Atopic DermatitisPhase 1/2NCT05240300
A Study of Topical BX005-A in Subjects With Moderate to Severe Atopic Dermatitis
A Phase 1/2 study testing BX005-A in people with Atopic Dermatitis, run by BiomX, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- BX005-A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
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- 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
About this study
Official title: 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
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).
Read the 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
- Being tested
- BX005-A, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BX005-ABiological
phage gel
PlaceboOther
vehicle gel
| Study group | Role | What they receive |
|---|---|---|
| BX005-A | Experimental | twice daily topical application x 8 weeks Receives: Biological: BX005-A |
| Vehicle | Placebo comparator | twice daily topical application x 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
- aureus CFU in target AD skin lesion
Measured: 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
- aureus qPCR in target AD skin lesion
Measured: 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
Eczema Area and Severity Index of all lesional skin areas (range 0-72); higher score indicates worse atopic dermatitis
Measured: 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
vIGA-AD
Measured: Day 1 through Day 71 (± 2 days)
Change from baseline in SCORing Atopic Dermatitis (SCORAD) index in BX005-A vs vehicle groups
SCORing Atopic Dermatitis index of all lesional skin areas (range 0-103); higher score indicates worse atopic dermatitis
Measured: Day 1 through Day 71 (± 2 days)
Change from baseline in SCORing Atopic Dermatitis (SCORAD) index of the target AD skin lesion in BX005-A vs vehicle groups
Local SCORing Atopic Dermatitis index (range 0-15); higher score indicates worse atopic dermatitis
Measured: Day 1 through Day 71 (± 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study startMay 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Study did not start enrollment due to business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiomX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maruho Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Urania Rappo, MD, Study director, BiomX, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240300
- Sponsor's protocol ID
- BMX-05-001
- Status last verified
- Jul 2025
- First submitted
- 23 Jan 2022
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05240300
- Acronym / sponsor ID
- BMX-05-001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not start enrollment due to business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiomX, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Maruho Co., Ltd.
- Study start
- May 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BX005-A | Experimental | Biological: BX005-Atwice daily topical application x 8 weeks |
| Vehicle | Placebo comparator | Other: Placebotwice daily topical application x 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BX005-Aphage gel | Biological | BX005-A |
| Placebovehicle gel | Other | Vehicle |
Primary outcome
Safety and tolerability: adverse events (AEs)
Time frame: Through study completion Day 225 (+7 days)
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
Safety and tolerability: laboratory abnormalities
Time frame: Through study completion Day 225 (+7 days)
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
6 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 through Day 71 (± 2 days)
Change from baseline in SCORing Atopic Dermatitis (SCORAD) index in BX005-A vs vehicle groups
Time frame: Day 1 through Day 71 (± 2 days)
Change from baseline in SCORing Atopic Dermatitis (SCORAD) index of the target AD skin lesion in BX005-A vs vehicle groups
Time frame: Day 1 through Day 71 (± 2 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urania Rappo, MD study director
BiomX, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BX005-A in people with Atopic Dermatitis, run by BiomX, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: adverse events (AEs) (time frame: Through study completion Day 225 (+7 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.