Atopic Dermatitis (AD)
Conditions
Keywords
Atopic Dermatitis, Eczema
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.
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
Sponsors
Bluefin Biomedicine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel-arm, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of BFB759 in AD | 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
| Measure | Time frame | Description |
|---|---|---|
| How well the treatment works at Week 16 | 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). |
| How well the treatment works at week 32 | 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). |
| Safety and tolerability | 21 months (about 22 visits during the course of study) | * record side effects and severity * record how well participants tolerate the treatment over time |
Countries
Bulgaria, Canada, Czechia, Germany, Poland, Spain, United States
Outcome results
None listed