A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis

Purpose

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.

Condition

  • Atopic Dermatitis (AD)

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel-arm, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active - high dose 		BFB759 high dose Day 1 followed by BFB759 every 2 weeks (Q2W) starting at Week 2 through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive)
  • Biological: 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 atopic dermatitis
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 two groups (Cross-1 or Cross-2) to receive BFB759 intervention. - Cross-1 will receive BFB759 at Week 16, and then BFB759 Q2W at Week 18 through Week 30 (inclusive). - Cross-2 will receive BFB759 at Week 16, and then BFB759 Q2W at Week 18 through Week 30 (inclusive).
  • Biological: 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 atopic dermatitis
  • Drug: Placebo
    Placebo for BFB759
Experimental
Active - low dose 		BFB759 low dose on Day 1 followed by BFB759 every 2 weeks (Q2W) starting at Week 2 through Week 14 (inclusive), which is followed by placebo Q2W at Weeks 16 through 30 (inclusive)
  • Biological: 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 atopic dermatitis

Recruiting Locations

Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute
Phoenix, Arizona 85008

Skin Cancer and Dermatology Institute
Phoenix, Arizona 85008

T. Joseph Raoof Md, Inc
Encino, California 91436

Marvel Clinical Research
Huntington Beach, California 92647

Antelope Valley Clinical Trials
Lancaster, California 93534

Probity Medical Research
Los Angeles, California 90017

NorCal Clinical Research
Rocklin, California 95765

Focus Clinical Research, LLC -S
West Hills, California 91307

Skin Care Research
Boca Raton, Florida 33486

Florida Academic Dermatology Center Res and Edu, LLC
Coral Gables, Florida 33134

Center for Skin Science and Innovation
Fort Lauderdale, Florida 33308

Gsi Clinical Research
Margate, Florida 33063

Ziaderm Research LLC
North Miami Beach, Florida 33162

Lenus Research & Medical Group, LLC
Sweetwater, Florida 33172

Clinical Trials Management - S
Tampa, Florida 33607

Conquest Research LLC
Winter Park, Florida 32789

Skin Cancer and Dermatology Institute
Douglasville, Georgia 30135

Southeast Research Specialists, LLC
Douglasville, Georgia 30135

The Indiana Clinical Trials Center
Plainfield, Indiana 46168

Clinical Trials Management - S
Covington, Louisiana 70433

Clinical Trials Management, LLC
Metairie, Louisiana 70006

MetroBoston Clinical Partners
Brighton, Massachusetts 02135

Oakland Hills Dermatology
Auburn Hills, Michigan 48326

MI Skin Innovations
Northville, Michigan 48167

Medisearch, LLC
Saint Joseph, Missouri 64506

Elias Research Associates
Missoula, Montana 59808

JDR Dermatology Research
Las Vegas, Nevada 89145

Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute
Reno, Nevada 89509

Skin Cancer and Dermatology Institute
Reno, Nevada 89509

Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute
Sparks, Nevada 89436

Skin Cancer and Dermatology Institute
Sparks, Nevada 89436

Schweiger Dermatology, PC R.D.
Hackensack, New Jersey 07601

Bobby Buka, MD (The Dermatology Specialist)
New York, New York 10012

Bobby Buka, MD
New York, New York 10012

Equity Medical, LLC
The Bronx, New York 10455

Vitality Clinical Trials LLC
Woodbury, New York 11797

DJL Clinical Research
Charlotte, North Carolina 28277

Optima Research-Boardman
Boardman, Ohio 44512

Apex Clinical Research Center, LLC
Canton, Ohio 44718

Apex Clinical Research Center, LLC
Mayfield Heights, Ohio 44124

UPMC
Pittsburgh, Pennsylvania 15213

International Clinical Research - Tennesee, LLC
Murfreesboro, Tennessee 37130

Dermatology Treatment & Research Center
Dallas, Texas 75230

Stride Clinical Research
Missouri City, Texas 77459

Progressive Clinical Research
San Antonio, Texas 78213

Stryde Research-Epiphany Dermatology
Southlake, Texas 76092

Virginia Dermatology & Skin Cancer Center
Norfolk, Virginia 23502

DBA Dermatology of Seattle & Bellevue -S
Burien, Washington 98618

More Details

Status
Recruiting
Sponsor
Bluefin Biomedicine, Inc.

Study Contact

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