A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: ACT181342024-515241-41-00U1111-1305-7281
• Study Type: interventional
• Target: 99
• Locations: 12 countries
• Sites: 67

Brief Summary

This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Ulcerative Colitis. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS)

  Clinical remission is based on modified Mayo subscores. The mMS ranges from 0 to 9 with higher scores indicating greater disease severity.

  At Week 16

Secondary Outcomes (25)

• Proportion of participants who achieve endoscopic improvement at Week 16

  At Week 16

• Proportion of participants who achieve endoscopic improvement at Week 52

  At Week 52

• Proportion of participants who achieve endoscopic response at Week 16

  At Week 16

• Proportion of participants who achieve endoscopic response at Week 52

  At Week 52

• Proportion of participants who achieve endoscopic remission at Week 16

  At Week 16

Study Arms (3)

SAR442970 Dose Regimen A

EXPERIMENTAL

Participants will receive SAR442970 dose regimen A

Drug: SAR442970

SAR442970 Dose Regimen B

EXPERIMENTAL

Participants will receive SAR442970 dose regimen B

Drug: SAR442970; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will receive SAR442970-matching placebo

Drug: Placebo

Interventions

SAR442970 DRUG

Route of administration: Subcutaneous

SAR442970 Dose Regimen A; SAR442970 Dose Regimen B

Placebo DRUG

Route of administration: Subcutaneous

Placebo; SAR442970 Dose Regimen B

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 are eligible to be included in the study only if all of the following criteria apply:
• Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
• Participants who have had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
• Must have active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician Global Assessment (PGA), with a minimum Rectal Bleeding (RB) subscore ≥1, a minimum Stool Frequency (SF) subscore ≥1, mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a minimum disease extent of 15 cm from the anal verge
• Must have received prior treatment for UC (either "a" or "b" below or combination of both):
• History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or history of corticosteroid dependence (defined as an inability to successfully taper corticosteroids without recurrence of UC) AND history of no prior exposure to Advanced Therapies (ATs), such as a biologic agent used to treat UC or advanced small molecules used to treat UC
• History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent used to treat UC or advanced small molecules used to treat UC
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Participants with active Crohn's Disease (CD), indeterminate colitis or microscopic colitis
• Participants with fecal sample positive for culture/ova for aerobic pathogens or positive for Clostridium difficile B toxin in stools
• Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in the study
• Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic dysplasia except for adenoma
• Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition
• History of recurrent or recent serious infection within 4 weeks of screening, or infection(s) requiring hospitalization or treatment with IV anti-infectives within 30 days prior to baseline, or infections(s) requiring oral anti-infectives within 14 days prior to baseline, except as required as part of an anti-Tuberculosis (TB) regimen
• Known history of or suspected significant current immunosuppression.
• History or solid organ transplant or splenectomy
• History of moderate to severe congestive heart failure (New York Health Association Class III or IV), or recent cerebrovascular accident.
• History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
• Participants with a history of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin
• Participants with a diagnosis of inflammatory conditions other than UC (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc.)
• History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at Screening
• History of Interstitial Lung Disease

Sponsors & Collaborators

• Sanofi: lead

Study Sites (67)

Investigational Site Number: 8400009

Escondido, California, 92025, United States

RECRUITING

Investigational Site Number: 8400006

Lancaster, California, 93534, United States

RECRUITING

Investigational Site Number: 8400025

Thousand Oaks, California, 91360, United States

RECRUITING

Investigational Site Number: 8400024

Jacksonville, Florida, 32258, United States

RECRUITING

Investigational Site Number: 8400030

Kissimmee, Florida, 347441, United States

RECRUITING

Investigational Site Number: 8400003

Lighthouse PT, Florida, 33064, United States

RECRUITING

Investigational Site Number: 8400001

Miami, Florida, 33134, United States

RECRUITING

Investigational Site Number: 8400011

Miami, Florida, 33136, United States

RECRUITING

Investigational Site Number: 8400010

Palmetto Bay, Florida, 33176, United States

RECRUITING

Investigational Site Number: 8400019

Tampa, Florida, 33609, United States

RECRUITING

Investigational Site Number: 8400018

Marietta, Georgia, 30060, United States

RECRUITING

Investigational Site Number: 8400005

Iowa City, Iowa, 52242, United States

RECRUITING

Investigational Site Number: 8400017

Boston, Massachusetts, 02115, United States

RECRUITING

Investigational Site Number: 8400012

Wyoming, Michigan, 49519, United States

RECRUITING

Investigational Site Number: 8400014

St Louis, Missouri, 63110, United States

RECRUITING

Investigational Site Number: 8400021

New York, New York, 10029, United States

RECRUITING

Investigational Site Number: 8400029

Queens Village, New York, 11428, United States

RECRUITING

Investigational Site Number: 8400002

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Investigational Site Number: 8400013

