utah 5549030 84405
United StatesActive - Recruiting
Investigational Site Number: 8400016
Ogden 5779206, Utah 5549030 84405
United StatesSite Not Available
Investigational Site Number: 8400027
Richmond, Virginia 23249
United StatesActive - Recruiting
Investigational Site Number: 8400027
Richmond 4781708, Virginia 6254928 23249
United StatesSite Not Available
Richmond VA Medical Center - Site Number: 8400027
Richmond 4781708, Virginia 6254928 23249
United StatesActive - Recruiting

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