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

Last updated: February 20, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Placebo

SAR443122

Clinical Study ID

NCT05588843
DRI16804
2022-500290-14
2022-500290-14-01
U1111-1269-6212
  • Ages 18-75
  • All Genders

Study 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.

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

Total Participants: 182
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 25, 2022
Estimated Completion Date:
September 09, 2026

Study Description

Total study duration per participant will be up to 58 weeks, including a screening period of up to 4 weeks, a treatment period up to 52 weeks and a post-treatment follow-up period of 2 weeks.

Connect with a study center

  • Investigational Site Number : 0320002

    Caba, Buenos Aires C1128AAF
    Argentina

    Site Not Available

  • Investigational Site Number : 0320003

    Rosario, Santa Fe 2002
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320002

    Buenos Aires, 1128
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320004

    Córdoba, 5000
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320005

    Córdoba, 5000
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320001

    San Miguel de Tucuman, 4000
    Argentina

    Site Not Available

  • Investigational Site Number :0320001

    San Miguel de Tucuman, T4000AXL
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320001

    San Miguel de Tucumán, 4000
    Argentina

    Active - Recruiting

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana De Santiago 7500010
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana De Santiago 7620001
    Chile

    Active - Recruiting

  • Investigational Site Number :1520001

    Santiago, Reg Metropolitana De Santiago 7500010
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520004

