Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Placebo
SAR443122
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who have clinical evidence of active Ulcerative Colitis [UC] for ≥3months before screening as confirmed by endoscopy during the screening period.
Participants must have a minimum disease extent of 15 centimeters from the analverge.
Participants are inadequate or non-responders, have shown loss of response, or areintolerant to at least 1 of following approved treatments: amino-salicylate,corticosteroids, immunosuppressants or biologics other than natalizumab (Tysabri®)or small molecules.
Participants on corticosteroids must be on a stable dose ≥2 weeks prior to screeningand during screening period.
Participants on methotrexate, azathioprine or 6- mercaptopurine must be on treatmentfor at least 8 weeks prior to screening; and on a stable dose ≥4 weeks prior toscreening and during screening period.
Participants on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on astable dose for ≥4 weeks prior to screening and during screening period.
Participants on advanced therapies must have 1) last administration at least 5half-lives prior to randomization, or 2) undetectable level of the biologic in theirblood prior to randomization.
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 with Crohn's Disease (CD).
Participants with diagnosis of indeterminate colitis or microscopic colitis.
Participants with stool sample positive for culture for aerobic pathogens or Cdifficile.
Participants with prior colectomy or anticipated colectomy during theirparticipation in the study.
Participants with presence of ileal pouch or ostomy.
Participants with fulminant disease or toxic megacolon.
Participants with colonic dysplasia except for adenoma.
Participants with intestinal failure or short bowel syndrome requiring TotalParenteral Nutrition (TPN).
Participants with history of recurrent or recent serious infection that has notresolved within 4 weeks prior to randomization.
Participants presenting with active malignancies or recurrence of malignancy withinthe 5 years before screening.
Participants with a history or presence of another significant illness thataccording to the investigator's judgment would adversely affect the subject'sability to participate in this study.
Participants presenting with fever (≥38°C) or persistent chronic or active recurringinfection within 4 weeks prior to the Screening Visit requiring treatment withantibiotics, antivirals, or any history of frequent recurrent infections deemedunacceptable per investigator's judgment.
Participants who were administered any live (attenuated) vaccine within 3 monthsprior to the randomization Visit.
Participants with a history of recurrent herpes zoster.
Participants with uncontrolled diabetes, defined as HbA1c ≥9.0% at the ScreeningVisit.
Participants with active tuberculosis (TB) or non-tuberculous mycobacterialinfection, or a history of incompletely treated active or latent TB per localguidelines will be excluded from the study unless it is documented by a specialistthat the participant has been adequately treated and can now start treatment withthe RIPK1 kinase inhibitor.
Participants presenting with opportunistic infections within six months prior toscreening or while receiving anti-TNF treatment in the last 6 months.
Participants undergoing hemodialysis or peritoneal dialysis.
Participants with a known history of Human Immunodeficiency Virus (HIV) infection orpositive HIV serology at screening.
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 that were treated for HCV and clear the virus documented by HCVRNA by PCR below the limit of quantification can be eligible.
Positive COVID-19 test, suspected COVID-19 infection or known exposure to COVID-19during the screening period.
History of COVID-19 infection within 4 weeks prior to Screening; history ofmechanical ventilation or extracorporeal membrane oxygenation (ECMO) due to COVID-19infection within 3 months prior to Screening or with residual significantcomplications from COVID-19 making it unsafe for the participant to enter thisstudy.
Participants presenting alcohol or drug dependency within the 2 years prior to theScreening Visit.
Participants with unexplained, uncontrolled, or untreated thyroid disease orunexplained abnormal serum prolactin levels at screening.
Participants under cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus treatment within 4 weeks prior to screening.
Participants with previous exposure to natalizumab (Tysabri®).
Participants with previous exposure to RIPK1 inhibitor.
Participants under antidiarrheals within 2 weeks prior to screening and duringscreening period.
Participants under prednisone >25 mg/day (or equivalent).
Participants under budesonide >9 mg/day.
Participants who received intravenous corticosteroids or cytapheresis therapy within 2 weeks prior to screening or during screening.
Participants who were rectally administered topical 5-aminosalicylate orcorticosteroids within 4 weeks prior to screening.
Participants who received therapeutic enema or suppository, other than required forcolonoscopy or flexible sigmoidoscopy within 4 weeks prior to screening or duringscreening.
Participants who received antibiotics for UC or gastrointestinal infection within 4weeks prior to screening.
Participants who have taken other investigational medications within 2 months or 5half--lives, (whichever is longer) prior to screening.
