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Active, not recruiting Phase 2

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

NCT06975722 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 2
Started
2025-07-07
Last updated
2026-11-02

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

SAR442970 →Placebo

SAR442970: Route of administration: Subcutaneous

Placebo: Route of administration: Subcutaneous

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 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 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): 1. 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 approved Advanced Therapies (ATs), such as a biologic agent used to treat UC or advanced small molecules used to treat UC 2. 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 Exclusion Criteria: * 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), family history of demyelinating disease, 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 * Participants with any of the following results at Screening: * Positive Hepatitis B surface antigen (HBs Ag) or, * Positive total Hepatitis B core antibody (anti-HBcAB) * Positive Hepatitis C Virus (HCV) antibody confirmed by positive HCV Ribonucleic Acid (RNA) (participants with HCV antibody (HCVAb) and negative HCV RNA may be included). * Screening laboratory and other analyses showing abnormal results * History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcome measure(s)

  • Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS) — At Week 16
    Clinical remission is defined as a mMS of 0 to 2, including Stool Frequency (SF) subscore of 0 or 1, Rectal Bleeding (RB) subscore of 0 and modified Mayo Endoscopic (mMES) of 0 or 1 confirmed by central reader (score of 1 does not include friability)

Trial sites (69)

FacilityCityRegionStatus
Investigational Site Number: 8400027 Fairhope Alabama
Investigational Site Number: 8400009 Escondido California
Investigational Site Number: 8400006 Lancaster California
Investigational Site Number: 8400025 Thousand Oaks California
Investigational Site Number: 8400024 Jacksonville Florida
Investigational Site Number: 8400030 Kissimmee Florida
Investigational Site Number: 8400003 Lighthouse PT Florida
Investigational Site Number: 8400001 Miami Florida
Investigational Site Number: 8400011 Miami Florida
Investigational Site Number: 8400010 Palmetto Bay Florida
Investigational Site Number: 8400019 Tampa Florida
Investigational Site Number: 8400018 Marietta Georgia
Investigational Site Number: 8400005 Iowa City Iowa
Investigational Site Number: 8400028 Kansas City Kansas
Investigational Site Number: 8400017 Boston Massachusetts
Investigational Site Number: 8400012 Wyoming Michigan
Investigational Site Number: 8400014 St Louis Missouri
Investigational Site Number: 8400021 New York New York
Investigational Site Number: 8400029 Queens Village New York
Investigational Site Number: 8400023 Houston Texas
Investigational Site Number: 8400007 Ogden Utah
Investigational Site Number: 0360003 Brisbane Queensland
Investigational Site Number: 0360001 Clayton Victoria
Investigational Site Number: 360002 Murdoch Australia
Investigational Site Number: 1560004 Huizhou Ghangdong
Investigational Site Number: 1560005 Guangzhou Guangdong
Investigational Site Number: 1560002 Nanjing Jiangsu
Investigational Site Number: 1560008 Suzhou Jiangsu
Investigational Site Number: 1560003 Wuxi Jiangsu
Investigational Site Number: 1560009 Shanghai Shanghai Municipality
Investigational Site Number: 1560001 Hangzhou China
Investigational Site Number: 1560007 Ningbo China
Investigational Site Number: 2030001 Brno JM
Investigational Site Number: 2030002 Slaný Czechia
Investigational Site Number: 2500002 Lille France
Investigational Site Number: 2500007 Montpellier France
Investigational Site Number: 2500006 Nice France
Investigational Site Number: 2500005 Pierre-Bénite France
Investigational Site Number: 2500001 Saint-Priest-en-Jarez France
Investigational Site Number: 2760001 Minden Northwest

+ 29 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06975722 on ClinicalTrials.gov ↗ ← All trials in the USA