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ACTIVE NOT RECRUITING

NCT05588843

PHASE2

Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants with moderate to severe UC. Dose selection for further clinical development will be based on the multiple efficacy, safety and PK parameters. 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.

Official title: A Randomized, Double-blind, Placebo Controlled, Dose-finding Study to Assess the Efficacy and Safety of SAR443122 in Adult Patients With Moderate to Severe Ulcerative Colitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

187

Start Date

2022-11-25

Completion Date

2026-12-02

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Colitis Ulcerative

Interventions

DRUG

SAR443122

oral capsule

DRUG

Placebo

oral capsule

Inclusion Criteria: * Participants who have clinical evidence of active Ulcerative Colitis \[UC\] for ≥3 months before screening as confirmed by endoscopy during the screening period. * 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 Crohn's Disease (CD). * 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.

Locations (106)

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 : 0320006

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320003

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320001

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320004

Córdoba, Argentina

Investigational Site Number : 0320005

Córdoba, Argentina

Investigational Site Number : 0320007

Salta, 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

Gūrgaon, 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 : 3800005

Rozzano, Milano, Italy

Investigational Site Number : 3800002

Rome, Roma, Italy

Investigational Site Number : 3800004

Catanzaro, Italy

Investigational Site Number : 3800003

Milan, 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 : 8260002

Cambridge, Cambridgeshire, United Kingdom

Investigational Site Number : 8260006

London, London, City of, United Kingdom

Investigational Site Number : 8260003

Warrington, United Kingdom

Clinical Research Directory

Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (106)