Presence of significant laboratory findings at the Screening Visit.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Investigational Site Number : 0320002
Caba, Buenos Aires C1128AAF
ArgentinaSite Not Available
Investigational Site Number : 0320003
Rosario, Santa Fe 2002
ArgentinaActive - Recruiting
Investigational Site Number : 0320002
Buenos Aires, 1128
ArgentinaActive - Recruiting
Investigational Site Number : 0320004
Córdoba, 5000
ArgentinaActive - Recruiting
Investigational Site Number : 0320005
Córdoba, 5000
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
San Miguel de Tucuman, 4000
ArgentinaSite Not Available
Investigational Site Number :0320001
San Miguel de Tucuman, T4000AXL
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
San Miguel de Tucumán, 4000
ArgentinaActive - Recruiting
Investigational Site Number : 1520001
Santiago, Reg Metropolitana De Santiago 7500010
ChileActive - Recruiting
Investigational Site Number : 1520005
Santiago, Reg Metropolitana De Santiago 7620001
ChileActive - Recruiting
Investigational Site Number :1520001
Santiago, Reg Metropolitana De Santiago 7500010
ChileActive - Recruiting
Investigational Site Number : 1520004
Talcahuano, 2687000
ChileActive - Recruiting
Investigational Site Number : 1560001
Guangzhou, 510655
ChinaActive - Recruiting
Investigational Site Number : 1560004
Hangzhou, 310016
ChinaActive - Recruiting
Investigational Site Number : 1560003
Hefei, 230022
ChinaActive - Recruiting
Investigational Site Number : 1560006
Nanchang, 330006
ChinaActive - Recruiting
Investigational Site Number : 1560007
Nanjing, 210008
ChinaActive - Recruiting
Investigational Site Number : 1560005
Shanghai, 200025
ChinaActive - Recruiting
Investigational Site Number : 1560002
Shenyang, 110004
ChinaActive - Recruiting
Investigational Site Number : 2030001
Hradec Kralove, 50012
CzechiaSite Not Available
Investigational Site Number : 2030001
Hradec Králové, 500 12
CzechiaActive - Recruiting
Investigational Site Number : 2030002
Klatovy, 339 01
CzechiaActive - Recruiting
Investigational Site Number : 2030003
Prague, 190 00
CzechiaActive - Recruiting
Investigational Site Number : 2030004
Prague, 190 00
CzechiaActive - Recruiting
Investigational Site Number : 2030003
Praha, 19000
CzechiaSite Not Available
Investigational Site Number : 2030004
Praha, 19000
CzechiaActive - Recruiting
Investigational Site Number : 2500007
Marseille, 13915
FranceActive - Recruiting
Investigational Site Number : 2500006
Neuilly Sur Seine, 92200
FranceSite Not Available
Investigational Site Number : 2500006
Neuilly-sur-seine, 92200
FranceActive - Recruiting
Investigational Site Number : 2500001
Vandoeuvre-les-nancy, 54511
FranceSite Not Available
Investigational Site Number : 2500001
Vandœuvre-lès-nancy, 54511
FranceActive - Recruiting
Investigational Site Number : 2680003
Batumi, 6000
GeorgiaActive - Recruiting
Investigational Site Number : 2680002
Tbilisi, 0160
GeorgiaActive - Recruiting
Investigational Site Number : 2680004
Tbilisi, 0186
GeorgiaActive - Recruiting
Investigational Site Number : 2760001
Kiel, 24105
GermanyActive - Recruiting
Investigational Site Number : 2760008
Ludwigshafen, 67067
GermanyActive - Recruiting
Investigational Site Number : 2760004
Nürtingen, 72622
GermanySite Not Available
Investigational Site Number : 2760006
ULM, 89081
GermanyActive - Recruiting
Investigational Site Number : 3480002
Budapest, 1085
HungaryActive - Recruiting
Investigational Site Number : 3480003
Budapest, 1033
HungaryActive - Recruiting
Investigational Site Number : 3480005
Budapest, 1068
HungaryActive - Recruiting
Investigational Site Number : 3480001
Bã©kã©scsaba, 5600
HungarySite Not Available
Investigational Site Number : 3480001
Békéscsaba, 5600
HungaryActive - Recruiting
Investigational Site Number : 3480006
Gyã¶ngyã¶s, 3200
HungarySite Not Available
Investigational Site Number : 3480006
Gyöngyös, 3200
HungaryActive - Recruiting
Investigational Site Number : 3560003
Gurgaon, 122002
IndiaSite Not Available
Investigational Site Number : 3560003
Gurugram, 122002
IndiaActive - Recruiting
Investigational Site Number : 3560001
Jaipur, 302004
IndiaSite Not Available
Investigational Site Number : 3560005
Kochi, 682017
IndiaActive - Recruiting
