EczemaPhase 1NCT03775434
A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis
A Phase 1 study testing Experimental: B244 in people with Eczema and Atopic Dermatitis, run by AOBiome LLC at 6 sites in United States.
Trial summary
An open-label, multicenter, Phase Ib study of B244 delivered as a topical spray to assess safety in pediatric subjects aged 2 to 17 years with atopic dermatitis Condition or disease Intervention/treatment Phase Atopic Dermatitis (Eczema) Biological: B244 Phase 1b Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Eczema, Atopic Dermatitis
- What is being tested?
- Experimental: B244
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Dec 2018to 10 Jun 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects are eligible to be included in the study only if all of the following criteria apply:
- Male and female subjects 2 to 17 years of age, inclusive.
- Confirmed diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria.
- A minimum of 10% but no more than 60% of the subjects' body surface area (see Appendix 6 for guidance) is affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, and excoriation; with the excoriation serving as the physical examination correlate of pruritus).
- A vIGA-AD scale of 2 or 3 at Screening and Baseline.
- Subject, or the parent or guardian, to provide written informed consent and authorization for protected health information disclosure.
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- Subjects must be generally in good health based on Investigator's assessment (other than atopic dermatitis).
- Normal vital signs, or with no clinically significant vital signs that in the opinion of the Investigator, would place the subject at increased risk or would confound the objectives of the study.
- Females must not be pregnant, as confirmed by negative urine pregnancy testing. Female subjects aged ≥11 years old, or female patients <11 years old who have started menstruating, will have urinary pregnancy test performed at Screening and prior to the first dose with negative results in order to participate in the study. Females must either practice abstinence from heterosexual contact or use one of the highly effective contraceptive options described in the Appendix 5.
- Male subjects of reproductive potential, must be willing to practice effective contraception during the study while receiving study treatment from Day 1 and for 7 days after the last study visit (Day 28).
- Ability to comprehend and comply with study procedures.
- Agree to commit to participate in the current protocol.
- Provide written informed consent prior to any study procedure being performed.
Who cannot join
- Subjects are excluded from the study if any of the following criteria apply:
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- Clinically significant physical or mental disorder which, in the opinion of the Investigator, would place the subject at increased risk or would confound the objectives of the study.
- Subjects with atopic dermatitis on the face only.
- Active cutaneous bacterial, viral or fungal infection in any treatment area at Baseline (eg, clinically infected atopic dermatitis).
- History or presence of immunological deficiencies or diseases, organ transplant, human immunodeficiency virus (HIV), diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant renal disease severe hepatic disorders, or other severe uncontrolled conditions (eg, drug or alcohol abuse), that are significant and/or that may pose a health risk to the subject in the study or may have an impact on the study assessments.
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- Unstable atopic dermatitis or a consistent requirement for high-potency corticosteroids (class I-III steroids).
- Active systemic or localized infection (including infected AD).
- Subjects unable to comply with the excluded medication/therapy restriction
- Known hypersensitivity to the study treatment.
- Known to have hepatitis B, hepatitis C or HIV I or II tests. Details will be recorded in medical history, a blood sample will not be collected for confirmation.
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the study.
- Any skin condition which in the Investigator's opinion may interfere with the evaluation of atopic dermatitis.
- Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than 5 times the drug's half-life, whichever is longer.
- Use of any biologic within a period of 5 times its half-life.
- Children or relatives of the Sponsor, clinical research organization, or the Study Site personnel are excluded from participating in the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dermatology Trial Associates
Bryant, Arkansas, 72022
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
L.A. Universal Research Center, Inc.
Los Angeles, California, 90057
Virginia Clinical Research, INC
Norfolk, Virginia, 23502
Skin Specialists, PC
Omaha, Nebraska, 68144
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
About this study
Official title: An Open-label, Multicenter, Phase Ib Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects Aged 2 to 17 Years With Atopic Dermatitis
An open-label, multicenter, Phase Ib study of B244 delivered as a topical spray to assess safety in pediatric subjects aged 2 to 17 years with atopic dermatitis
Condition or disease Intervention/treatment Phase Atopic Dermatitis (Eczema) Biological: B244 Phase 1b
Read the detailed description
This is a Phase 1b, open-label, single arm, multiple site study assessing twice daily B244 application for 28 days in pediatric subjects with mild to moderate atopic dermatitis.
