Phase
Condition
Bowel Dysfunction
Ulcerative Colitis
Inflammatory Bowel Disease
Treatment
SAR441566
SAR441566 matching Placebo
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 at the time of signing the ICF
Confirmed diagnosis of CD for at least 3 months prior to Baseline
Confirmed diagnosis of moderate to severe CD as assessed by:
Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score forCrohn's disease (SES-CD) on an endoscopy confirmed by a central reader
stool frequency (SF), abdominal pain (AP) score
History of prior exposure to standard treatment (5-ASA, steroids, immunomodulatorsor antibiotics) or advanced therapies (biologics or small molecules), but havinginadequate response to, loss or response to or intolerance to at least one of thesetherapies
On stable doses of standard treatments prior to screening (Oral 5-ASA compounds,Oral corticosteroids, AZA, 6-MP, or MTX ..)
Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.Women participants should not be pregnant or breastfeeding.
Exclusion
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Participants with active UC, indeterminate colitis or short bowel syndrome
Participants with CD isolated to the stomach, duodenum, jejunum, or peri analregion, without colonic or ileal involvement
Participants with following ongoing known complications of CD: fistula, abscess,symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowelresection within 3 months of screening or history of > 3 bowel resections
Participants with stool sample positive for infectious pathogens
Participants with active tuberculosis (TB) or a history of incompletely treatedactive or latent TB per local guidelines
Participants with Positive Hepatitis B surface antigen (HBsAg) or positive HepatitisB core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the ScreeningVisit
Participants with any other active, chronic or recurrent infection, includingrecurrent or disseminated herpes zoster or disseminated herpes simplex
Participants with a known history of Human Immunodeficiency Virus (HIV) infection orpositive HIV-1 or HIV-2 serology at screening
Participants presenting with active malignancies, lymphoproliferative disease, orrecurrence of either, within the 5 years before screening
Participants with adenomatous colonic polyps or colonic mucosal dysplasia (low- orhigh grade) not excised or incompletely excised
Infection(s) requiring treatment with IV anti infectives within 30 days ororal/intramuscular anti-infectives within 14 days prior to the screening visit
Participants requiring or receiving any parental nutrition and/or exclusive enteralnutrition
Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, orthalidomide within 30 days prior to screening
Participants who received fecal microbial transplantation within 30 days prior toscreening
Participants who have ever been exposed to natalizumab (Tysabri®) or oralcarotegrast methyl (Carogra®)
Participants who received IV corticosteroids within 14 days prior to screening orduring screening period
Participants who received therapeutic enema or suppository, other than required forcolonoscopy within 14 days prior to screening or during screening
Screening laboratory and other analyses show abnormal results
Study Design
Connect with a study center
Investigational Site Number : 0320002
San Miguel de Tucumán, Tucumán 4000
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
Buenos Aires, 1125
ArgentinaActive - Recruiting
Investigational Site Number : 0320003
Buenos Aires, 1061
ArgentinaActive - Recruiting
Investigational Site Number : 0320005
Buenos Aires, 1128
ArgentinaActive - Recruiting
Investigational Site Number : 0360002
Sydney, New South Wales 2139
AustraliaActive - Recruiting
Investigational Site Number : 0360001
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Investigational Site Number : 0360003
Parkville, Victoria 3050
AustraliaActive - Recruiting
Hospital Moinhos de Vento- Site Number : 0760006
Porto Alegre, Rio Grande Do Sul 90035-902
BrazilActive - Recruiting
Investigational Site Number : 1000001
Gorna Oryahovitsa, 5100
BulgariaActive - Recruiting
Investigational Site Number : 1240001
Calgary, Alberta T2N 4Z6
CanadaActive - Recruiting
Investigational Site Number : 1240003
Montreal, Quebec H3H 1E3
CanadaActive - Recruiting
Investigational Site Number : 1240005
Québec City, Quebec G1V 4T3
CanadaActive - Recruiting
Investigational Site Number : 1520001
Santiago, Reg Metropolitana De Santiago 8331143
ChileActive - Recruiting
Investigational Site Number : 1520002
Viña Del Mar, Valparaíso 2540364
ChileActive - Recruiting
Investigational Site Number : 1560008
Changzhou, 213000
ChinaActive - Recruiting
