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

NCT05240300 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: BMX-05-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability: adverse events (AEs)

  The proportion of subjects with any AE, treatment-emergent AE (TEAE), serious adverse event, TEAE leading to study drug discontinuation, TEAE leading to study discontinuation, or death

  Through study completion Day 225 (+7 days)

• Safety and tolerability: laboratory abnormalities

  The proportion of subjects with abnormalities in laboratory parameters, graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials

  Through study completion Day 225 (+7 days)

Secondary Outcomes (6)

• Change from baseline in log S. aureus density, measured by colony forming units (CFU)/cm2 in the target AD skin lesion in BX005-A vs vehicle groups

  Day 1 through Day 71 (± 2 days)

• Change from baseline in log S. aureus density, measured by quantitative PCR (qPCR)/cm2 in the target AD skin lesion in BX005-A vs vehicle groups

  Day 1 through Day 71 (± 2 days)

• % change from baseline in the Eczema Area and Severity Index (EASI) score in BX005-A vs vehicle groups

  Day 1 through Day 71 (± 2 days)

• Proportion of subjects who achieve a Validated Investigator Global Assessment AD (vIGA-AD) score of 0 or 1 with at least a 2-grade reduction from baseline in BX005-A vs vehicle groups

  Day 1 through Day 71 (± 2 days)

• Change from baseline in SCORing Atopic Dermatitis (SCORAD) index in BX005-A vs vehicle groups

  Day 1 through Day 71 (± 2 days)

Study Arms (2)

BX005-A

EXPERIMENTAL

twice daily topical application x 8 weeks

Biological: BX005-A

Vehicle

PLACEBO COMPARATOR

twice daily topical application x 8 weeks

Other: Placebo

Interventions

BX005-A BIOLOGICAL

phage gel

BX005-A

Placebo OTHER

vehicle gel

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years old
• Confirmed clinical diagnosis of active AD with at least a 6-month history and clinically stable AD for ≥ 1 month
• Clinical diagnosis of moderate or severe AD with a vIGA-AD score of ≥ 3 and a lesion vIGA-AD score ≥ 3 in the target AD skin lesion
• BSA with AD of 2%-30%, excluding scalp
• Colonized with S. aureus in at least one AD skin lesion
• Female subjects of non-childbearing potential must meet at least 1 of the following: postmenopausal status; documented hysterectomy and/or bilateral oophorectomy; or medically confirmed ovarian failure. All other female subjects (including those who have undergone tubal ligation) are of childbearing potential.
• Female subjects of childbearing potential who have a negative urine pregnancy test
• Effective contraceptive method for female subjects of childbearing potential and for male subjects
• Able to understand study procedures and attend all study visits
• Willing to refrain from use of all other systemic or topical agents for the treatment of AD or the prevention of complications of AD (e.g., secondary infection)

You may not qualify if:

• Active skin infection and/or systemic infection requiring systemic or topical antimicrobial agents and/or a skin drainage procedure, or a history of recurrent bacterial skin infections
• Other concurrent skin diseases which could interfere with the diagnosis and/or management of AD (e.g., psoriasis, contact dermatitis), or presence of open, chronic non-healing wounds in their treatable AD lesions
• Known hypersensitivity to study drug, its excipients, simethicone, and/or any emollient to be used in study
• Planned treatment with a prohibited medication during study, or received a prohibited medication within time frame noted below, prior to first dose of study drug:
• Must be discontinued at least 28 Days prior to Day 1:
• Systemic corticosteroids
• Systemic JAK inhibitors and immunosuppressive agents
• Nonbiologic investigational agent or device
• Total body phototherapy
• Must be discontinued at least 14 Days prior to Day 1:
• Systemic antimicrobials
• Probiotics and prebiotics
• Prescription skin barrier repair products
• Must be discontinued at least 7 Days prior to Day 1:
• Topical therapies for AD

Sponsors & Collaborators

• BiomX, Inc.: lead
• Maruho Co., Ltd.: collaborator

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Urania Rappo, MD

  BiomX, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 15, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share