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

NCT05588843 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: DRI16804U1111-1269-62122022-500290-14
• Study Type: interventional
• Target: 187
• Locations: 19 countries
• Sites: 106

Brief 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.

Conditions

Colitis Ulcerative

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve clinical remission at Week 12 by modified Mayo Score (mMS)

  The Mayo score (full MS) is a composite instrument that consists of patient reported stool frequency and rectal bleeding, endoscopy-derived measures and physician-reported assessment (PGA). The modified Mayo score is calculated omitting PGA. And an endoscopy score of 1 with no friability.

  At Week 12

Secondary Outcomes (16)

• Proportion of participants who achieve endoscopic improvement at Week 12

  At Week 12

• Proportion of participants who achieve clinical response at Week 12 by mMS

  At Week 12

• Proportion of participants who achieve clinical remission at Week 12 by full Mayo Score (MS)

  At Week 12

• Proportion of participants who achieve clinical response at Week 12 by MS.

  At Week 12

• Change from baseline on patient-reported outcome 2 (PRO2) total score (Mayo stool frequency and rectal bleeding subscores) over time

  From baseline to Week 12

Study Arms (4)

SAR443122 level 1

EXPERIMENTAL

Dose level 1

Drug: SAR443122

SAR443122 level 2

EXPERIMENTAL

Dose level 2

Drug: SAR443122

SAR443122 level 3

EXPERIMENTAL

Dose level 3

Drug: SAR443122

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

SAR443122 DRUG

oral capsule

SAR443122 level 1; SAR443122 level 2; SAR443122 level 3

Placebo DRUG

oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (106)

Om Research - Lancaster - 15th Street West- Site Number : 8400014

Lancaster, California, 93534, United States

Location

Agile Clinical Research Trials- Site Number : 8400024

Atlanta, Georgia, 30328, United States

Location

Endeavor Health - Evanston Hospital- Site Number : 8400027

Evanston, Illinois, 60201, United States

Location

BVL Research- Site Number : 8400015

Liberty, Missouri, 64068, United States

Location

Vector Clinical Trials- Site Number : 8400004

Las Vegas, Nevada, 89128, United States

Location

Sanmora Bespoke Clinical Research Solutions- Site Number : 8400016

East Orange, New Jersey, 07018, United States

Location

NY Scientific- Site Number : 8400013

Brooklyn, New York, 11235, United States

Location

Pioneer Clinical Research - New York- Site Number : 8400017

New York, New York, 10016, United States

Location

Gastro One - Walnut Run Road- Site Number : 8400002

Cordova, Tennessee, 38018, United States

Location

Houston Methodist Hospital- Site Number : 8400023

Houston, Texas, 77030, United States

Location

1960 Family Practice- Site Number : 8400019

Houston, Texas, 77090, United States

Location

GI Alliance - Mansfield- Site Number : 8400010

Mansfield, Texas, 76063, United States

Location

Integrity Research - Sugar Land- Site Number : 8400026

Sugar Land, Texas, 77478, United States

Location

Richmond VA Medical Center- Site Number : 8400022

Richmond, Virginia, 23249, United States

Location

Investigational Site Number : 0320006

CABA, Buenos Aires, C1023AAB, Argentina

Location

Investigational Site Number : 0320003

Rosario, Santa Fe Province, 2002, Argentina

Location

Investigational Site Number : 0320001

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Investigational Site Number : 0320002

Buenos Aires, 1128, Argentina

Location

Investigational Site Number : 0320004

Córdoba, 5000, Argentina

Location

Investigational Site Number : 0320005

Córdoba, 5000, Argentina

Location

Investigational Site Number : 0320007

Salta, 4400, Argentina

Location

Investigational Site Number : 1520004

Talcahuano, Biobio, 2687000, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7500010, Chile