Investigational Site Number : 1560009
Chongqing, 400013
ChinaActive - Recruiting
Investigational Site Number : 1560012
Fuzhou, 350005
ChinaActive - Recruiting
Investigational Site Number : 1560001
Guangzhou, 510080
ChinaActive - Recruiting
Investigational Site Number : 1560003
Hangzhou, 310016
ChinaActive - Recruiting
Investigational Site Number : 1560004
Hangzhou, 310009
ChinaActive - Recruiting
Investigational Site Number : 1560007
Hefei, 230022
ChinaActive - Recruiting
Investigational Site Number : 1560011
Nanchang, 330006
ChinaActive - Recruiting
Investigational Site Number : 1560010
Suzhou, 215004
ChinaActive - Recruiting
Investigational Site Number : 1910004
Osijek, 31000
CroatiaActive - Recruiting
Investigational Site Number : 2500003
Toulouse Cedex 9, 31059
FranceActive - Recruiting
Investigational Site Number : 2760002
Berlin, 12200
GermanyActive - Recruiting
Investigational Site Number : 2760004
Berlin, 10318
GermanyActive - Recruiting
Investigational Site Number : 2760005
Halle, 06108
GermanyActive - Recruiting
Investigational Site Number : 3800008
Roma, Lazio 00128
ItalyActive - Recruiting
Investigational Site Number : 3800002
Milan, Milano 20132
ItalyActive - Recruiting
Investigational Site Number : 3800004
Rozzano, Milano 20089
ItalyActive - Recruiting
Investigational Site Number : 3800001
Padua, Padova 35128
ItalyActive - Recruiting
Investigational Site Number : 3800005
Pisa, 56124
ItalyActive - Recruiting
Investigational Site Number : 3920004
Kashiwa, Chiba 277-0871
JapanActive - Recruiting
Investigational Site Number : 3920001
Sakura, Chiba 285-0841
JapanActive - Recruiting
Investigational Site Number : 3920006
Sapporo, Hokkaido 004-0041
JapanActive - Recruiting
Investigational Site Number : 3920007
Sapporo, Hokkaido 065-0033
JapanActive - Recruiting
Investigational Site Number : 3920010
Sapporo, Hokkaido 064-0919
JapanActive - Recruiting
Investigational Site Number : 3920008
Morioka, Iwate 020-8505
JapanActive - Recruiting
Investigational Site Number : 3920019
Takamatsu-shi, Kagawa 760-0017
JapanActive - Recruiting
Investigational Site Number : 3920020
Nagaoka, Niigata 940-2108
JapanActive - Recruiting
Investigational Site Number : 3920002
Osaka-shi, Osaka 530-0011
JapanActive - Recruiting
Investigational Site Number : 3920003
Bunkyo, Tokyo 113-8510
JapanActive - Recruiting
Investigational Site Number : 3920011
Shinjuku-ku, Tokyo 169-0073
JapanActive - Recruiting
Investigational Site Number : 3920018
Oita, 870-0033
JapanActive - Recruiting
Investigational Site Number : 3920012
Wakayama, 640-8558
JapanActive - Recruiting
Investigational Site Number : 5280004
Breda, 4818 CK
NetherlandsActive - Recruiting
Investigational Site Number : 5280002
Nijmegen, 6525 GA
NetherlandsActive - Recruiting
Investigational Site Number : 5280001
Tilburg, 5022 GC
NetherlandsActive - Recruiting
Investigational Site Number : 7240002
Seville, Sevilla 41009
SpainActive - Recruiting
Investigational Site Number : 7920001
Akdeniz, 33070
TurkeyActive - Recruiting
Investigational Site Number : 7920003
Istanbul, 34899
TurkeyActive - Recruiting
Investigational Site Number : 7920002
Zonguldak, 67000
TurkeyActive - Recruiting
Connecticut Clinical Research Institute- Site Number : 8400007
Bristol, Connecticut 06010
United StatesActive - Recruiting
Clinical Research of Osceola- Site Number : 8400013
Kissimmee, Florida 34741
United StatesActive - Recruiting
Wellness Clinical Research - Miami Lakes- Site Number : 8400010
Miami Lakes, Florida 33016
United StatesActive - Recruiting
GI Alliance - Glenview- Site Number : 8400015
Glenview, Illinois 60026
United StatesActive - Recruiting
Illinois Gastroenterology Group- Site Number : 8400011
Gurnee, Illinois 60031
United StatesActive - Recruiting
GIA Alliance - Flowood - Site Number : 8400019
Flowood, Mississippi 39232
United StatesActive - Recruiting
Vector Clinical Trials- Site Number : 8400001
Las Vegas, Nevada 89128
United StatesActive - Recruiting
A1 Clinical Network- Site Number : 8400005
New York, New York 11428
United StatesActive - Recruiting
Frontier Clinical Research - Uniontown- Site Number : 8400009
Uniontown, Pennsylvania 15401
United StatesActive - Recruiting
Frontier Clinical Research, LLC- Site Number : 8400009
Uniontown, Pennsylvania 15401
United StatesActive - Recruiting
Vitality Digestive Institute Clinical Research- Site Number : 8400003
Katy, Texas 77494
United StatesActive - Recruiting
Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
Southlake, Texas 76092
United StatesActive - Recruiting
Washington Gastroenterology - Tacoma- Site Number : 8400008
Tacoma, Washington 98405
United StatesActive - Recruiting
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