A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis
COMPASS 2-AD
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)
1 other identifier
interventional
225
7 countries
88
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2025
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2025
CompletedFirst Submitted
Initial submission to the registry
July 21, 2025
CompletedFirst Posted
Study publicly available on registry
August 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
July 30, 2026
July 1, 2026
1.6 years
July 21, 2025
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of BFB759 in AD
To evaluate the efficacy of BFB759 in adult male and female participants with AD as assessed by Eczema Area and Severity Index (EASI) score. Measure improvements in redness, swelling, scratching damage, and roughness.
week 16 and week 32
Secondary Outcomes (3)
How well the treatment works at Week 16
Week 16
How well the treatment works at week 32
Week 32
Safety and tolerability
21 months (about 22 visits during the course of study)
Study Arms (3)
Active - high dose
EXPERIMENTALBFB759 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)
Placebo
PLACEBO COMPARATORPlacebo 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).
Active - low dose
EXPERIMENTALBFB759 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute
Phoenix, Arizona, 85008, United States
Skin Cancer and Dermatology Institute
Phoenix, Arizona, 85008, United States
T. Joseph Raoof Md, Inc
Encino, California, 91436, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
Antelope Valley Clinical Trials
Lancaster, California, 93534, United States
Probity Medical Research
Los Angeles, California, 90017, United States
NorCal Clinical Research
Rocklin, California, 95765, United States
Focus Clinical Research, LLC -S
West Hills, California, 91307, United States
Skin Care Research
Boca Raton, Florida, 33486, United States
Florida Academic Dermatology Center Res and Edu, LLC
Coral Gables, Florida, 33134, United States
Center for Skin Science and Innovation
Fort Lauderdale, Florida, 33308, United States
Gsi Clinical Research
Margate, Florida, 33063, United States
Ziaderm Research LLC
North Miami Beach, Florida, 33162, United States
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172, United States
Clinical Trials Management - S
Tampa, Florida, 33607, United States
Conquest Research LLC
Winter Park, Florida, 32789, United States
Skin Cancer and Dermatology Institute
Douglasville, Georgia, 30135, United States
Southeast Research Specialists, LLC
Douglasville, Georgia, 30135, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Clinical Trials Management - S
Covington, Louisiana, 70433, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
MetroBoston Clinical Partners
Brighton, Massachusetts, 02135, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326, United States
MI Skin Innovations
Northville, Michigan, 48167, United States
Medisearch, LLC
Saint Joseph, Missouri, 64506, United States
Elias Research Associates
Missoula, Montana, 59808, United States
JDR Dermatology Research
Las Vegas, Nevada, 89145, United States
Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute
Reno, Nevada, 89509, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509, United States
Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology Institute
Sparks, Nevada, 89436, United States
Skin Cancer and Dermatology Institute
Sparks, Nevada, 89436, United States
Schweiger Dermatology, PC R.D.
Hackensack, New Jersey, 07601, United States
Bobby Buka, MD (The Dermatology Specialist)
New York, New York, 10012, United States
Bobby Buka, MD
New York, New York, 10012, United States
Equity Medical, LLC
The Bronx, New York, 10455, United States
Vitality Clinical Trials LLC
Woodbury, New York, 11797, United States
DJL Clinical Research
Charlotte, North Carolina, 28277, United States
Optima Research-Boardman
Boardman, Ohio, 44512, United States
Apex Clinical Research Center, LLC
Canton, Ohio, 44718, United States
Apex Clinical Research Center, LLC
Mayfield Heights, Ohio, 44124, United States
UPMC
Pittsburgh, Pennsylvania, 15213, United States
International Clinical Research - Tennesee, LLC
Murfreesboro, Tennessee, 37130, United States
Dermatology Treatment & Research Center
Dallas, Texas, 75230, United States
Stride Clinical Research
Missouri City, Texas, 77459, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Stryde Research-Epiphany Dermatology
Southlake, Texas, 76092, United States
Virginia Dermatology & Skin Cancer Center
Norfolk, Virginia, 23502, United States
DBA Dermatology of Seattle & Bellevue -S
Burien, Washington, 98618, United States
Medical Center Medconsult Burgas EOOD
Burgas, Bulgaria
Medical Centre Asklepii OOD
Dupnitsa, Bulgaria
Medconsult Lovech
Lovech, Bulgaria
Dermatology Research Institute
Calgary, Alberta, T2J 7E1, Canada
Vida Clinical Research
Edmonton, Alberta, T6H 4J8, Canada
Probity Medical Research
Mississauga, Ontario, L4Y 4C5, Canada
Probity Medical Research
Richmond Hill, Ontario, L4B 1A5, Canada
York Dermatology
Richmond Hill, Ontario, L4B 3L4, Canada
Centre de Recherche Saint-Louis (Montreal)
Montreal, Quebec, H1Y 3L1, Canada
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T 0G3, Canada
CCR Ostrava
Ostrava, Czechia
Pratia Pardubice
Pardubice, Czechia
Clintrial s.r.o.
Prague, Czechia
Private Dermatovenerology Practice
Prague, Czechia
Fachklinik Bad Bentheim - Dermatology Hospital Bad Bentheim
Bad Bentheim, Germany
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
Universitaetsmedizin Goettingen
Göttingen, Germany
University Hospital Heidelberg Occupational Dermatology Department of Dermatology
Heidelberg, Germany
Universitaetsklinikum Muenster (UKM) - Klinik fuer Hautkrankheiten
Münster, Germany
ClinicMed Daniluk, Nowak
Bialystok, Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Poland
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gębska
Chorzów, Poland
PI House
Gdansk, Poland
Synexus Polska Sp. z o.o.
Gdansk, Poland
Mazowieckie Centrum Badan Klinicznych
Grodzisk Mazowiecki, Poland
Centrum Badan Klinicznych JCI
Krakow, Poland
Klinika Badawcza Centrum Badan Klinicznych
Malbork, Poland
Klinika Zdybski - Dermedic
Ostrowiec Świętokrzyski, Poland
EMC Instytut Medyczny SA - Prywatna Lecznica Certus Szpital i Ambulatorium
Poznan, Poland
Centrum Zdrowia Dziecka i Rodziny im. Jana Pawla II w Sosnowcu, Osrodek Badan Klinicznych
Sosnowiec, Poland
MICS Centrum Medyczne
Torun, Poland
Manufaktura Urody
Warsaw, Poland
Prywatna Praktyka Lekarska Ewa Ring
Warsaw, Poland
Therapia Nova Sp z o.o
Warsaw, Poland
UW Wroclaw
Wroclaw, Poland
Hospital General Universitario de Alicante - Instituto de Investigacion Sanitaria y Biomedica de Alicante (ISABIAL) - Fundacion FISABIO
Alicante, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Asil de Granollers
Granollers, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Ramón y Cajal and Grupo Pedro Jaén
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2025
First Posted
August 6, 2025
Study Start
July 15, 2025
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share