Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Sanofi
Study ID
NCT07170917
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Brivekimig — DRUG
    * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
  • Placebo — DRUG
    * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

Study Details

This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa. The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS. Study details include: The study duration (per participant) will be up to approximately 60 weeks for participants not transitioning into the long-term extension (LTE) study and will be up to approximately 52 weeks for participants transitioning into the LTE study. The randomized treatment duration will be up to approximately 48 weeks.

Key Dates

Start date
Nov 6, 2025
Status verified
May 2026
Primary completion
Aug 1, 2027
Completion
Apr 27, 2028

Study Design

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

Arms

  • Experimental: Brivekimig dose regimen A
    Participants will receive Brivekimig dose regimen A.
  • Experimental: Brivekimig dose regimen B
    Participants will receive Brivekimig dose regimen B.
  • Experimental: Brivekimig dose regimen C
    Participants will receive Brivekimig dose regimen C.
  • Placebo Comparator: Placebo
    Participants will receive Brivekimig 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 (13)

FacilityCityStateZIPSite coordinators
Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014ScottsdaleArizona85259-
Northridge Clinical Trials - Northridge- Site Number : 8400005NorthridgeCalifornia91325-
FXM Clinical Research - Miami- Site Number : 8400017MiamiFlorida33175-
FXM Clinical Research - Miramar- Site Number : 8400004MiramarFlorida33027-
Advanced Medical Research - Atlanta- Site Number : 8400011AtlantaGeorgia30342-
Georgia Skin & Cancer Clinic- Site Number : 8400009SavannahGeorgia31419-
The Iowa Clinic West Des Moines Campus- Site Number : 8400007West Des MoinesIowa50266-
Louisiana Dermatology Associates- Site Number : 8400006Baton RougeLouisiana70809-
JDR Dermatology Research - Site number: 8400012Las VegasNevada89145-
Clinical Partners- Site Number : 8400002JohnstonRhode Island02919-
AMR Clinical South Strand, South Carolina- Site Number : 8400018Myrtle BeachSouth Carolina29588-
UT Southwestern Medical Center, Department of Dermatology- Site Number : 8400022DallasTexas75235-
Alpine Research Association- Site Number : 8400008LaytonUtah84041-

Find similar trials in Scottsdale, AZ

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Mayo Clinic in Arizona - Scottsdale· Scottsdale, AZNorthridge Clinical Trials - Northridge· Northridge, CAFXM Clinical Research - Miami· Miami, FLFXM Clinical Research - Miramar· Miramar, FLAdvanced Medical Research - Atlanta· Atlanta, GAGeorgia Skin & Cancer Clinic· Savannah, GA

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