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)
Bluefin Biomedicine, Inc.
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- 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.
Interventions
- BiologicalBFB759
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
- DrugPlacebo
Placebo for BFB759
Locations (55)
- Mountain West Derm - Blackhart PLLC dba Skin Cancer and Dermatology InstitutePhoenix, Arizona
- Skin Cancer and Dermatology InstitutePhoenix, Arizona
- T. Joseph Raoof Md, IncEncino, California
- Marvel Clinical ResearchHuntington Beach, California
- Antelope Valley Clinical TrialsLancaster, California
- Probity Medical ResearchLos Angeles, California