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Active, Not Recruiting

NCT Number: NCT07105488

A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Center Medconsult Burgas EOOD, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BFB759

Biological

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

Drug

Placebo for BFB759

Primary outcomes

  1. Efficacy of BFB759 in AD

    Time frame: week 16 and week 32

    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.

Secondary outcomes

  1. How well the treatment works at Week 16

    Time frame: 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).

  2. How well the treatment works at week 32

    Time frame: 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).

  3. Safety and tolerability

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

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

Sponsors and collaborators

Lead sponsor

Bluefin Biomedicine, Inc.

Industry

Registry information

Official study 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)

Acronym: COMPASS 2-AD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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