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

Condition studied

Hidradenitis suppurativa

Eligibility

Primary endpoint

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

Endpoint detail

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90), Change from Baseline in draining tunnel count at Week 16., Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16, Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8, Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16., Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16., Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies., Serum brivekimig concentration throughout the study, Incidence of treatment-emergent (TE) anti-drug antibody responses.