A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Sanofi
Study ID
NCT06958536
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 Crohn's disease. 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 Crohn's disease. 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
Jun 3, 2025
Status verified
Mar 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 placebo

Primary Outcome Measure

Percentage of participants who achieve endoscopic response at Week 16 [ Time Frame: From Baseline to Week 16 ]

Central Contacts

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

Locations (20)

FacilityCityStateZIPSite coordinators
Investigational Site Number: 8400024TucsonArizona85724-
Investigational Site Number: 8400005EscondidoCalifornia92025-
Investigational Site Number: 8400001LancasterCalifornia93534-
Investigational Site Number: 8400017KissimmeeFlorida34741-
Investigational Site Number: 8400015Lighthouse PTFlorida33064-
Investigational Site Number 8400028MiamiFlorida33134-
Investigational Site Number: 8400012MiamiFlorida33136-
Investigational Site Number: 8400007OrlandoFlorida32804-
Investigational Site Number: 8400011Palmetto BayFlorida33176-
Investigational Site Number: 8400019MariettaGeorgia30060-
Investigational Site Number: 8400025Iowa CityIowa52242-
Investigational Site Number: 8400006Kansas CityKansas66160-
Investigational Site Number: 8400022BostonMassachusetts02115-
Investigational Site Number: 8400008WyomingMichigan49519-
Investigational Site Number: 8400013St LouisMissouri63110-
Investigational Site Number: 8400003Chapel HillNorth Carolina27599-
Investigational Site Number: 8400009HarrisburgPennsylvania17110-
Investigational Site Number: 8400002FredericksburgTexas78229-
Investigational Site Number: 8400016OgdenUtah84405-
Investigational Site Number: 8400027RichmondVirginia23249-

Find similar trials in Tucson, AZ

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