RecruitingPhase 2Phase 3NCT07287644

A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

A Phase 2, Dose Ranging, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Patients With Moderate to Severe Hidradenitis Suppurativa


Sponsor

Bluefin Biomedicine, Inc.

Enrollment

210 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria3

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

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Interventions

BIOLOGICALBFB759

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.

OTHERPlacebo for BFB759

Placebo for BFB759


Locations(33)

Saguaro Dermatology

Phoenix, Arizona, United States

Encino Research Center

Encino, California, United States

Clinical Science Institute

Santa Monica, California, United States

Skin Care Research

Boca Raton, Florida, United States

Center for Skin Science and Innovation

Fort Lauderdale, Florida, United States

Ziaderm Research LLC

North Miami Beach, Florida, United States

Clinical Trials Management, LLC

Tampa, Florida, United States

DelRicht Research

Atlanta, Georgia, United States

Southeast Research Specialist LLC

Douglasville, Georgia, United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

DS Research of Kentucky

Louisville, Kentucky, United States

Martha Stewart

Mandeville, Louisiana, United States

Clinical Trials Management, LLC

Metairie, Louisiana, United States

DelRicht Research

New Orleans, Louisiana, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

MI Skin Innovations

Northville, Michigan, United States

DelRicht Research

Wildwood, Missouri, United States

JDR Dermatology Research LLC

Las Vegas, Nevada, United States

Skin Cancer and Dermatology Institute

Reno, Nevada, United States

Schweiger Dermatology, PC

Hackensack, New Jersey, United States

Equity Medical LLC

The Bronx, New York, United States

Optima Research - Boardman

Boardman, Ohio, United States

Apex Clinical Research Center, LLC

Canton, Ohio, United States

Apex Clinical Research Center, LLC

Mayfield Heights, Ohio, United States

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, United States

Medical Univ of SC Department of Dermatology

Charleston, South Carolina, United States

DelRicht Research

Mt. Pleasant, South Carolina, United States

DelRicht Research

Smyrna, Tennessee, United States

DelRicht Research

Prosper, Texas, United States

Stryde Research-Epiphany Dermatology

Southlake, Texas, United States

Dermatology Specialists of Spokane

Spokane, Washington, United States

York Dermatology Clinical and Research Centre

Richmond Hill, Ontario, Canada

North York Research Inc.

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT07287644


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