A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Patients with Moderate to Severe Hidradenitis Suppurativa

The primary objective of this study is to evaluate the efficacy of BFB759 in adults with moderate to severe hidradenitis suppurativa, specifically measured by the absolute count of abscesses and inflammatory nodules. The secondary objectives include assessing the efficacy of various dose regimens using several clinical endpoints:

• Hidradenitis suppurativa Clinical Response (HiSCR50, HiSCR75, and HiSCR90)
• International Hidradenitis Suppurativa Severity Score System (IHS4)
• Skin Pain as measured by a numerical rating scale (NRS)

This clinical trial involves 87 participants diagnosed with hidradenitis suppurativa. The study population consists of adult males and females between the ages of 18 and 75 years. Eligible subjects must have a confirmed diagnosis of the condition for a minimum of one year and present with moderate to severe disease that is inadequately managed by systemic antibiotic therapy. The primary objective is to evaluate the efficacy of BFB759 by assessing the count of abscesses and inflammatory nodules.

This Phase 2, dose ranging, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of BFB759 in adults diagnosed with moderate to severe hidradenitis suppurativa. Participants will receive either the test substance via subcutaneous injection or a placebo. The primary efficacy endpoint is the percent change from baseline at week 16 in the count of abscesses and inflammatory nodules. Secondary endpoints include the proportion of participants meeting HiSCR criteria, changes in the IHS4 score, and skin pain assessment using the NRS. Safety will be monitored through the incidence and severity of treatment-emergent adverse events. The clinical trial is estimated to take place between March 2026 and August 2027.

The experimental medication is BFB759, administered as a subcutaneous injection. This investigational product is provided in an injection pharmaceutical form for the management of hidradenitis suppurativa.

A placebo is utilized as a comparator treatment in this study. The administration of the placebo serves to maintain the double-blind nature of the clinical trial.

The efficacy of BFB759 in patients with hidradenitis suppurativa is evaluated through several parameters. The primary endpoint is the percent change from baseline at week 16 in the count of abscesses and inflammatory nodules compared to the placebo group. Secondary efficacy assessments include the proportion of participants meeting HiSCR50, HiSCR75, and HiSCR90 criteria at week 16. These criteria require at least a 50%, 75%, or 90% decrease in the count of abscesses and inflammatory nodules, respectively, with no increase in the number of abscesses or drainage tunnels relative to baseline.

Additional secondary endpoints involve the assessment of clinical scores and pain levels. These include the percent change from baseline at week 16 on the IHS4 and the skin pain NRS. Furthermore, the proportion of participants achieving an IHS4-55 or IHS4-90 response, defined as a 55% or 90% reduction in the IHS4 score at week 16 relative to baseline, will be analyzed.