    Talcahuano, 2687000
    Chile

    Active - Recruiting

  • Investigational Site Number : 1560001

    Guangzhou, 510655
    China

    Active - Recruiting

  • Investigational Site Number : 1560004

    Hangzhou, 310016
    China

    Active - Recruiting

  • Investigational Site Number : 1560003

    Hefei, 230022
    China

    Active - Recruiting

  • Investigational Site Number : 1560006

    Nanchang, 330006
    China

    Active - Recruiting

  • Investigational Site Number : 1560007

    Nanjing, 210008
    China

    Active - Recruiting

  • Investigational Site Number : 1560005

    Shanghai, 200025
    China

    Active - Recruiting

  • Investigational Site Number : 1560002

    Shenyang, 110004
    China

    Active - Recruiting

  • Investigational Site Number : 2030001

    Hradec Kralove, 50012
    Czechia

    Site Not Available

  • Investigational Site Number : 2030001

    Hradec Králové, 500 12
    Czechia

    Active - Recruiting

  • Investigational Site Number : 2030002

    Klatovy, 339 01
    Czechia

    Active - Recruiting

  • Investigational Site Number : 2030003

    Prague, 190 00
    Czechia

    Active - Recruiting

  • Investigational Site Number : 2030004

    Prague, 190 00
    Czechia

    Active - Recruiting

  • Investigational Site Number : 2030003

    Praha, 19000
    Czechia

    Site Not Available

  • Investigational Site Number : 2030004

    Praha, 19000
    Czechia

    Active - Recruiting

  • Investigational Site Number : 2500007

    Marseille, 13915
    France

    Active - Recruiting

  • Investigational Site Number : 2500006

    Neuilly Sur Seine, 92200
    France

    Site Not Available

  • Investigational Site Number : 2500006

    Neuilly-sur-seine, 92200
    France

    Active - Recruiting

  • Investigational Site Number : 2500001

    Vandoeuvre-les-nancy, 54511
    France

    Site Not Available

  • Investigational Site Number : 2500001

    Vandœuvre-lès-nancy, 54511
    France

    Active - Recruiting

  • Investigational Site Number : 2680003

    Batumi, 6000
    Georgia

    Active - Recruiting

  • Investigational Site Number : 2680002

    Tbilisi, 0160
    Georgia

    Active - Recruiting

  • Investigational Site Number : 2680004

    Tbilisi, 0186
    Georgia

    Active - Recruiting

  • Investigational Site Number : 2760001

    Kiel, 24105
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760008

    Ludwigshafen, 67067
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760004

    Nürtingen, 72622
    Germany

    Site Not Available

  • Investigational Site Number : 2760006

    ULM, 89081
    Germany

    Active - Recruiting

  • Investigational Site Number : 3480002

    Budapest, 1085
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480003

    Budapest, 1033
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480005

    Budapest, 1068
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480001

    Bã©kã©scsaba, 5600
    Hungary

    Site Not Available

  • Investigational Site Number : 3480001

    Békéscsaba, 5600
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480006

    Gyã¶ngyã¶s, 3200
    Hungary

    Site Not Available

  • Investigational Site Number : 3480006

    Gyöngyös, 3200
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3560003

    Gurgaon, 122002
    India

    Site Not Available

  • Investigational Site Number : 3560003

    Gurugram, 122002
    India

    Active - Recruiting

  • Investigational Site Number : 3560001

    Jaipur, 302004
    India

    Site Not Available

  • Investigational Site Number : 3560005

    Kochi, 682017
    India

    Active - Recruiting

  • Investigational Site Number : 3560004

    Ludhiana, 141010
    India

    Active - Recruiting

  • Investigational Site Number : 3560007

    Pune, 411001
    India

    Active - Recruiting

  • Investigational Site Number : 3560008

    Rajkot, 360005
    India

    Active - Recruiting

  • Investigational Site Number : 3560006

    Thiruvananthapuram, 695011
    India

    Active - Recruiting

  • Investigational Site Number : 3560001

    Vivekanand MARG, JAIPUR
    India

    Active - Recruiting

  • Investigational Site Number : 3800005

    Rozzano, Lombardia 20089
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800003

    Milan, Milano 20132
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800002

    Rome, Roma 00168
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800004

    Catanzaro, 88100
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800003

    Milano, 20132
    Italy

    Site Not Available

  • Investigational Site Number : 3800006

    Palermo, 90146
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800001

    Pavia, 27100
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800002

    Roma, 00168
    Italy

    Site Not Available

  • Investigational Site Number : 3800007

    San Donato Milanese, 20097
    Italy

    Active - Recruiting

  • Investigational Site Number : 3920004

    Kitakyushu, Fukuoka 802-0803
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920004

    Kokuraminami-ku Kitakyushu-shi, Fukuoka 802-8533
    Japan

    Site Not Available

  • Investigational Site Number : 3920002

    Fukushima, Hiroshima 720-0825
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920002

    Fukuyama-shi, Hiroshima 720-8520
    Japan

    Site Not Available

  • Investigational Site Number : 3920001

    Oita-shi, Oita 870-0823
    Japan

    Site Not Available

  • Investigational Site Number : 3920003

    Osaka-shi, Osaka 540-0006
    Japan

    Site Not Available

  • Investigational Site Number : 3920005

    Hamamatsu, Shizuoka 432-8061
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920005

    Hamamatsu-shi, Shizuoka 432-8061
    Japan

    Site Not Available

  • Investigational Site Number : 3920001

    Oita, 870-0823
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920003

    Osaka, 540-0006
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920006

    Saitama, 330-8553
    Japan

    Active - Recruiting

  • Investigational Site Number : 4840003

    Chihahua, Chihuahua 31203
    Mexico

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  • Investigational Site Number : 4840001

    Chihuahua, 31000
    Mexico

    Active - Recruiting

  • Investigational Site Number : 4840003

    Chihuahua, 31203
    Mexico

    Active - Recruiting

  • Investigational Site Number : 4840002

    Durango, 34000
    Mexico

    Active - Recruiting

  • Investigational Site Number : 5280001

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • Investigational Site Number : 5280002

    Nijmegen, 6525 GA
    Netherlands

    Active - Recruiting

  • Investigational Site Number : 5280004

    Tilburg, 5022 GC
    Netherlands

    Active - Recruiting

  • Investigational Site Number : 6160010

    Leczna, Lubuskie 21-010
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160005

    Pulawy, Lubuskie 24-100
    Poland

    Site Not Available

  • Investigational Site Number : 6160006

    Krakow, Malopolskie 31-501
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160002

    Warsaw, Mazowieckie 02-507
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160002

    Warszawa, Mazowieckie 02-507
    Poland

    Site Not Available

  • Investigational Site Number : 6160009

    Katowice, 40-748
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160004

    Wroclaw, 50-162
    Poland

    Active - Recruiting

  • Investigational Site Number : 7030003

    Banska Bystrica, 97401
    Slovakia

    Site Not Available

  • Investigational Site Number : 7030003

    Banská Bystrica, 975 17
    Slovakia

    Active - Recruiting

  • Investigational Site Number : 7030002

    Kosice, 04013
    Slovakia

    Site Not Available

  • Investigational Site Number : 7030002

    Košice, 040 13
    Slovakia

    Active - Recruiting

  • Investigational Site Number : 7030001

    Nitra, 949 01
    Slovakia

    Active - Recruiting

  • Investigational Site Number : 7240007

    Gijón, Asturias 33394
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona] 08022
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240001

