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BFB759 for 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)

Phase 2 Interventional Bluefin Biomedicine, Inc. · NCT07105488

This trial tests whether the medicine BFB759 can help adults 18–75 with moderate to severe atopic dermatitis that has not been controlled by topical treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment225 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBluefin Biomedicine, Inc. Industry-sponsored
Locations55 sites (Phoenix, Arizona and 54 other locations)
Trial IDNCT07105488 on ClinicalTrials.gov

What this trial studies

This is a double-blind, placebo-controlled Phase 2 trial comparing BFB759 with placebo over a participation period of about 36 to 40 weeks. Adults with atopic dermatitis for at least one year and moderate to severe disease that is not adequately controlled by topical therapies are eligible. Participants will attend regular clinic visits, follow protocol restrictions on certain medications, and be monitored for changes in skin symptoms and side effects. People with certain infections, immune conditions, recent conflicting medications, or who are pregnant or breastfeeding are excluded.

Who should consider this trial

Good fit: Adults aged 18 to 75 with a physician diagnosis of atopic dermatitis for at least one year and moderate to severe disease not adequately controlled by topical treatments, who can attend regular visits and follow study rules, are ideal candidates.

Not a fit: People with mild eczema, active infections or other excluded immune conditions, recent use of interfering medications, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, BFB759 could provide a new systemic treatment option that reduces symptoms and flare-ups for adults with moderate to severe atopic dermatitis.

How similar studies have performed: While other systemic and biologic therapies for moderate to severe atopic dermatitis have shown clinical benefit, BFB759 is a novel agent now being tested in a Phase 2 trial and its effects are not yet established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisEczema
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.