Harrisburg, Pennsylvania, 17110, United States

RECRUITING

Investigational Site Number: 8400023

Houston, Texas, 77030, United States

RECRUITING

Investigational Site Number: 8400007

Ogden, Utah, 84405, United States

RECRUITING

Investigational Site Number: 0360003

Brisbane, Queensland, 4101, Australia

RECRUITING

Investigational Site Number: 0360001

Clayton, Victoria, 3168, Australia

RECRUITING

Investigational Site Number: 1560004

Huizhou, Ghangdong, 516001, China

RECRUITING

Investigational Site Number: 1560005

Guangzhou, Guangdong, 510655, China

RECRUITING

Investigational Site Number: 1560002

Nanjing, Jiangsu, 210029, China

RECRUITING

Investigational Site Number: 1560008

Suzhou, Jiangsu, 215006, China

RECRUITING

Investigational Site Number: 1560003

Wuxi, Jiangsu, 214023, China

RECRUITING

Investigational Site Number: 1560009

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Investigational Site Number: 1560001

Hangzhou, 310016, China

RECRUITING

Investigational Site Number: 1560007

Ningbo, 315010, China

RECRUITING

Investigational Site Number: 2030001

Brno, JM, 61500, Czechia

RECRUITING

Investigational Site Number: 2030002

Slaný, 27401, Czechia

RECRUITING

Investigational Site Number: 2500002

Lille, 59037, France

RECRUITING

Investigative Site: 2500006

Nice, 6200, France

RECRUITING

Investigational Site Number: 2500005

Pierre-Bénite, 69495, France

RECRUITING

Investigational Site Number: 2500001

Saint-Priest-en-Jarez, 42270, France

RECRUITING

Investigational Site Number: 2500003

Toulouse, 31400, France

RECRUITING

Investigational Site Number: 2500004

Vandœuvre-lès-Nancy, 54500, France

WITHDRAWN

Investigational Site Number: 2760001

Minden, Northwest, 32423, Germany

RECRUITING

Investigational Site Number: 2760005

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Investigational Site Number: 2760003

Ulm, 89081, Germany

RECRUITING

Investigational Site Number: 3480003

Budapest, 1066, Hungary

RECRUITING

Investigational Site Number: 3480002

Budapest, 1088, Hungary

RECRUITING

Investigational Site Number: 3480001

Vác, 2600, Hungary

RECRUITING

Investigational Site Number: 3920002

Kashiwa, Chiba, 277-0871, Japan

RECRUITING

Investigational Site Number: 3920006

Ōita, Oita Prefecture, 870-0033, Japan

RECRUITING

Investigational Site Number: 3920005

Hamamatsu, 431-3192, Japan

RECRUITING

Investigational Site Number: 3920003

Hirosaki, 036-8545, Japan

RECRUITING

Investigational Site Number: 3920001

Morioka, 020-8505, Japan

RECRUITING

Investigational Site Number: 3920004

Nishinomiya, 663-8501, Japan

RECRUITING

Investigational Site Number: 4980001

Chisinau, 2025, Moldova

RECRUITING

Investigational Site Number: 6160006

Wroclaw, Lower Silesian Voivodeship, 53-149, Poland

RECRUITING

Investigational Site Number: 6160002

Bydgoszcz, 85-229, Poland

RECRUITING

Investigational Site Number: 6160009

Chojnice, 89-600, Poland

RECRUITING

Investigational Site Number: 6160007

Katowice, 40-748, Poland

RECRUITING

Investigational Site Number: 6160005

Sopot, 81-756, Poland

RECRUITING

Investigational Site Number: 6160008

Tychy, 43-100, Poland

RECRUITING

Investigational Site Number: 6160004

Warsaw, 00-189, Poland

RECRUITING

Investigational Site Number: 6160003

Warsaw, 04-501, Poland

RECRUITING

Investigational Site Number: 6160001

Wroclaw, 52-210, Poland

RECRUITING

Investigational Site Number: 7240001

Las Palmas de Gran Canaria, 35010, Spain

RECRUITING

Investigational Site Number: 7240002

Madrid, 28046, Spain

RECRUITING

Investigational Site Number: 8260002

Northwich, CHW, CW9 7LS, United Kingdom

RECRUITING

Investigational Site Number: 8260003

Bury, BL9 7TD, United Kingdom

RECRUITING

Investigational Site Number: 8260001

London, E11 1NR, United Kingdom

RECRUITING

Investigational Site Number: 8260004

London, SE1 7EH, United Kingdom

RECRUITING

Related Links

• ACT18134 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

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

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: April 28, 2025
• First Posted: May 16, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): October 17, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (8); AU (2); US (21); JP (6); GB (4); ES (2); DE (3); MO (1); FR (6); CZ (2); HU (3); PL (9)