RecruitingPhase 2NCT07105488

A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis

A Phase 2, Parallel-arm, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of BFB759 in Patients With Atopic Dermatitis (COMPASS 2-AD)


Sponsor

Bluefin Biomedicine, Inc.

Enrollment

225 participants

Start Date

Jul 15, 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 (18-75) with a diagnosis of atopic dermatitis for at least one year.
  • Have moderate to severe disease not adequately controlled by topical treatments.
  • 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 atopic dermatitis

DRUGPlacebo

Placebo for BFB759


Locations(55)

Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute

Phoenix, Arizona, United States

Skin Cancer and Dermatology Institute

Phoenix, Arizona, United States

T. Joseph Raoof Md, Inc

Encino, California, United States

Marvel Clinical Research

Huntington Beach, California, United States

Antelope Valley Clinical Trials

Lancaster, California, United States

Probity Medical Research

Los Angeles, California, United States

NorCal Clinical Research

Rocklin, California, United States

Focus Clinical Research, LLC -S

West Hills, California, United States

Skin Care Research

Boca Raton, Florida, United States

Florida Academic Dermatology Center Res and Edu, LLC

Coral Gables, Florida, United States

Center for Skin Science and Innovation

Fort Lauderdale, Florida, United States

Gsi Clinical Research

Margate, Florida, United States

Ziaderm Research LLC

North Miami Beach, Florida, United States

Lenus Research & Medical Group, LLC

Sweetwater, Florida, United States

Clinical Trials Management - S

Tampa, Florida, United States

Conquest Research LLC

Winter Park, Florida, United States

Skin Cancer and Dermatology Institute

Douglasville, Georgia, United States

Southeast Research Specialists, LLC

Douglasville, Georgia, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Clinical Trials Management - S

Covington, Louisiana, United States

Clinical Trials Management, LLC

Metairie, Louisiana, United States

MetroBoston Clinical Partners

Brighton, Massachusetts, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

MI Skin Innovations

Northville, Michigan, United States

Medisearch, LLC

Saint Joseph, Missouri, United States

Elias Research Associates

Missoula, Montana, United States

JDR Dermatology Research

Las Vegas, Nevada, United States

Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute

Reno, Nevada, United States

Skin Cancer and Dermatology Institute

Reno, Nevada, United States

Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute

Sparks, Nevada, United States

Skin Cancer and Dermatology Institute

Sparks, Nevada, United States

Schweiger Dermatology, PC R.D.

Hackensack, New Jersey, United States

Bobby Buka, MD (The Dermatology Specialist)

New York, New York, United States

Bobby Buka, MD

New York, New York, United States

Equity Medical, LLC

The Bronx, New York, United States

Vitality Clinical Trials LLC

Woodbury, New York, United States

DJL Clinical Research

Charlotte, North Carolina, 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

Pittsburgh, Pennsylvania, United States

International Clinical Research - Tennesee, LLC

Murfreesboro, Tennessee, United States

Dermatology Treatment & Research Center

Dallas, Texas, United States

Stride Clinical Research

Missouri City, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Stryde Research-Epiphany Dermatology

Southlake, Texas, United States

Virginia Dermatology & Skin Cancer Center

Norfolk, Virginia, United States

DBA Dermatology of Seattle & Bellevue -S

Burien, Washington, United States

Dermatology Research Institute

Calgary, Alberta, Canada

Vida Clinical Research

Edmonton, Alberta, Canada

Probity Medical Research

Mississauga, Ontario, Canada

Probity Medical Research

Richmond Hill, Ontario, Canada

York Dermatology

Richmond Hill, Ontario, Canada

Centre de Recherche Saint-Louis (Montreal)

Montreal, Quebec, Canada

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

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NCT07105488


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