Health TrialsbyHealthPanel

A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis

ConditionAtopic Dermatitis (AD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBluefin Biomedicine, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Have certain infections or other immune conditions.

Recently used medications that could interfere with the study.

Are pregnant or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BFB759

    Biological/Vaccine

    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

Treatment groups

225 Participants
are divided into 3 treatment groups
Group A: Active - high doseExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions
Group C: Active - low doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bluefin Biomedicine, Inc.

Lead sponsor

Source ClinicalTrials.gov
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