A Phase 2, Dose Ranging, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Patients With Moderate to Severe Hidradenitis Suppurativa
Bluefin Biomedicine, Inc.
Summary
This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks. The study compares how well BFB759 works and how safe it is compared with a placebo.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Are adults (18 to 75 years) with a diagnosis of hidradenitis suppurativa for at least one year. * Have moderate to severe disease not well controlled by systemic antibiotic treatment. * Are willing to follow study instructions, attend regular visits, and avoid certain other medications during the study. Exclusion Criteria: * Have certain infections or other immune conditions. * Recently used medications that could interfere with the study. * Are pregnant or breastfeeding.
Interventions
- BiologicalBFB759
BFB759 is a human mAb that inhibits multiple pro-inflammatory cytokines that contribute to the pathogenesis of multiple disease processes characterized by aberrant inflammation, including hidradenitis suppurativa.
- OtherPlacebo for BFB759
Placebo for BFB759
Locations (33)
- Saguaro DermatologyPhoenix, Arizona
- Encino Research CenterEncino, California
- Clinical Science InstituteSanta Monica, California
- Skin Care ResearchBoca Raton, Florida
- Center for Skin Science and InnovationFort Lauderdale, Florida
- Ziaderm Research LLCNorth Miami Beach, Florida