A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
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.
210 participants
Nov 3, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria3
- Have certain infections or other immune conditions.
- Recently used medications that could interfere with the study.
- Are pregnant or breastfeeding.
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Interventions
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.
Placebo for BFB759
Locations(58)
View Full Details on ClinicalTrials.gov
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NCT07287644