Investigational Site Number : 3560004
Ludhiana, 141010
IndiaActive - Recruiting
Investigational Site Number : 3560007
Pune, 411001
IndiaActive - Recruiting
Investigational Site Number : 3560008
Rajkot, 360005
IndiaActive - Recruiting
Investigational Site Number : 3560006
Thiruvananthapuram, 695011
IndiaActive - Recruiting
Investigational Site Number : 3560001
Vivekanand MARG, JAIPUR
IndiaActive - Recruiting
Investigational Site Number : 3800005
Rozzano, Lombardia 20089
ItalyActive - Recruiting
Investigational Site Number : 3800003
Milan, Milano 20132
ItalyActive - Recruiting
Investigational Site Number : 3800002
Rome, Roma 00168
ItalyActive - Recruiting
Investigational Site Number : 3800004
Catanzaro, 88100
ItalyActive - Recruiting
Investigational Site Number : 3800003
Milano, 20132
ItalySite Not Available
Investigational Site Number : 3800006
Palermo, 90146
ItalyActive - Recruiting
Investigational Site Number : 3800001
Pavia, 27100
ItalyActive - Recruiting
Investigational Site Number : 3800002
Roma, 00168
ItalySite Not Available
Investigational Site Number : 3800007
San Donato Milanese, 20097
ItalyActive - Recruiting
Investigational Site Number : 3920004
Kitakyushu, Fukuoka 802-0803
JapanActive - Recruiting
Investigational Site Number : 3920004
Kokuraminami-ku Kitakyushu-shi, Fukuoka 802-8533
JapanSite Not Available
Investigational Site Number : 3920002
Fukushima, Hiroshima 720-0825
JapanActive - Recruiting
Investigational Site Number : 3920002
Fukuyama-shi, Hiroshima 720-8520
JapanSite Not Available
Investigational Site Number : 3920001
Oita-shi, Oita 870-0823
JapanSite Not Available
Investigational Site Number : 3920003
Osaka-shi, Osaka 540-0006
JapanSite Not Available
Investigational Site Number : 3920005
Hamamatsu, Shizuoka 432-8061
JapanActive - Recruiting
Investigational Site Number : 3920005
Hamamatsu-shi, Shizuoka 432-8061
JapanSite Not Available
Investigational Site Number : 3920001
Oita, 870-0823
JapanActive - Recruiting
Investigational Site Number : 3920003
Osaka, 540-0006
JapanActive - Recruiting
Investigational Site Number : 3920006
Saitama, 330-8553
JapanActive - Recruiting
Investigational Site Number : 4840003
Chihahua, Chihuahua 31203
MexicoSite Not Available
Investigational Site Number : 4840001
Chihuahua, 31000
MexicoActive - Recruiting
Investigational Site Number : 4840003
Chihuahua, 31203
MexicoActive - Recruiting
Investigational Site Number : 4840002
Durango, 34000
MexicoActive - Recruiting
Investigational Site Number : 5280001
Amsterdam, 1081 HV
NetherlandsActive - Recruiting
Investigational Site Number : 5280002
Nijmegen, 6525 GA
NetherlandsActive - Recruiting
Investigational Site Number : 5280004
Tilburg, 5022 GC
NetherlandsActive - Recruiting
Investigational Site Number : 6160010
Leczna, Lubuskie 21-010
PolandActive - Recruiting
Investigational Site Number : 6160005
Pulawy, Lubuskie 24-100
PolandSite Not Available
Investigational Site Number : 6160006
Krakow, Malopolskie 31-501
PolandActive - Recruiting
Investigational Site Number : 6160002
Warsaw, Mazowieckie 02-507
PolandActive - Recruiting
Investigational Site Number : 6160002
Warszawa, Mazowieckie 02-507
PolandSite Not Available
Investigational Site Number : 6160009
Katowice, 40-748
PolandActive - Recruiting
Investigational Site Number : 6160004
Wroclaw, 50-162
PolandActive - Recruiting
Investigational Site Number : 7030003
Banska Bystrica, 97401
SlovakiaSite Not Available
Investigational Site Number : 7030003
Banská Bystrica, 975 17
SlovakiaActive - Recruiting
Investigational Site Number : 7030002
Kosice, 04013
SlovakiaSite Not Available
Investigational Site Number : 7030002
Košice, 040 13
SlovakiaActive - Recruiting
Investigational Site Number : 7030001
Nitra, 949 01
SlovakiaActive - Recruiting
Investigational Site Number : 7240007
Gijón, Asturias 33394
SpainActive - Recruiting
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona] 08022
SpainActive - Recruiting
Investigational Site Number : 7240001
Madrid, Madrid, Comunidad De 28046
SpainActive - Recruiting
Investigational Site Number : 7240005
Madrid, Madrid, Comunidad De 28006
SpainSite Not Available
Investigational Site Number : 7240002
Valencia, Valenciana, Comunidad 46007
SpainSite Not Available
Investigational Site Number : 8260002
