A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Sanofi
Study ID
NCT07225569
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SAR445399 — DRUG
    Pharmaceutical form: Solution for injection -Route of administration: Injection
  • Placebo — DRUG
    Pharmaceutical form: Solution for injection -Route of administration: Injection

Study Details

This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa. The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa. The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.

Key Dates

Start date
Dec 29, 2025
Status verified
May 2026
Primary completion
Sep 22, 2027
Completion
Dec 1, 2027

Study Design

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

Arms

  • Experimental: SAR445399 dose regimen A
    Participants will receive SAR445399 dose regimen A.
  • Experimental: SAR445399 dose regimen B
    Participants will receive SAR445399 dose regimen B.
  • Placebo Comparator: Placebo
    Participants will receive SAR445399-matching placebo.

Primary Outcome Measure

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [ Time Frame: Up to Week 16 ]

Central Contacts

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

Locations (16)

FacilityCityStateZIPSite coordinators
Scottsdale Clinical Trials- Site Number : 8400006ScottsdaleArizona85260-
Carbon Health - North Hollywood - NoHo West- Site Number : 8400017North HollywoodCalifornia91606-
Encore Medical Research of Boynton Beach- Site Number : 8400005Boynton BeachFlorida33436-
FXM Clinical Research - Fort Lauderdale- Site Number : 8400013Fort LauderdaleFlorida33308-
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007Fort MyersFlorida33912-
Encore Medical Research - Hollywood- Site Number : 8400004HollywoodFlorida33024-
Florida International Research Center- Site Number : 8400002MiamiFlorida33173-
Florida Research Center- Site Number : 8400009MiamiFlorida33174-
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014MiamiFlorida33146-
Advanced Clinical Research Institute- Site Number : 8400021TampaFlorida33607-
Cleaver Medical Group Dermatology- Site Number : 8400008CummingGeorgia30040-
First Georgia Physician Group- Site Number : 8400033FayettevilleGeorgia30214-
Essential Medical Research- Site Number : 8400015Overland ParkKansas66213-
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026LouisvilleKentucky40241-
Equity Medical- Site Number : 8400010New YorkNew York10023-
Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020The WoodlandsTexas77380-

Find similar trials in Scottsdale, AZ

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Scottsdale Clinical Trials· Scottsdale, AZCarbon Health - North Hollywood - NoHo West· North Hollywood, CAEncore Medical Research of Boynton Beach· Boynton Beach, FLFXM Clinical Research - Fort Lauderdale· Fort Lauderdale, FLAlliance for Multispeciality Research - Fort Myers· Fort Myers, FLEncore Medical Research - Hollywood· Hollywood, FL

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