A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

Evaluate the clinical activity of BFB759 using HiSCR50

The HiSCR50 is defined as at least a 50% reduction in inflammatory lesion count \[the sum of Abscesses and Inflammatory Nodules (AN)\] and no increase in abscess count and no increase in draining fistula count relative to baseline. The threshold of 50% reduction in AN count is the defined level that is clinically appropriate and meaningful to the patient regarding improvement in quality of life and pain level.

Time frame: Baseline to Week 16 and baseline to Week 32

Evaluate the safety/tolerability of BFB759

Record how well participants tolerate the treatment over time by recording the incidence and severity of treatment-emergent adverse events (as described by CTCAE Version 5.0)

Time frame: routinely over 21 months (about 22 visits during the course of study)

To evaluate the clinical activity of BFB759 using the International Hidradenitis Suppurativa Severity Score System (IHS4)

The IHS4 is a validated tool to dynamically assess HS severity that can be used both in real-life and the clinical trials setting (Zouboulis, 2017). It is calculated by counting nodules, abscesses and dTs/sinus tracts, and calculating a total score. IHS4 = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of dTs multiplied by 4\].

Time frame: Baseline to Week 16 and baseline to Week 32

To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS)

The Skin Pain NRS is a single self-reported item designed to measure skin pain severity over the previous 24 hours. The following question is asked, and the response is marked on an 11 point scale where 0 equals no pain and 10 equals the worst pain imaginable.