A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

NCT07287644 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: CL-BFB759-003COMPASS 2-HS
• Study Type: interventional
• Target: 210
• Locations: 7 countries
• Sites: 58

Brief 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)

Keywords

Hidradenitis Suppurativa; acne inversa

Outcome Measures

Primary Outcomes (1)

• Efficacy of BFB759 in HS

  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).

  Baseline to Week 16 and baseline to Week 32

Secondary Outcomes (5)

• Evaluate the clinical activity of BFB759 using HiSCR50

  Baseline to Week 16 and baseline to Week 32

• Evaluate the safety/tolerability of BFB759

  routinely over 21 months (about 22 visits during the course of study)

• To evaluate the clinical activity of BFB759 using the International Hidradenitis Suppurativa Severity Score System (IHS4)

  Baseline to Week 16 and baseline to Week 32

• To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS)

  Baseline to Week 16 and baseline to Week 32

• To evaluate the clinical activity of BFB759 using the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA)

  Baseline to Week 16 and baseline to Week 32

Study Arms (3)

Active - high dose

EXPERIMENTAL

BFB759 loading dose followed by BFB759 maintenance high dose every 2 weeks (Q2W) through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive).

Biological: BFB759

Active - low dose

EXPERIMENTAL

BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 14 (inclusive).

Biological: BFB759

Placebo

PLACEBO COMPARATOR

Placebo Q2W for 14 weeks. At Week 16, participants in Placebo group who are still enrolled in the study and receiving treatment will be re-randomized (1:1) into 2 groups (Cross 1 and Cross 2) to receive BFB759 * Cross 1 will receive BFB759 loading dose followed by BFB759 maintenance low-dose Q2W through Week 30 (inclusive). * Cross 2 will receive BFB759 loading dose followed by BFB759 maintenance mid-dose Q2W through Week 30 (inclusive).

Other: Placebo for BFB759

Interventions

BFB759 BIOLOGICAL

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.

Active - high dose; Active - low dose

Placebo for BFB759 OTHER

Placebo for BFB759

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have certain infections or other immune conditions.
• Recently used medications that could interfere with the study.
• Are pregnant or breastfeeding.

Sponsors & Collaborators

• Bluefin Biomedicine, Inc.: lead

Study Sites (58)

Saguaro Dermatology

Phoenix, Arizona, 85008, United States

RECRUITING

Encino Research Center

Encino, California, 91436, United States

RECRUITING

Clinical Science Institute

Santa Monica, California, 90404, United States

RECRUITING

Skin Care Research

Boca Raton, Florida, 33021, United States

RECRUITING

Center for Skin Science and Innovation

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Ziaderm Research LLC

North Miami Beach, Florida, 33126, United States

RECRUITING

Clinical Trials Management, LLC

Tampa, Florida, 33607, United States

RECRUITING

DelRicht Research

Atlanta, Georgia, 30329, United States

RECRUITING

Southeast Research Specialist LLC

Douglasville, Georgia, 30135, United States

RECRUITING

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

RECRUITING

DS Research of Kentucky

Louisville, Kentucky, 40241, United States

RECRUITING

Martha Stewart

Mandeville, Louisiana, 70448, United States

RECRUITING

Clinical Trials Management, LLC

Metairie, Louisiana, 70006, United States

RECRUITING

DelRicht Research

New Orleans, Louisiana, 70115, United States

RECRUITING

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

RECRUITING

MI Skin Innovations

Northville, Michigan, 48167, United States

RECRUITING

DelRicht Research

Wildwood, Missouri, 63040, United States

RECRUITING

JDR Dermatology Research LLC

Las Vegas, Nevada, 89145, United States

RECRUITING

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

RECRUITING

Schweiger Dermatology, PC

Hackensack, New Jersey, 07601, United States

RECRUITING

Equity Medical LLC

The Bronx, New York, 10455, United States

RECRUITING

Optima Research - Boardman

Boardman, Ohio, 44512, United States

RECRUITING

Apex Clinical Research Center, LLC

Canton, Ohio, 44718, United States

RECRUITING

Apex Clinical Research Center, LLC

Mayfield Heights, Ohio, 44124, United States

RECRUITING

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Medical Univ of SC Department of Dermatology

Charleston, South Carolina, 29425, United States

RECRUITING

DelRicht Research

Mt. Pleasant, South Carolina, 29464, United States

RECRUITING

DelRicht Research

Smyrna, Tennessee, 37167, United States

RECRUITING

DelRicht Research

Prosper, Texas, 75078, United States

RECRUITING

Stryde Research-Epiphany Dermatology

Southlake, Texas, 76092, United States

RECRUITING

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

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, L4B 1L1, Canada

RECRUITING

North York Research Inc.

Toronto, Ontario, M2N 3A6, Canada

RECRUITING

CCR Ostrava s.r.o.

Ostrava, Czechia

RECRUITING

Pratia Pardubice a.s.

Pardubice, Czechia

RECRUITING

Sanatorium of Professor Arenbergera

Prague, Czechia

RECRUITING

St. Josef-Hospital Bochum

Bochum, Germany

RECRUITING

Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie

Frankfurt, Germany

RECRUITING

University Clinic Dermatology Heidelberg

Heidelberg, Germany

RECRUITING

University Hospital, Leipzig

Leipzig, Germany

RECRUITING

University of Luebeck

Lübeck, Germany

RECRUITING

Klinik und Poliklinik fur Dermatologie und Allergologie

Munich, Germany

RECRUITING

NZOZ Specjal. Osrodek Dermatologiczny DERMAL

Bialystok, Poland

RECRUITING

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

Lublin, Poland

RECRUITING

Melita Medical

Wroclaw, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Poland

RECRUITING

Wojewódzki Szpital Specjalistyczny we Wrocławi,Oddział Dermatologiczny

Wroclaw, Poland

RECRUITING

Hospital Universitario Virgen De Las Nieves

Granada, Spain

RECRUITING

Hospital Asil de Granollers

Granollers, Spain

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Spain

RECRUITING

Hospital Gregorio Maranon

Madrid, Spain

RECRUITING

Complejo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

RECRUITING

Hospital de Manises

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Rob Eichelkraut

CONTACT

+1-214-728-6505; Reichelkraut@bluefinbiomed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 17, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6); US (31); BU (5); CA (2); CZ (3); PL (5); DE (6)