Location

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, 7620001, Chile

Location

Investigational Site Number : 1520006

Santiago, Reg Metropolitana de Santiago, 8380456, Chile

Location

Investigational Site Number : 1520007

Viña del Mar, Valparaiso, 2540364, Chile

Location

Investigational Site Number : 1560001

Guangzhou, 510655, China

Location

Investigational Site Number : 1560004

Hangzhou, 310016, China

Location

Investigational Site Number : 1560003

Hefei, 230022, China

Location

Investigational Site Number : 1560006

Nanchang, 330006, China

Location

Investigational Site Number : 1560007

Nanjing, 210008, China

Location

Investigational Site Number : 1560005

Shanghai, 200025, China

Location

Investigational Site Number : 1560002

Shenyang, 110004, China

Location

Investigational Site Number : 2030007

České Budějovice, 370 01, Czechia

Location

Investigational Site Number : 2030001

Hradec Králové, 500 12, Czechia

Location

Investigational Site Number : 2030002

Klatovy, 339 01, Czechia

Location

Investigational Site Number : 2030003

Prague, 190 00, Czechia

Location

Investigational Site Number : 2500007

Marseille, 13915, France

Location

Investigational Site Number : 2500008

Nantes, 44314, France

Location

Investigational Site Number : 2500006

Neuilly-sur-Seine, 92200, France

Location

Investigational Site Number : 2500001

Vandœuvre-lès-Nancy, 54511, France

Location

Investigational Site Number : 2680003

Batumi, 6000, Georgia

Location

Investigational Site Number : 2680005

Kutaisi, 4600, Georgia

Location

Investigational Site Number : 2680002

Tbilisi, 0160, Georgia

Location

Investigational Site Number : 2680004

Tbilisi, 0186, Georgia

Location

Investigational Site Number : 6420001

Düsseldorf, 40225, Germany

Location

Investigational Site Number : 2760003

Fulda, 36043, Germany

Location

Investigational Site Number : 2760001

Kiel, 24105, Germany

Location

Investigational Site Number : 2760008

Ludwigshafen, 67067, Germany

Location

Investigational Site Number : 2760006

Ulm, 89081, Germany

Location

Investigational Site Number : 3480001

Békéscsaba, 5600, Hungary

Location

Investigational Site Number : 3480005

Budapest, 1062, Hungary

Location

Investigational Site Number : 3480002

Budapest, 1085, Hungary

Location

Investigational Site Number : 3480006

Gyöngyös, 3200, Hungary

Location

Investigational Site Number : 3560003

Gurgaon, 122002, India

Location

Investigational Site Number : 3560009

Jaipur, 302001, India

Location

Investigational Site Number : 3560001

Jaipur, 302007, India

Location

Investigational Site Number : 3560005

Kochi, 682017, India

Location

Investigational Site Number : 3560004

Ludhiana, 141010, India

Location

Investigational Site Number : 3560013

New Delhi, 110029, India

Location

Investigational Site Number : 3560007

Pune, 411001, India

Location

Investigational Site Number : 3560008

Rajkot, 360005, India

Location

Investigational Site Number : 3560012

Secunderabad, 500003, India

Location

Investigational Site Number : 3560010

Surat, 395002, India

Location

Investigational Site Number : 3560011

Surat, 395009, India

Location

Investigational Site Number : 3560006

Thiruvananthapuram, 695011, India

Location

Investigational Site Number : 3800008

Bolzano, Bolzano / Bozen, 39100, Italy

Location

Investigational Site Number : 3800007

Milan, Milano, 20097, Italy

Location

Investigational Site Number : 3800005

Rozzano, Milano, 20089, Italy

Location

Investigational Site Number : 3800002

Rome, Roma, 00168, Italy

Location

Investigational Site Number : 3800004

Catanzaro, 88100, Italy

Location

Investigational Site Number : 3800003

Milan, 20132, Italy

Location

Investigational Site Number : 3800006

Palermo, 90146, Italy

Location

Investigational Site Number : 3800001

Pavia, 27100, Italy

Location

Investigational Site Number : 3920011

Nagaoka, Niigata, 940-2108, Japan

Location

Investigational Site Number : 3920005

Hamamatsu, Shizuoka, 432-8061, Japan

Location

Investigational Site Number : 3920007

Chūō, Tokyo, 104-0061, Japan

Location

Investigational Site Number : 3920002

Fukushima, 720-0825, Japan

Location

Investigational Site Number : 3920003

Osaka, 540-0006, Japan

Location

Investigational Site Number : 3920001

Ōita, 870-0823, Japan

Location

Investigational Site Number : 3920006

Saitama, 330-8553, Japan

Location

Investigational Site Number : 4840005

Mérida, Yucatán, 97070, Mexico

Location

Investigational Site Number : 4840001

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 4840003

Chihuahua City, 31203, Mexico

Location

Investigational Site Number : 4840002

Durango, 34000, Mexico

Location

Investigational Site Number : 4840006

Tlalnepantla, 54055, Mexico

Location

Investigational Site Number : 5280001

Amsterdam, 1081 HV, Netherlands

Location

Investigational Site Number : 5280002

Nijmegen, 6525 GA, Netherlands

Location

Investigational Site Number : 6160018

Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland

Location

Investigational Site Number : 6160004

Wroclaw, Lower Silesian Voivodeship, 50-162, Poland

Location

Investigational Site Number : 6160010

Łęczna, Lublin Voivodeship, 21-010, Poland

Location

Investigational Site Number : 6160002

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Investigational Site Number : 6160017

Warsaw, Masovian Voivodeship, 02-786, Poland

Location

Investigational Site Number : 6160006

Gdynia, Pomeranian Voivodeship, 81-384, Poland

Location

Investigational Site Number : 6160009

Katowice, Silesian Voivodeship, 40-748, Poland

Location

Investigational Site Number : 6160011

Tychy, Silesian Voivodeship, 43-100, Poland

Location

Investigational Site Number : 6160016

Katowice, 40-600, Poland

Location

Investigational Site Number : 6160015

Krakow, 31-156, Poland

Location

Investigational Site Number : 6420002

Cluj-Napoca, 400006, Romania

Location

Investigational Site Number : 7030003

Banská Bystrica, 975 17, Slovakia

Location

Investigational Site Number : 7030002

Košice, 040 13, Slovakia

Location

Investigational Site Number : 7030001

Nitra, 949 01, Slovakia

Location

Investigational Site Number : 7240006

Barcelona, Barcelona [Barcelona], 08022, Spain

Location

Investigational Site Number : 8260002

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

Investigational Site Number : 8260006

London, London, City of, SE1 9RT, United Kingdom

Location

Investigational Site Number : 8260003

Warrington, WA5 1LZ, United Kingdom

Location

Related Links

• DRI16804 Ulcerative Colitis website
• DRI16804 Plain Language Results Summary

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: November 25, 2022
• Primary Completion: February 10, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SL (3); NL (2); GE (4); IT (8); DE (5); US (14); CZ (4); IN (12); JP (7); HU (4); ME (5); CN (7); RO (1); FR (4); PL (10); AR (7); CL (5); ES (1); GB (3)