Wildwood

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that targets multiple inflammatory cytokines, in adults with moderate to severe hidradenitis suppurativa HS that is not well controlled by systemic antibiotics. This double-blind, placebo-controlled study involves participants aged 18 to 75 years and aims to understand how well BFB759 works compared to a placebo over approximately 36 to 40 weeks. Participants will be randomly assigned to one of several groups. Some will receive a loading dose of BFB759 followed by either a high or mid maintenance dose every two weeks through Week 14. Others will receive a placebo every two weeks for 14 weeks, then, if still enrolled, be re-randomized to receive either a low or mid dose of BFB759 every two weeks from Week 16 through Week 30. This design allows comparison of different dosing regimens and the placebo effect. During the study, participants will attend about 22 visits over 21 months to monitor safety and effectiveness. Researchers will measure clinical activity using scales such as HiSCR50, the International Hidradenitis Suppurativa Severity Score System IHS4, Skin Pain Numerical Rating Scale, and the Hidradenitis Suppurativa-Investigator Global Assessment HS-IGA. Participants are expected to follow study instructions carefully, attend regular visits, and avoid certain medications. The primary outcomes focus on efficacy at Weeks 16 and 32, with ongoing safety assessments throughout the study.