Number of Subjects:
The study will enroll 36 subjects in 3 cohorts of 12 subjects:
- Cohort 1: subjects aged 2 to 5 years.
- Cohort 2: subjects aged 6 to 11 years.
- Cohort 3, subjects aged 12 to 17 years.
At Screening and Baseline, all subjects must have confirmed diagnosis of atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% but no more than 60% body surface area and a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scale of 2 or 3.
The duration of the study will be approximately 7 weeks. Subjects will attend for a Screening visit between Days -21 and -14. If all eligibility criteria and none of the exclusion criteria are met, subjects will be enrolled into the study and will be required to undergo a 14 day washout period (Days-14 to -1). Subjects will attend the study center on Day 1 and the Baseline assessments will be performed before application of the first dose.
On confirmation of continued eligibility the subject and parent or guardian of the subject will be coached on how to apply medication, depending on the affected areas. They will be instructed to apply B244 twice daily (approximately 12 hours apart) for 28 days.
The first dose will be applied in the clinic under the supervision of clinical staff. Details of dose administration will be recorded in the study diary provided. The subjects with their parent or guardian will return to the study center on Days 7, 14, and 21 for completion of study assessments.
There will be a final study visit on Day 28, this will be defined as the end of the study for the subjects. A time window of ±2 day will be permitted for these 4 visits. There will not be a period of confinement in the study center all visits will be outpatient visits. Safety monitoring will include review of TEAEs, vital signs and physical examination. Efficacy will be assessed using EASI, vIGA-AD scale, POEM and ItchMan scores.
- Conditions
- Eczema, Atopic Dermatitis
- Being tested
- Experimental: B244
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: B244Drug
B244 suspension in 30ml/bottle
| Study group | Role | What they receive |
|---|---|---|
| B244 | Experimental | B244 suspension in 30ml/bottle Receives: Drug: Experimental: B244 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)as Assessed by CTCAE v4.0
Safety and tolerability endpoints will consist of all adverse events reporting from Baseline to Day 28.
Measured: Baseline to Day 28
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
A physical exam will be conducted by a physician assessing systems (General appearance, Dermatological, Musculoskeletal, Thyroid, HEENT [Head, eyes, ears, nose, throat], Lymphatic, Respiratory, Gastrointestinal, Cardiovascular, Neurological, Extremities, and other). Clinical significance of the physical exam will be determined at investigator's discretion. Results for each system were assessed as Normal, Abnormal CS (clinically significant), or Abnormal NCS (not clinically significant) and shift was analyzed from Baseline to Day 28.
Measured: Baseline to Day 28
Mean Change in Blood Pressure From Baseline at Day 28
Blood pressure will be obtained (mmHg). Clinical significance of blood pressure will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Measured: Baseline to Day 28
Mean Change in Pulse Rate From Baseline at Day 28
Pulse rate (beats per minute [bpm]) will be obtained. Clinical significance of pulse rate will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Measured: Baseline to Day 28
Mean Change in Body Temperature From Baseline at Day 28
Body temperature (°C) will be obtained. Clinical significance of body temperature will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start7 Dec 2018
- Primary completion18 May 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EczemaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive active product
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOBiome LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Responsible party
- Sponsor
- Investigators
- Judith Ng-Cashin, MD, Study director, Chief Medical OfficerSpiros Jamas, ScD, Study director, AOBiome Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775434
- Sponsor's protocol ID
- ADB244-002
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2018
- Last updated
- 5 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase Ib Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects Aged 2 to 17 Years With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03775434
- Acronym / sponsor ID
- ADB244-002
- Conditions
- Eczema, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AOBiome LLCIndustry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 18 May 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, multicenter, Phase Ib study of B244 delivered as a topical spray to assess safety in pediatric subjects aged 2 to 17 years with atopic dermatitis
Condition or disease Intervention/treatment Phase Atopic Dermatitis (Eczema) Biological: B244 Phase 1b
Detailed description
This is a Phase 1b, open-label, single arm, multiple site study assessing twice daily B244 application for 28 days in pediatric subjects with mild to moderate atopic dermatitis.