Cambridge, Cambridgeshire CB2 2QQ
United KingdomSite Not Available
Investigational Site Number : 8260006
London, London, City Of SE1 9RT
United KingdomActive - Recruiting
Investigational Site Number : 8260003
Warrington, WA5 1LZ
United KingdomActive - Recruiting
Investigational Site Number :8260003
Warrington, WA5 1QG
United KingdomActive - Recruiting
Om Research LLC- Site Number : 8400014
Lancaster, California 93534
United StatesActive - Recruiting
Om Research Site Number : 8400014
Lancaster, California 93534
United StatesActive - Recruiting
Om Research- Site Number : 8400014
Lancaster, California 93534
United StatesActive - Recruiting
United Medical Doctors Site Number : 8400005
Los Alamitos, California 90720
United StatesSite Not Available
United Medical Doctors-Site Number:8400005
Los Alamitos, California 90720
United StatesActive - Recruiting
Gastrointestinal Bioscience Site Number : 8400006
Los Angeles, California 90067
United StatesActive - Recruiting
Gastrointestinal Bioscience-Site Number:8400006
Los Angeles, California 90067
United StatesActive - Recruiting
BVL Clinical Research Site Number : 8400015
Liberty, Missouri 64068
United StatesActive - Recruiting
BVL Clinical Research- Site Number : 8400015
Liberty, Missouri 64068
United StatesActive - Recruiting
BVL Research- Site Number : 8400015
Liberty, Missouri 64068
United StatesActive - Recruiting
Las Vegas Medical Research Site Number : 8400004
Las Vegas, Nevada 89128
United StatesActive - Recruiting
Las Vegas Medical Research-Site Number:8400004
Las Vegas, Nevada 89113
United StatesActive - Recruiting
Vector Clinical Trials Site Number : 8400004
Las Vegas, Nevada 89128
United StatesActive - Recruiting
Vector Clinical Trials- Site Number : 8400004
Las Vegas, Nevada 89128
United StatesActive - Recruiting
Sanmora Bespoke Clinical Research Site Number : 8400016
East Orange, New Jersey 07018
United StatesActive - Recruiting
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400016
East Orange, New Jersey 07018
United StatesActive - Recruiting
Sanmora Bespoke Clinical Research- Site Number : 8400016
East Orange, New Jersey 07018
United StatesActive - Recruiting
NY Scientific Site Number : 8400013
Brooklyn, New York 11235
United StatesActive - Recruiting
NY Scientific- Site Number : 8400013
Brooklyn, New York 11235
United StatesActive - Recruiting
Pioneer Clinical NY Site Number : 8400017
New York, New York 10016
United StatesActive - Recruiting
Pioneer Clinical NY- Site Number : 8400017
New York, New York 10016
United StatesActive - Recruiting
Pioneer Clinical Research - New York- Site Number : 8400017
New York, New York 10016
United StatesActive - Recruiting
Onsite Clinical Solutions-Site Number:8400003
Salisbury, North Carolina 28144
United StatesSite Not Available
Gastro One Site Number : 8400002
Cordova, Tennessee 38018
United StatesSite Not Available
Gastro One- Site Number : 8400002
Cordova, Tennessee 38018
United StatesSite Not Available
Gastro One - Germantown- Site Number : 8400002
Germantown, Tennessee 38138
United StatesSite Not Available
1960 Family Practice- Site Number : 8400019
Houston, Texas 77090
United StatesActive - Recruiting
Houston Methodist Hospital- Site Number : 8400023
Houston, Texas 77030
United StatesActive - Recruiting
GI Alliance - Mansfield- Site Number : 8400010
Mansfield, Texas 76063
United StatesActive - Recruiting
GI Alliance Research Site Number : 8400010
Mansfield, Texas 76063
United StatesActive - Recruiting
GI Alliance Research- Site Number : 8400010
Mansfield, Texas 76063
United StatesActive - Recruiting
Southern Star Research Institute- Site Number : 8400011
San Antonio, Texas 78229
United StatesActive - Recruiting
Southern Star Research Site Number : 8400011
San Antonio, Texas 78229
United StatesActive - Recruiting
Southern Star Research- Site Number : 8400011
San Antonio, Texas 78229
United StatesActive - Recruiting
Integrity Research - Sugar Land- Site Number : 8400026
Sugar Land, Texas 77478
United StatesActive - Recruiting
Integrity Research- Site Number : 8400026
Sugar Land, Texas 77478
United StatesActive - Recruiting
Richmond VAMC- Site Number : 8400022
Richmond, Virginia 23249
United StatesActive - Recruiting
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