A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis

Phase 2Active Not RecruitingNCT07105488

Bluefin Biomedicine, Inc.225 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

225

Conditions

Atopic Dermatitis (AD)

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (88)

Outcomes

Primary Outcomes

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.

Time frame: week 16 and week 32

Secondary Outcomes

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).

Time frame: Week 16

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).

Time frame: Week 32

Safety and tolerability

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

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

Data from ClinicalTrials.gov

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