A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

NCT07287644 | Active Not 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

Location

Encino Research Center

Encino, California, 91436, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Skin Care Research

Boca Raton, Florida, 33021, United States

Location

Center for Skin Science and Innovation

Fort Lauderdale, Florida, 33308, United States

Location

Ziaderm Research LLC

North Miami Beach, Florida, 33126, United States

Location

Clinical Trials Management, LLC

Tampa, Florida, 33607, United States

Location

DelRicht Research

Atlanta, Georgia, 30329, United States

Location

Southeast Research Specialist LLC

Douglasville, Georgia, 30135, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

DS Research of Kentucky

Louisville, Kentucky, 40241, United States

Location

Martha Stewart

Mandeville, Louisiana, 70448, United States

Location

Clinical Trials Management, LLC

Metairie, Louisiana, 70006, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

MI Skin Innovations

Northville, Michigan, 48167, United States

Location

DelRicht Research

Wildwood, Missouri, 63040, United States

Location

JDR Dermatology Research LLC

Las Vegas, Nevada, 89145, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

Schweiger Dermatology, PC

Hackensack, New Jersey, 07601, United States

Location

Equity Medical LLC

The Bronx, New York, 10455, United States

Location

Optima Research - Boardman

Boardman, Ohio, 44512, United States

Location

Apex Clinical Research Center, LLC

Canton, Ohio, 44718, United States

Location

Apex Clinical Research Center, LLC

Mayfield Heights, Ohio, 44124, United States

Location

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical Univ of SC Department of Dermatology

Charleston, South Carolina, 29425, United States

Location

DelRicht Research

Mt. Pleasant, South Carolina, 29464, United States

Location

DelRicht Research

Smyrna, Tennessee, 37167, United States

Location

DelRicht Research

Prosper, Texas, 75078, United States

Location

Stryde Research-Epiphany Dermatology

Southlake, Texas, 76092, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Medical Center Medconsult Burgas EOOD

Burgas, Bulgaria

Location

Medical Center Medconsult Pleven-Lovech Branch

Lovech, Bulgaria

Location

Medical Center Medconsult Pleven OOD

Pleven, Bulgaria

Location

Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD

Plovdiv, Bulgaria

Location

Medical Center Rusemed

Rousse, Bulgaria

Location

York Dermatology Clinical and Research Centre

Richmond Hill, Ontario, L4B 1L1, Canada

Location

North York Research Inc.

Toronto, Ontario, M2N 3A6, Canada

Location

CCR Ostrava s.r.o.

Ostrava, Czechia

Location

Pratia Pardubice a.s.

Pardubice, Czechia

Location

Sanatorium of Professor Arenbergera

Prague, Czechia

Location

St. Josef-Hospital Bochum

Bochum, Germany

Location

Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie

Frankfurt, Germany

Location

University Clinic Dermatology Heidelberg

Heidelberg, Germany

Location

University Hospital, Leipzig

Leipzig, Germany

Location

University of Luebeck

Lübeck, Germany

Location

Klinik und Poliklinik fur Dermatologie und Allergologie

Munich, Germany

Location

NZOZ Specjal. Osrodek Dermatologiczny DERMAL

Bialystok, Poland

Location

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

Lublin, Poland

Location

Melita Medical

Wroclaw, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Poland

Location

Wojewódzki Szpital Specjalistyczny we Wrocławi,Oddział Dermatologiczny

Wroclaw, Poland

Location

Hospital Universitario Virgen De Las Nieves

Granada, Spain

Location

Hospital Asil de Granollers

Granollers, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Spain

Location

Hospital Gregorio Maranon

Madrid, Spain

Location

Complejo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

Location

Hospital de Manises

Valencia, Spain

Location

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

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: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

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