Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
ConditionHidradenitis Suppurativa
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanofi
About this trial
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 criteria
Qualifiers
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 antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
Participants must be either biologic-naive or biologic-experienced.
Disqualifiers
Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
History of recurrent or recent serious infection
Known history of significant immunosuppression
History of solid organ transplant or stem cell transplant
Trial design
Treatments tested in this trial
- Brivekimig
- Placebo
Treatment groups
208 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov