A Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study of Brivekimig Followed by a Maintenance Period in Participants With Moderate to Severe Hidradenitis Suppurativa
Sanofi
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline * Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III. * Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral ant…
Interventions
- DrugBrivekimig
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
- DrugPlacebo
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Locations (69)
- Northridge Clinical Trials - Northridge- Site Number : 8400005Northridge, California
- FXM Clinical Research - Miami- Site Number : 8400017Miami, Florida
- FXM Clinical Research Miramar, LLC - Site Number: 8400004Miramar, Florida
- Advanced Medical Research - Atlanta- Site Number : 8400011Atlanta, Georgia
- Georgia Skin & Cancer Clinic- Site Number : 8400009Savannah, Georgia
- The Iowa Clinic West Des Moines Campus- Site Number : 8400007West Des Moines, Iowa