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Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Study acronym: BRIGHTEN
StatusRecruiting
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Trial sites expanded: 79 → 85 locations
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 4 of 10 entries
  2. Minor Primary completion moved earlier from Aug 1, 2027 to Feb 9, 2027
    • Study completion pushed from Apr 27, 2028 to Nov 23, 2029
    • Secondary endpoints: details revised at 3 of 10 entries
    v11
  3. Minor Trial sites expanded: 76 → 79 locationsv10
  4. Minor Trial sites expanded: 69 → 76 locationsv9
  5. Minor Trial sites expanded: 54 → 69 locationsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Study sites revised (54)v7
  2. Minor Enrollment target: 188 to 208
    • Study sites: 37 to 54
    • Secondary endpoints revised (10)
    v6
  3. Minor Study sites: 14 to 37v5
  4. Minor Study sites: 12 to 14v4
  5. Minor Study sites: 8 to 12v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 8
    • Start date changed from estimate of Oct 14, 2025 to Nov 6, 2025
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 164 weeks for participants transitioning into the long-term extension (LTE) period and will be up to approximately 60 weeks for participants not transitioning into the LTE period. The randomized treatment duration will be up to approximately 152 weeks
Trial Details
NCT Number NCT07170917
Lead Sponsor Sanofi
Conditions
(from sponsor)
Hidradenitis Suppurativa
Related terms Hidradenitis Suppurativa
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov