Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis
NCT ID: NCT05588843
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
182 participants
INTERVENTIONAL
2022-11-25
2026-12-16
Brief Summary
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The study consists of 4 parallel arms (3 dose groups of SAR443122 vs placebo) to assess the efficacy and safety of SAR443122 in participants with moderate to severe UC. All participants will receive a total of 52 weeks (a 12-week induction treatment phase and a 40-week maintenance phase) of study treatment, except if treatment should be discontinued per investigator's assessment.
At the end of the first 12 weeks of induction treatment, all participants in clinical response or remission will be offered study treatment up to 40 weeks and will continue with the same blinded treatment that was assigned. Participants who do not achieve clinical response or remission at the end of the initial 12 weeks induction treatment will roll over in an open-label treatment arm and will be treated with SAR443122 at the highest tested dose.
In addition, participants from the maintenance treatment that lose clinical efficacy at any time up to V10/Week 40 (Week 28 of maintenance) will be offered to roll over in the open-label treatment arm with SAR443122 at the highest dose.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR443122 level 1
Dose level 1
SAR443122
oral capsule
SAR443122 level 2
Dose level 2
SAR443122
oral capsule
SAR443122 level 3
Dose level 3
SAR443122
oral capsule
Placebo
Matching Placebo
Placebo
oral capsule
Interventions
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SAR443122
oral capsule
Placebo
oral capsule
Eligibility Criteria
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Inclusion Criteria
* Participants must have a minimum disease extent of 15 centimeters from the anal verge.
* Participants are inadequate or non-responders, have shown loss of response, or are intolerant 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 screening and during screening period.
* Participants on methotrexate, azathioprine or 6- mercaptopurine must be on treatment for at least 8 weeks prior to screening; and on a stable dose ≥4 weeks prior to screening and during screening period.
* Participants on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥4 weeks prior to screening and during screening period.
* Participants on advanced therapies must have 1) last administration at least 5 half-lives prior to randomization, or 2) undetectable level of the biologic in their blood prior to randomization.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.
Exclusion Criteria
* Participants with diagnosis of indeterminate colitis or microscopic colitis.
* Participants with stool sample positive for culture for aerobic pathogens or C difficile.
* Participants with prior colectomy or anticipated colectomy during their participation 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 Total Parenteral Nutrition (TPN).
* Participants with history of recurrent or recent serious infection that has not resolved within 4 weeks prior to randomization.
* Participants presenting with active malignancies or recurrence of malignancy within the 5 years before screening.
* Participants with a history or presence of another significant illness that according to the investigator's judgment would adversely affect the subject's ability to participate in this study.
* Participants presenting with fever (≥38°C) or persistent chronic or active recurring infection within 4 weeks prior to the Screening Visit requiring treatment with antibiotics, antivirals, or any history of frequent recurrent infections deemed unacceptable per investigator's judgment.
* Participants who were administered any live (attenuated) vaccine within 3 months prior to the randomization Visit.
* Participants with a history of recurrent herpes zoster.
* Participants with uncontrolled diabetes, defined as HbA1c ≥9.0% at the Screening Visit.
* Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated active or latent TB per local guidelines will be excluded from the study unless it is documented by a specialist that the participant has been adequately treated and can now start treatment with the RIPK1 kinase inhibitor.
* Participants presenting with opportunistic infections within six months prior to screening 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 or positive HIV serology at screening.
* Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit. Participants that were treated for HCV and clear the virus documented by HCV RNA by PCR below the limit of quantification can be eligible.
* Positive COVID-19 test, suspected COVID-19 infection or known exposure to COVID-19 during the screening period.
* History of COVID-19 infection within 4 weeks prior to Screening; history of mechanical ventilation or extracorporeal membrane oxygenation (ECMO) due to COVID-19 infection within 3 months prior to Screening or with residual significant complications from COVID-19 making it unsafe for the participant to enter this study.
* Participants presenting alcohol or drug dependency within the 2 years prior to the Screening Visit.
* Participants with unexplained, uncontrolled, or untreated thyroid disease or unexplained 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 during screening 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 or corticosteroids within 4 weeks prior to screening.
* Participants who received therapeutic enema or suppository, other than required for colonoscopy or flexible sigmoidoscopy within 4 weeks prior to screening or during screening.
* Participants who received antibiotics for UC or gastrointestinal infection within 4 weeks prior to screening.
