Status:
WITHDRAWN
A Study of Topical BX005-A in Subjects With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
BiomX, Inc.
Collaborating Sponsors:
Maruho Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- Topical antimicrobials and antiseptic cleansers
- Use of antibacterial soaps or topical sodium hypochlorite-based products
- Current emollient use (need to convert to study emollient 7 days prior to Day 1)
- Currently being treated with biologic agents; exception: may be enrolled if dupilumab was discontinued at least 12 weeks prior to Day 1, or if other biologics were discontinued at least 5 half-lives prior to Day 1.
- Female subjects who are pregnant, breastfeeding, or planning a pregnancy, or are of childbearing potential and not using an effective and allowed form of contraception.
- Enrolled in another investigational study 30 days prior to Screening or 90 days prior to Screening if investigational agent was a phage product.
- Other medical and/or psychiatric conditions which makes the subject inappropriate for study participation, increases likelihood that the subject will not be able to comply with study therapy or procedures and/or which places the subject at undue risk
- Active abuse of alcohol and/or illicit drugs or a history of such abuse that would make it difficult for the subject to comply with study and/or place subject at undue risk
- Known infection with human immunodeficiency virus (HIV) or other immunodeficiency disorder.
- Current or prior history of a malignant neoplasm other than previously treated non-melanoma skin cancer
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05240300
Start Date
May 1 2022
End Date
June 1 2023
Last Update
August 3 2025
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