NCT05240300

A Study of Topical BX005-A in Subjects With Moderate to Severe Atopic Dermatitis

A Phase 1b/2a, Double-blind (Sponsor Open), Randomized, Vehicle-controlled Study of Topically Administered BX005-A in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BiomX, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of study BMX-05-001 is to evaluate the safety, tolerability, efficacy, and pharmacodynamics of BX005-A compared to vehicle administered topically in adult subjects with moderate to severe atopic dermatitis (AD).

Detailed description

BMX-05-001 is a double-blind (Sponsor open), randomized, vehicle-controlled, first-in-human, Phase 1b/2a study to evaluate the safety, tolerability, efficacy, and pharmacodynamics of BX005-A compared to vehicle administered topically twice daily for 8 weeks to lesional areas in adult subjects with moderate to severe atopic dermatitis (AD).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	BX005-A	phage gel
OTHER	Placebo	vehicle gel

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-02-15
• Last updated: 2025-08-03

Regulatory

• FDA-regulated drug study