A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

NCT07287644 · tracked via the Priya Life Science USA tracker

Sponsor

Bluefin Biomedicine, Inc.

Phase

Phase 2/3

Started

2025-11-03

Last updated

2026-05-29

Condition(s) studied

Hidradenitis Suppurativa (HS)

Investigational drug(s) / intervention(s)

BFB759Placebo for BFB759

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.

Placebo for BFB759: Placebo for BFB759

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Efficacy of BFB759 in HS — Baseline to Week 16 and baseline to Week 32
To evaluate the efficacy of BFB759 in adult male and female participants with HS as measured by the change in the number of abscesses and inflammatory nodules (AN count).

Trial sites (58)

Facility	City	Region	Status
Saguaro Dermatology	Phoenix	Arizona	Recruiting
Encino Research Center	Encino	California	Recruiting
Clinical Science Institute	Santa Monica	California	Recruiting
Skin Care Research	Boca Raton	Florida	Recruiting
Center for Skin Science and Innovation	Fort Lauderdale	Florida	Recruiting
Ziaderm Research LLC	North Miami Beach	Florida	Recruiting
Clinical Trials Management, LLC	Tampa	Florida	Recruiting
DelRicht Research	Atlanta	Georgia	Recruiting
Southeast Research Specialist LLC	Douglasville	Georgia	Recruiting
The Indiana Clinical Trials Center, PC	Plainfield	Indiana	Recruiting
DS Research of Kentucky	Louisville	Kentucky	Recruiting
Martha Stewart	Mandeville	Louisiana	Recruiting
Clinical Trials Management, LLC	Metairie	Louisiana	Recruiting
DelRicht Research	New Orleans	Louisiana	Recruiting
Oakland Hills Dermatology	Auburn Hills	Michigan	Recruiting
MI Skin Innovations	Northville	Michigan	Recruiting
DelRicht Research	Wildwood	Missouri	Recruiting
JDR Dermatology Research LLC	Las Vegas	Nevada	Recruiting
Skin Cancer and Dermatology Institute	Reno	Nevada	Recruiting
Schweiger Dermatology, PC	Hackensack	New Jersey	Recruiting
Equity Medical LLC	The Bronx	New York	Recruiting
Optima Research - Boardman	Boardman	Ohio	Recruiting
Apex Clinical Research Center, LLC	Canton	Ohio	Recruiting
Apex Clinical Research Center, LLC	Mayfield Heights	Ohio	Recruiting
UPMC Department of Dermatology	Pittsburgh	Pennsylvania	Recruiting
Medical Univ of SC Department of Dermatology	Charleston	South Carolina	Recruiting
DelRicht Research	Mt. Pleasant	South Carolina	Recruiting
DelRicht Research	Smyrna	Tennessee	Recruiting
DelRicht Research	Prosper	Texas	Recruiting
Stryde Research-Epiphany Dermatology	Southlake	Texas	Recruiting
Dermatology Specialists of Spokane	Spokane	Washington	Recruiting
Medical Center Medconsult Burgas EOOD	Burgas	Bulgaria	Recruiting
Medical Center Medconsult Pleven-Lovech Branch	Lovech	Bulgaria	Recruiting
Medical Center Medconsult Pleven OOD	Pleven	Bulgaria	Recruiting
Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD	Plovdiv	Bulgaria	Recruiting
Medical Center Rusemed	Rousse	Bulgaria	Recruiting
York Dermatology Clinical and Research Centre	Richmond Hill	Ontario	Recruiting
North York Research Inc.	Toronto	Ontario	Recruiting
CCR Ostrava s.r.o.	Ostrava	Czechia	Recruiting
Pratia Pardubice a.s.	Pardubice	Czechia	Recruiting

+ 18 more sites — see the full list on the official registry below.

More Bluefin Biomedicine, Inc. trials in the USA

A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis Active, not recruiting

Other trials for the same condition

Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Recruiting

A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa Recruiting

Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense Active, not recruiting

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib Recruiting

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07287644 on ClinicalTrials.gov ↗ ← All trials in the USA