Number of Subjects:
The study will enroll 36 subjects in 3 cohorts of 12 subjects:
- Cohort 1: subjects aged 2 to 5 years.
- Cohort 2: subjects aged 6 to 11 years.
- Cohort 3, subjects aged 12 to 17 years.
At Screening and Baseline, all subjects must have confirmed diagnosis of atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% but no more than 60% body surface area and a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scale of 2 or 3.
The duration of the study will be approximately 7 weeks. Subjects will attend for a Screening visit between Days -21 and -14. If all eligibility criteria and none of the exclusion criteria are met, subjects will be enrolled into the study and will be required to undergo a 14 day washout period (Days-14 to -1). Subjects will attend the study center on Day 1 and the Baseline assessments will be performed before application of the first dose.
On confirmation of continued eligibility the subject and parent or guardian of the subject will be coached on how to apply medication, depending on the affected areas. They will be instructed to apply B244 twice daily (approximately 12 hours apart) for 28 days.
The first dose will be applied in the clinic under the supervision of clinical staff. Details of dose administration will be recorded in the study diary provided. The subjects with their parent or guardian will return to the study center on Days 7, 14, and 21 for completion of study assessments.
There will be a final study visit on Day 28, this will be defined as the end of the study for the subjects. A time window of ±2 day will be permitted for these 4 visits. There will not be a period of confinement in the study center all visits will be outpatient visits. Safety monitoring will include review of TEAEs, vital signs and physical examination. Efficacy will be assessed using EASI, vIGA-AD scale, POEM and ItchMan scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive active product
| Arm | Type | Receives |
|---|---|---|
| B244 | Experimental | Drug: Experimental: B244B244 suspension in 30ml/bottle |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Subjects are eligible to be included in the study only if all of the following criteria apply:
Key exclusion criteria (16 listed)
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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 |
|---|---|---|
| Experimental: B244B244 suspension in 30ml/bottle | Drug | B244 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)as Assessed by CTCAE v4.0
Time frame: Baseline to Day 28
Safety and tolerability endpoints will consist of all adverse events reporting from Baseline to Day 28.
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
Time frame: Baseline to Day 28
A physical exam will be conducted by a physician assessing systems (General appearance, Dermatological, Musculoskeletal, Thyroid, HEENT [Head, eyes, ears, nose, throat], Lymphatic, Respiratory, Gastrointestinal, Cardiovascular, Neurological, Extremities, and other). Clinical significance of the physical exam will be determined at investigator's discretion. Results for each system were assessed as Normal, Abnormal CS (clinically significant), or Abnormal NCS (not clinically significant) and shift was analyzed from Baseline to Day 28.
Mean Change in Blood Pressure From Baseline at Day 28
Time frame: Baseline to Day 28
Blood pressure will be obtained (mmHg). Clinical significance of blood pressure will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Mean Change in Pulse Rate From Baseline at Day 28
Time frame: Baseline to Day 28
Pulse rate (beats per minute [bpm]) will be obtained. Clinical significance of pulse rate will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Mean Change in Body Temperature From Baseline at Day 28
Time frame: Baseline to Day 28
Body temperature (°C) will be obtained. Clinical significance of body temperature will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Judith Ng-Cashin, MD study director
Chief Medical Officer
Spiros Jamas, ScD study director
AOBiome Therapeutics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experimental: B244 in people with Eczema and Atopic Dermatitis, run by AOBiome LLC at 6 sites in United States.
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 13 inclusion and 16 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: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs)as Assessed by CTCAE v4.0 (time frame: Baseline to Day 28). The study lists 5 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 5 Aug 2024.