    Madrid, Madrid, Comunidad De 28046
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240005

    Madrid, Madrid, Comunidad De 28006
    Spain

    Site Not Available

  • Investigational Site Number : 7240002

    Valencia, Valenciana, Comunidad 46007
    Spain

    Site Not Available

  • Investigational Site Number : 8260002

    Cambridge, Cambridgeshire CB2 2QQ
    United Kingdom

    Site Not Available

  • Investigational Site Number : 8260006

    London, London, City Of SE1 9RT
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260003

    Warrington, WA5 1LZ
    United Kingdom

    Active - Recruiting

  • Investigational Site Number :8260003

    Warrington, WA5 1QG
    United Kingdom

    Active - Recruiting

  • Om Research LLC- Site Number : 8400014

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Om Research Site Number : 8400014

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Om Research- Site Number : 8400014

    Lancaster, California 93534
    United States

    Active - Recruiting

  • United Medical Doctors Site Number : 8400005

    Los Alamitos, California 90720
    United States

    Site Not Available

  • United Medical Doctors-Site Number:8400005

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • Gastrointestinal Bioscience Site Number : 8400006

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Gastrointestinal Bioscience-Site Number:8400006

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • BVL Clinical Research Site Number : 8400015

    Liberty, Missouri 64068
    United States

    Active - Recruiting

  • BVL Clinical Research- Site Number : 8400015

    Liberty, Missouri 64068
    United States

    Active - Recruiting

  • BVL Research- Site Number : 8400015

    Liberty, Missouri 64068
    United States

    Active - Recruiting

  • Las Vegas Medical Research Site Number : 8400004

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Las Vegas Medical Research-Site Number:8400004

    Las Vegas, Nevada 89113
    United States

    Active - Recruiting

  • Vector Clinical Trials Site Number : 8400004

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Vector Clinical Trials- Site Number : 8400004

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Sanmora Bespoke Clinical Research Site Number : 8400016

    East Orange, New Jersey 07018
    United States

    Active - Recruiting

  • Sanmora Bespoke Clinical Research Solutions- Site Number : 8400016

    East Orange, New Jersey 07018
    United States

    Active - Recruiting

  • Sanmora Bespoke Clinical Research- Site Number : 8400016

    East Orange, New Jersey 07018
    United States

    Active - Recruiting

  • NY Scientific Site Number : 8400013

    Brooklyn, New York 11235
    United States

    Active - Recruiting

  • NY Scientific- Site Number : 8400013

    Brooklyn, New York 11235
    United States

    Active - Recruiting

  • Pioneer Clinical NY Site Number : 8400017

    New York, New York 10016
    United States

    Active - Recruiting

  • Pioneer Clinical NY- Site Number : 8400017

    New York, New York 10016
    United States

    Active - Recruiting

  • Pioneer Clinical Research - New York- Site Number : 8400017

    New York, New York 10016
    United States

    Active - Recruiting

  • Onsite Clinical Solutions-Site Number:8400003

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Gastro One Site Number : 8400002

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Gastro One- Site Number : 8400002

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Gastro One - Germantown- Site Number : 8400002

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • 1960 Family Practice- Site Number : 8400019

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Houston Methodist Hospital- Site Number : 8400023

    Houston, Texas 77030
    United States

    Active - Recruiting

  • GI Alliance - Mansfield- Site Number : 8400010

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • GI Alliance Research Site Number : 8400010

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • GI Alliance Research- Site Number : 8400010

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • Southern Star Research Institute- Site Number : 8400011

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Southern Star Research Site Number : 8400011

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Southern Star Research- Site Number : 8400011

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Integrity Research - Sugar Land- Site Number : 8400026

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

  • Integrity Research- Site Number : 8400026

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

  • Richmond VAMC- Site Number : 8400022

    Richmond, Virginia 23249
    United States

    Active - Recruiting

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