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

Part of paid clinical trials in Escondido, California.

Sponsor
Sanofi
Study ID
NCT06975722
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SAR442970 — DRUG
    Route of administration: Subcutaneous
  • Placebo — DRUG
    Route of administration: Subcutaneous

Study Details

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.

Key Dates

Start date
Jul 7, 2025
Status verified
Apr 2026
Primary completion
Dec 17, 2026
Completion
Oct 17, 2029

Study Design

Enrollment
99 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAR442970 Dose Regimen A
    Participants will receive SAR442970 dose regimen A
  • Experimental: SAR442970 Dose Regimen B
    Participants will receive SAR442970 dose regimen B
  • Placebo Comparator: Placebo
    Participants will receive SAR442970-matching placebo

Primary Outcome Measure

Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS) [ Time Frame: At Week 16 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (21)

FacilityCityStateZIPSite coordinators
Investigational Site Number: 8400009EscondidoCalifornia92025-
Investigational Site Number: 8400006LancasterCalifornia93534-
Investigational Site Number: 8400025Thousand OaksCalifornia91360-
Investigational Site Number: 8400024JacksonvilleFlorida32258-
Investigational Site Number: 8400030KissimmeeFlorida347441-
Investigational Site Number: 8400003Lighthouse PTFlorida33064-
Investigational Site Number: 8400001MiamiFlorida33134-
Investigational Site Number: 8400011MiamiFlorida33136-
Investigational Site Number: 8400010Palmetto BayFlorida33176-
Investigational Site Number: 8400019TampaFlorida33609-
Investigational Site Number: 8400018MariettaGeorgia30060-
Investigational Site Number: 8400005Iowa CityIowa52242-
Investigational Site Number: 8400017BostonMassachusetts02115-
Investigational Site Number: 8400012WyomingMichigan49519-
Investigational Site Number: 8400014St LouisMissouri63110-
Investigational Site Number: 8400021New YorkNew York10029-
Investigational Site Number: 8400029Queens VillageNew York11428-
Investigational Site Number: 8400002Chapel HillNorth Carolina27514-
Investigational Site Number: 8400013HarrisburgPennsylvania17110-
Investigational Site Number: 8400023HoustonTexas77030-
Investigational Site Number: 8400007OgdenUtah84405-

Find similar trials in Escondido, CA

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
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