Recruiting

Phase 2

Phase 3

BFB759A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

Sponsor:

Bluefin Biomedicine, Inc.

Code:

NCT07287644

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BFB759

Placebo for BFB759

Study Details

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)

Study ID

NCT07287644

Start date

Nov 3, 2025

Status verified date

May, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active - high dose

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).

experimental: Active - low dose

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

placebo comparator: Placebo

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).

Interventions

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

Primary outcome measure

Efficacy of BFB759 in HS [ Time Frame: Baseline to Week 16 and baseline to Week 32 ]

Central Contacts and Locations

Central contacts

Rob Eichelkraut

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

Locations

Saguaro Dermatology

Recruiting

Phoenix, Arizona, United States, 85008

Encino Research Center

Recruiting

Encino, California, United States, 91436

Clinical Science Institute

Recruiting

Santa Monica, California, United States, 90404

Skin Care Research

Recruiting

Boca Raton, Florida, United States, 33021

Center for Skin Science and Innovation

Recruiting

Fort Lauderdale, Florida, United States, 33308

Ziaderm Research LLC

Recruiting

North Miami Beach, Florida, United States, 33126

Clinical Trials Management, LLC

Recruiting

Tampa, Florida, United States, 33607

DelRicht Research

Recruiting

Atlanta, Georgia, United States, 30329

Southeast Research Specialist LLC

Recruiting

Douglasville, Georgia, United States, 30135

The Indiana Clinical Trials Center, PC

Recruiting

Plainfield, Indiana, United States, 46168

DS Research of Kentucky

Recruiting

Louisville, Kentucky, United States, 40241

Martha Stewart

Recruiting

Mandeville, Louisiana, United States, 70448

Clinical Trials Management, LLC

Recruiting

Metairie, Louisiana, United States, 70006

DelRicht Research

Recruiting

New Orleans, Louisiana, United States, 70115

Oakland Hills Dermatology

Recruiting

Auburn Hills, Michigan, United States, 48326

MI Skin Innovations

Recruiting

Northville, Michigan, United States, 48167

DelRicht Research

Recruiting

Wildwood, Missouri, United States, 63040

JDR Dermatology Research LLC

Recruiting

Las Vegas, Nevada, United States, 89145

Skin Cancer and Dermatology Institute

Recruiting

Reno, Nevada, United States, 89509

Schweiger Dermatology, PC

Recruiting

Hackensack, New Jersey, United States, 07601

Equity Medical LLC

Recruiting

The Bronx, New York, United States, 10455

Optima Research - Boardman

Recruiting

Boardman, Ohio, United States, 44512

Apex Clinical Research Center, LLC

Recruiting

Canton, Ohio, United States, 44718

Apex Clinical Research Center, LLC

Recruiting

Mayfield Heights, Ohio, United States, 44124

UPMC Department of Dermatology

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Medical Univ of SC Department of Dermatology

Recruiting

Charleston, South Carolina, United States, 29425

DelRicht Research

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

DelRicht Research

Recruiting

Smyrna, Tennessee, United States, 37167

DelRicht Research

Recruiting

Prosper, Texas, United States, 75078

Stryde Research-Epiphany Dermatology

Recruiting

Southlake, Texas, United States, 76092

Dermatology Specialists of Spokane

Recruiting

Spokane, Washington, United States, 99202

York Dermatology Clinical and Research Centre

Recruiting

Richmond Hill, Ontario, Canada, L4B 1L1

North York Research Inc.

Recruiting

Toronto, Ontario, Canada, M2N 3A6

More Information

Sponsor

Bluefin Biomedicine, Inc.

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

Hidradenitis Suppurativa
acne inversa

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bluefin Biomedicine, Inc. on 2026-05-29.