Atopic Dermatitis EczemaPhase 2NCT03235024
Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis
A Phase 2 study testing B244 in people with Atopic Dermatitis Eczema, run by AOBiome LLC at 17 sites in United States.
Trial summary
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis Eczema
- What is being tested?
- B244
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 17 sitesUnited States
- Study dates
- 15 Jan 2018to 20 Mar 2019
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects ≥18 years of age
- In good general health as determined by a thorough medical history and physical examination, and vital signs
- Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of Hanifin and Rajka
- Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21
- A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus
- A minimum of 10% and not more than 30% of the subjects' BSA affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, excoriation, with the excoriation serving as the physical examination correlate of pruritus)
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- An IGA score of 2-3
- Patient has a history of AD for ≥12 months
- Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure
Who cannot join
- Pregnant and lactating women by urine pregnancy testing
- Subjects with any significant clinical abnormalities which may interfere with study participation
- Any skin condition which may interfere with evaluation of AD
- Atopic dermatitis only on the head or scalp
- Subjects with Atopic dermatitis on the face
- Unstable or actively infected atopic dermatitis
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- Patients suffering from pruritus from conditions other than AD
- Patients with chronic pruritus due to systemic disease
- Patients with conditions requiring inhaled steroids
- Have concurrent skin disease of such severity in the study area that it could interfere with the study evaluation
- Have active skin infections on the treatment area
- Have received or planning to receive topical corticosteroids, topical coal tar, topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy, oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics, glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents, systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within 2 weeks of Baseline visit.
- Current or recent history (≤3 months of systemic use of Otrexup™, Rasuvo®, Rheumatrex® and Trexall™ or its generic versions such as Methotrexate
- History of being seropositive for human immunodeficiency virus (HIV) at screening by laboratory testing at Screening
- History of being positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening by laboratory testing at Screening
- History of renal disease
- Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than five times the drug's half-life, whichever is longer
- Use of any biologic within a period of 5 times its half-life
- Use of vinegar or bleach baths within 2 weeks of starting the study
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
LoveLace Scientific Resources
Albuquerque, New Mexico, 87108
Central Research Associates
Birmingham, Alabama, 35205
DeNova Research dba Arano, LLC
Chicago, Illinois, 60611
Clarkston Skin Research
Clarkston, Michigan, 48349
Columbus Regional Research Institute
Columbus, Georgia, 31904
Encino Research Center
Encino, California, 91436
Neostart Corporation d.b.a AGA Clinical Trials
Hialeah, Florida, 33012
Clinical Neuroscience Solution, Inc
Jacksonville, Florida, 32256
FXM Research Corp.
Miami, Florida, 33175
FXM Research Miramar
Miramar, Florida, 33027
Central Sooner Research
Norman, Oklahoma, 73071
Clinical Neuroscience Solution, Inc
Orlando, Florida, 32801
Paddington Testing Co.
Philadelphia, Pennsylvania, 19103
Elite Clinical Studies
Phoenix, Arizona, 85018
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Atopic Dermatitis
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD
Read the detailed description
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD
At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the VAS scale (at least moderate).
The total duration of the study will be approximately 9 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a two week washout phase before reporting for a Baseline visit.
Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be conducted at Day 42 (Week 6).
Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual Analog Scale (VAS).
Blood and urine samples will be collected for standard safety laboratory tests and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study.
Investigators plan to enroll approximately 130 total patients.
Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- B244, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B244Biological
B244 suspension
VehicleBiological
Vehicle suspension
| Study group | Role | What they receive |
|---|---|---|
| B244 | Active comparator | B244 suspension in 30ml/bottle
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day. Receives: Biological: B244 |
| Vehicle | Placebo comparator | Vehicle, 30ml/bottle
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day. Receives: Biological: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
Measured: Baseline to Day 42
Secondary outcomes (1)
Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups
EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.
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 posted1 Aug 2017
- Study start15 Jan 2018
- Primary completion27 Feb 2019
- Study completion20 Mar 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 Atopic Dermatitis 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOBiome LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Responsible party
- Sponsor
- Investigators
- Judith Ng-Cashin, MD, Study director, Chief Medical OfficerSpiros Jamas, ScD, Study director, AOBiome LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235024
- Sponsor's protocol ID
- ADB244-001
- Status last verified
- Oct 2022
- First submitted
- 20 Jul 2017
- Last updated
- 10 Oct 2022
- 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 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03235024
- Acronym / sponsor ID
- ADB244-001
- Conditions
- Atopic Dermatitis Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- AOBiome LLCIndustry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Posted 10 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD
Detailed description
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD
At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the VAS scale (at least moderate).
The total duration of the study will be approximately 9 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a two week washout phase before reporting for a Baseline visit.
Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be conducted at Day 42 (Week 6).
Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual Analog Scale (VAS).
Blood and urine samples will be collected for standard safety laboratory tests and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study.
Investigators plan to enroll approximately 130 total patients.
Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
| Arm | Type | Receives |
|---|---|---|
| B244 | Active comparator | Biological: B244B244 suspension in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day. |
| Vehicle | Placebo comparator | Biological: VehicleVehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects ≥18 years of age
- In good general health as determined by a thorough medical history and physical examination, and vital signs
- Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of Hanifin and Rajka
- Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21
- A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus
Key exclusion criteria (19 listed)
- Pregnant and lactating women by urine pregnancy testing
- Subjects with any significant clinical abnormalities which may interfere with study participation
- Any skin condition which may interfere with evaluation of AD
- Atopic dermatitis only on the head or scalp
- Subjects with Atopic dermatitis on the face
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 |
|---|---|---|
| B244B244 suspension | Biological | B244 |
| VehicleVehicle suspension | Biological | Vehicle |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Baseline to Day 42
Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
1 secondary outcome
Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups
Time frame: Baseline to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- 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 LLC
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing B244 in people with Atopic Dermatitis Eczema, run by AOBiome LLC at 17 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 9 inclusion and 19 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 10 Oct 2022). 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-related Adverse Events as Assessed by CTCAE v4.0 (time frame: Baseline to Day 42). 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 10 Oct 2022.