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Atopic Dermatitis (AD)Phase 2COMPASS 2-ADNCT07105488

A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis

A Phase 2 study testing BFB759 in people with Atopic Dermatitis (AD), run by Bluefin Biomedicine, Inc. at 88 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis (AD)
What is being tested?
BFB759
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
225 participants
Where
88 sitesin 7 countries
Study dates
15 Jul 2025to 31 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

88 sites in 7 countries.

88 sites in 7 countries

United States48 sites

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326

  • Optima Research-Boardman

    Boardman, Ohio, 44512

  • Skin Care Research

    Boca Raton, Florida, 33486

  • MetroBoston Clinical Partners

    Brighton, Massachusetts, 02135

  • DBA Dermatology of Seattle & Bellevue -S

    Burien, Washington, 98618

  • Apex Clinical Research Center, LLC

    Canton, Ohio, 44718

  • DJL Clinical Research

    Charlotte, North Carolina, 28277

  • Florida Academic Dermatology Center Res and Edu, LLC

    Coral Gables, Florida, 33134

  • Clinical Trials Management - S

    Covington, Louisiana, 70433

  • Dermatology Treatment & Research Center

    Dallas, Texas, 75230

  • Skin Cancer and Dermatology Institute

    Douglasville, Georgia, 30135

  • Southeast Research Specialists, LLC

    Douglasville, Georgia, 30135

  • T. Joseph Raoof Md, Inc

    Encino, California, 91436

  • Center for Skin Science and Innovation

    Fort Lauderdale, Florida, 33308

  • Schweiger Dermatology, PC R.D.

    Hackensack, New Jersey, 07601

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • JDR Dermatology Research

    Las Vegas, Nevada, 89145

  • Probity Medical Research

    Los Angeles, California, 90017

  • Gsi Clinical Research

    Margate, Florida, 33063

  • Apex Clinical Research Center, LLC

    Mayfield Heights, Ohio, 44124

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Elias Research Associates

    Missoula, Montana, 59808

  • Stride Clinical Research

    Missouri City, Texas, 77459

  • International Clinical Research - Tennesee, LLC

    Murfreesboro, Tennessee, 37130

  • Bobby Buka, MD (The Dermatology Specialist)

    New York, New York, 10012

  • Bobby Buka, MD

    New York, New York, 10012

  • Virginia Dermatology & Skin Cancer Center

    Norfolk, Virginia, 23502

  • Ziaderm Research LLC

    North Miami Beach, Florida, 33162

  • MI Skin Innovations

    Northville, Michigan, 48167

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

    Phoenix, Arizona, 85008

  • Skin Cancer and Dermatology Institute

    Phoenix, Arizona, 85008

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

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

    Reno, Nevada, 89509

  • Skin Cancer and Dermatology Institute

    Reno, Nevada, 89509

  • NorCal Clinical Research

    Rocklin, California, 95765

  • Medisearch, LLC

    Saint Joseph, Missouri, 64506

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Stryde Research-Epiphany Dermatology

    Southlake, Texas, 76092

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

    Sparks, Nevada, 89436

  • Skin Cancer and Dermatology Institute

    Sparks, Nevada, 89436

  • Lenus Research & Medical Group, LLC

    Sweetwater, Florida, 33172

  • Clinical Trials Management - S

    Tampa, Florida, 33607

  • Equity Medical, LLC

    The Bronx, New York, 10455

  • Focus Clinical Research, LLC -S

    West Hills, California, 91307

  • Conquest Research LLC

    Winter Park, Florida, 32789

  • Vitality Clinical Trials LLC

    Woodbury, New York, 11797

Other trials in United States

Poland16 sites

  • ClinicMed Daniluk, Nowak

    Bialystok

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz

  • DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gębska

    Chorzów

  • PI House

    Gdansk

  • Synexus Polska Sp. z o.o.