* Participants who have taken other investigational medications within 2 months or 5 half--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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Om Research - Lancaster - 15th Street West- Site Number : 8400014
Lancaster, California, United States
Agile Clinical Research Trials- Site Number : 8400024
Atlanta, Georgia, United States
Endeavor Health - Evanston Hospital- Site Number : 8400027
Evanston, Illinois, United States
BVL Research- Site Number : 8400015
Liberty, Missouri, United States
Vector Clinical Trials- Site Number : 8400004
Las Vegas, Nevada, United States
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400016
East Orange, New Jersey, United States
NY Scientific- Site Number : 8400013
Brooklyn, New York, United States
Pioneer Clinical Research - New York- Site Number : 8400017
New York, New York, United States
Gastro One - Walnut Run Road- Site Number : 8400002
Cordova, Tennessee, United States
Houston Methodist Hospital- Site Number : 8400023
Houston, Texas, United States
1960 Family Practice- Site Number : 8400019
Houston, Texas, United States
GI Alliance - Mansfield- Site Number : 8400010
Mansfield, Texas, United States
Integrity Research - Sugar Land- Site Number : 8400026
Sugar Land, Texas, United States
Richmond VA Medical Center- Site Number : 8400022
Richmond, Virginia, United States
Investigational Site Number : 0320003
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320001
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320006
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Córdoba, , Argentina
Investigational Site Number : 0320005
Córdoba, , Argentina
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520007
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1520004
Talcahuano, Región del Biobío, Chile
Investigational Site Number : 1560001
Guangzhou, , China
Investigational Site Number : 1560004
Hangzhou, , China
Investigational Site Number : 1560003
Hefei, , China
Investigational Site Number : 1560006
Nanchang, , China
Investigational Site Number : 1560007
Nanjing, , China
Investigational Site Number : 1560005
Shanghai, , China
Investigational Site Number : 1560002
Shenyang, , China
Investigational Site Number : 2030007
České Budějovice, , Czechia
Investigational Site Number : 2030001
Hradec Králové, , Czechia
Investigational Site Number : 2030002
Klatovy, , Czechia
Investigational Site Number : 2030003
Prague, , Czechia
Investigational Site Number : 2500007
Marseille, , France
Investigational Site Number : 2500008
Nantes, , France
Investigational Site Number : 2500006
Neuilly-sur-Seine, , France
Investigational Site Number : 2500001
Vandœuvre-lès-Nancy, , France
Investigational Site Number : 2680003
Batumi, , Georgia
Investigational Site Number : 2680005
Kutaisi, , Georgia
Investigational Site Number : 2680002
Tbilisi, , Georgia
Investigational Site Number : 2680004
Tbilisi, , Georgia
Investigational Site Number : 6420001
Düsseldorf, , Germany
Investigational Site Number : 2760003
Fulda, , Germany
Investigational Site Number : 2760001
Kiel, , Germany
Investigational Site Number : 2760008
Ludwigshafen, , Germany
Investigational Site Number : 2760006
Ulm, , Germany
Investigational Site Number : 3480001
Békéscsaba, , Hungary
Investigational Site Number : 3480005
Budapest, , Hungary
Investigational Site Number : 3480002
Budapest, , Hungary
Investigational Site Number : 3480006
Gyöngyös, , Hungary
Investigational Site Number : 3560003
Gurgaon, , India
Investigational Site Number : 3560009
Jaipur, , India
Investigational Site Number : 3560001
Jaipur, , India
Investigational Site Number : 3560005
Kochi, , India
Investigational Site Number : 3560004
Ludhiana, , India
Investigational Site Number : 3560013
New Delhi, , India
Investigational Site Number : 3560007
Pune, , India
Investigational Site Number : 3560008
Rajkot, , India
Investigational Site Number : 3560012
Secunderabad, , India
Investigational Site Number : 3560010
Surat, , India
Investigational Site Number : 3560011
Surat, , India
Investigational Site Number : 3560006
Thiruvananthapuram, , India
Investigational Site Number : 3800008
Bolzano, Bolzano / Bozen, Italy
Investigational Site Number : 3800007
Milan, Milano, Italy
Investigational Site Number : 3800003
Milan, Milano, Italy
Investigational Site Number : 3800005
Rozzano, Milano, Italy
Investigational Site Number : 3800002
Rome, Roma, Italy
Investigational Site Number : 3800004
Catanzaro, , Italy
Investigational Site Number : 3800006
Palermo, , Italy
Investigational Site Number : 3800001
Pavia, , Italy
Investigational Site Number : 3920011
Nagaoka, Niigata, Japan
Investigational Site Number : 3920005
Hamamatsu, Shizuoka, Japan
Investigational Site Number : 3920007
Chūō, Tokyo, Japan
Investigational Site Number : 3920002
Fukushima, , Japan
Investigational Site Number : 3920003
Osaka, , Japan
Investigational Site Number : 3920001
Ōita, , Japan
Investigational Site Number : 3920006
Saitama, , Japan
Investigational Site Number : 4840005
Mérida, Yucatán, Mexico
Investigational Site Number : 4840001
Chihuahua City, , Mexico
Investigational Site Number : 4840003
Chihuahua City, , Mexico
Investigational Site Number : 4840002
Durango, , Mexico
Investigational Site Number : 4840006
Tlalnepantla, , Mexico
Investigational Site Number : 5280001
Amsterdam, , Netherlands
Investigational Site Number : 5280002
Nijmegen, , Netherlands
Investigational Site Number : 6160018
Włocławek, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160004
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160010
Łęczna, Lublin Voivodeship, Poland
Investigational Site Number : 6160002
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160017
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160006
Gdynia, Pomeranian Voivodeship, Poland
Investigational Site Number : 6160009
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160011
Tychy, Silesian Voivodeship, Poland
Investigational Site Number : 6160016
Katowice, , Poland
Investigational Site Number : 6160015
Krakow, , Poland
Investigational Site Number : 6420002
Cluj-Napoca, , Romania
Investigational Site Number : 7030003
Banská Bystrica, , Slovakia
Investigational Site Number : 7030002
Košice, , Slovakia
Investigational Site Number : 7030001
Nitra, , Slovakia
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240007
Gijón, Principality of Asturias, Spain
Investigational Site Number : 8260002
Cambridge, Cambridgeshire, United Kingdom
Investigational Site Number : 8260006
London, London, City of, United Kingdom
Investigational Site Number : 8260003
Warrington, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free number for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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DRI16804 Ulcerative Colitis website
DRI16804 Plain Language Results Summary
Other Identifiers
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U1111-1269-6212
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-500290-14
Identifier Type: REGISTRY
Identifier Source: secondary_id
DRI16804
Identifier Type: -
Identifier Source: org_study_id