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NCT07287644PHASE2, PHASE3Recruiting

A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

Bluefin Biomedicine, Inc.

Start Date

11/3/2025

Completion Date

8/1/2027

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 Criteria

Age Range: 18 years to 75 years

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

BIOLOGICAL

BFB759

OTHER

Placebo for BFB759

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Conditions

Hidradenitis Suppurativa (HS)

Locations

Saguaro Dermatology

Phoenix, Arizona 85008

United States

Encino Research Center

Encino, California 91436

United States

Clinical Science Institute

Santa Monica, California 90404

United States

Skin Care Research

Boca Raton, Florida 33021

United States

Center for Skin Science and Innovation

Fort Lauderdale, Florida 33308

United States

Ziaderm Research LLC

North Miami Beach, Florida 33126

United States

Clinical Trials Management, LLC

Tampa, Florida 33607

United States

DelRicht Research

Atlanta, Georgia 30329

United States

Southeast Research Specialist LLC

Douglasville, Georgia 30135

United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana 46168

United States

DS Research of Kentucky

Louisville, Kentucky 40241

United States

Martha Stewart

Mandeville, Louisiana 70448

United States

Clinical Trials Management, LLC

Metairie, Louisiana 70006

United States

DelRicht Research

New Orleans, Louisiana 70115

United States

Oakland Hills Dermatology

Auburn Hills, Michigan 48326

United States

MI Skin Innovations

Northville, Michigan 48167

United States

DelRicht Research

Wildwood, Missouri 63040

United States

JDR Dermatology Research LLC

Las Vegas, Nevada 89145

United States

Skin Cancer and Dermatology Institute

Reno, Nevada 89509

United States

Schweiger Dermatology, PC

Hackensack, New Jersey 07601

United States

Equity Medical LLC

The Bronx, New York 10455

United States

Optima Research - Boardman

Boardman, Ohio 44512

United States

Apex Clinical Research Center, LLC

Canton, Ohio 44718

United States

Apex Clinical Research Center, LLC

Mayfield Heights, Ohio 44124

United States

UPMC Department of Dermatology

Pittsburgh, Pennsylvania 15213

United States

Medical Univ of SC Department of Dermatology

Charleston, South Carolina 29425

United States

DelRicht Research

Mt. Pleasant, South Carolina 29464

United States

DelRicht Research

Smyrna, Tennessee 37167

United States

DelRicht Research

Prosper, Texas 75078

United States

Stryde Research-Epiphany Dermatology

Southlake, Texas 76092

United States

Dermatology Specialists of Spokane

Spokane, Washington 99202

United States

Medical Center Medconsult Burgas EOOD

Burgas,

Bulgaria

Medical Center Medconsult Pleven-Lovech Branch

Lovech,

Bulgaria

Medical Center Medconsult Pleven OOD

Pleven,

Bulgaria

Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD

Plovdiv,

Bulgaria

Medical Center Rusemed

Rousse,

Bulgaria

York Dermatology Clinical and Research Centre

Richmond Hill, Ontario L4B 1L1

Canada

North York Research Inc.

Toronto, Ontario M2N 3A6

Canada

CCR Ostrava s.r.o.

Ostrava,

Czechia

Pratia Pardubice a.s.

Pardubice,

Czechia

Sanatorium of Professor Arenbergera

Prague,

Czechia

St. Josef-Hospital Bochum

Bochum,

Germany

Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie

Frankfurt,

Germany

University Clinic Dermatology Heidelberg

Heidelberg,

Germany

University Hospital, Leipzig

Leipzig,

Germany

University of Luebeck

Lübeck,

Germany

Klinik und Poliklinik fur Dermatologie und Allergologie

Munich,

Germany

NZOZ Specjal. Osrodek Dermatologiczny DERMAL

Bialystok,

Poland

Luxderm Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska

Lublin,

Poland

Melita Medical

Wroclaw,

Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw,

Poland

Wojewódzki Szpital Specjalistyczny we Wrocławi,Oddział Dermatologiczny

Wroclaw,

Poland

Hospital Universitario Virgen De Las Nieves

Granada,

Spain

Hospital Asil de Granollers

Granollers,

Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria,

Spain

Hospital Gregorio Maranon

Madrid,

Spain

Complejo Hospitalario Universitario de Pontevedra

Pontevedra,

Spain

Hospital de Manises

Valencia,

Spain