    Gdansk

  • Mazowieckie Centrum Badan Klinicznych

    Grodzisk Mazowiecki

  • Centrum Badan Klinicznych JCI

    Krakow

  • Klinika Badawcza Centrum Badan Klinicznych

    Malbork

  • Klinika Zdybski - Dermedic

    Ostrowiec Świętokrzyski

  • EMC Instytut Medyczny SA - Prywatna Lecznica Certus Szpital i Ambulatorium

    Poznan

  • Centrum Zdrowia Dziecka i Rodziny im. Jana Pawla II w Sosnowcu, Osrodek Badan Klinicznych

    Sosnowiec

  • MICS Centrum Medyczne

    Torun

  • Manufaktura Urody

    Warsaw

  • Prywatna Praktyka Lekarska Ewa Ring

    Warsaw

  • Therapia Nova Sp z o.o

    Warsaw

  • UW Wroclaw

    Wroclaw

Other trials in Poland

Canada7 sites

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1

  • Vida Clinical Research

    Edmonton, Alberta, T6H 4J8

  • Probity Medical Research

    Mississauga, Ontario, L4Y 4C5

  • Centre de Recherche Saint-Louis (Montreal)

    Montreal, Quebec, H1Y 3L1

  • Probity Medical Research

    Richmond Hill, Ontario, L4B 1A5

  • York Dermatology

    Richmond Hill, Ontario, L4B 3L4

  • Saskatoon Dermatology Centre

    Saskatoon, Saskatchewan, S7T 0G3

Other trials in Canada

Germany5 sites

  • Fachklinik Bad Bentheim - Dermatology Hospital Bad Bentheim

    Bad Bentheim

  • CRS Clinical Research Services Berlin GmbH

    Berlin

  • Universitaetsmedizin Goettingen

    Göttingen

  • University Hospital Heidelberg Occupational Dermatology Department of Dermatology

    Heidelberg

  • Universitaetsklinikum Muenster (UKM) - Klinik fuer Hautkrankheiten

    Münster

Other trials in Germany

Spain5 sites

  • Hospital General Universitario de Alicante - Instituto de Investigacion Sanitaria y Biomedica de Alicante (ISABIAL) - Fundacion FISABIO

    Alicante

  • Hospital Universitario Reina Sofia

    Córdoba

  • Hospital Asil de Granollers

    Granollers

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Ramón y Cajal and Grupo Pedro Jaén

    Madrid

Other trials in Spain

Czechia4 sites

  • CCR Ostrava

    Ostrava

  • Pratia Pardubice

    Pardubice

  • Clintrial s.r.o.

    Prague

  • Private Dermatovenerology Practice

    Prague

Other trials in Czechia

Bulgaria3 sites

  • Medical Center Medconsult Burgas EOOD

    Burgas

  • Medical Centre Asklepii OOD

    Dupnitsa

  • Medconsult Lovech

    Lovech

Other trials in Bulgaria

About this study

Official title: 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)

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.

Being tested
BFB759, Placebo
Keywords
Atopic Dermatitis, Eczema
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BFB759Biological

    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

  • PlaceboDrug

    Placebo for BFB759

Study groups in NCT07105488
Study groupRoleWhat they receive
Active - high doseExperimentalBFB759 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)
Receives: Biological: BFB759
PlaceboPlacebo 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).
Receives: Biological: BFB759; Drug: Placebo
Active - low doseExperimentalBFB759 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)
Receives: Biological: BFB759

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: week 16 and week 32

Secondary outcomes (3)

  1. How well the treatment works at Week 16

    • How many participants had at least a 50%, 75%, or 90% improvement in their eczema signs.
    • How much the severity and size of eczema-affected areas improved.
    • Whether participants felt less itchy.
    • How many participants had a drop of 4 or more points in their itch score (especially for those who started with a higher itch level).

    Measured: Week 16

  2. How well the treatment works at week 32

    • How much eczema signs changed from Week 16.
    • How many participants had a 50%, 75%, or 90% improvement since Week 16.
    • Changes in eczema severity and itch compared to Week 16.
    • How many people had a 4-point drop in their itch score (again, only among those who had higher itch scores at Week 16).

    Measured: Week 32

  3. Safety and tolerability

    • record side effects and severity
    • record how well participants tolerate the treatment over time

    Measured: 21 months (about 22 visits during the course of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start15 Jul 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel-arm, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07105488
Sponsor's protocol ID
CL-BFB759-002
Acronym
COMPASS 2-AD
Status last verified
Jul 2026
First submitted
21 Jul 2025
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BFB759 in people with Atopic Dermatitis (AD), run by Bluefin Biomedicine, Inc. at 88 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Poland, Canada, Germany, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of BFB759 in AD (time frame: week 16 and week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07105488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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