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ACTIVE NOT RECRUITINGPhase2

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

Sponsor: Sanofi

NCT ID: NCT06975722

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
SAR442970 (drug), Placebo (drug)
How long the study runs
Study runs about 51 months (dates as stated)
About the drug or intervention
SAR442970 — drug: Route of administration: Subcutaneous · Placebo — drug: Route of administration: Subcutaneous
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
105
Started
2025-07-07
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for ulcerative colitis
  • • Phase2 - 105 participants
  • • This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with ulcerative colitis

Where?

  • • Northwich - Investigational Site Number: 8260002
  • • Bury - Investigational Site Number: 8260003
  • • London - Investigational Site Number: 8260001
  • • London - Investigational Site Number: 8260004

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Ulcerative Colitis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

Biomarkers mentioned

sample positivepathogens or positiveinfection or positiveconfirmed by positiveand negative

Treatment history

Treatments you must have had:

  • ✓ received prior treatment for UC (either "a" or "b" below or combination of both):

What the study is looking for

  • ✓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 agreement to take part
  • ✓Participants who have had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy...
  • ✓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 treatment with ≥1 approved AT such as a...

Who cannot take part

  • ✗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...
  • ✗Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in...
  • ✗Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic...
See the full criteria
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.

Where Is This Study? (4 UK sites)

Investigational Site Number: 8260002

Northwich CW9 7LS, United Kingdom

Investigational Site Number: 8260003

Bury BL9 7TD, United Kingdom

Investigational Site Number: 8260001

London E11 1NR, United Kingdom

Investigational Site Number: 8260004

London SE1 7EH, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-10