NCT07287644

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Bluefin Biomedicine, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hidradenitis Suppurativa (HS)

Interventions

Type	Name	Description
BIOLOGICAL	BFB759	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.
OTHER	Placebo for BFB759	Placebo for BFB759

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-12-17
• Last updated: 2026-04-03

Locations

33 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study