AzTrials
AzTrials

Atopic DermatitisPhase 2NCT04490109

B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis

A Phase 2 study testing B244 in people with Atopic Dermatitis and Pruritus, run by AOBiome LLC at 56 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a double-blind, randomized, vehicle-controlled study to assess the efficacy, safety, and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of atopic dermatitis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Atopic Dermatitis, Pruritus
What is being tested?
B244
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
547 participants
Where
56 sitesUnited States
Study dates
24 Jun 2020to 7 Jan 2022
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects 18 to 65 years of age.
  • Pruritus of at least 4 weeks duration prior to the initial Screening visit and during the 2 week washout period.
  • Subjects using stable doses of oral H1 antihistamines at the initial Screening visit must be willing to continue these at the same doses and frequencies throughout the study inclusive of the follow-up period.
  • Worst Itch Numeric Rating Scale (WI-NRS) score ≥ 7 in the 24-hour period prior to the initial Screening as well as Baseline visits.
  • Average weekly WI-NRS score ≥6 for each week of the washout period, as recorded in the eDiary.
  • A history of atopic dermatitis for greater than 12 months consistent with a diagnosis of atopic dermatitis, as defined by the 2014 American Academy of Dermatology (AAD) Guidelines of Care for the Management of Atopic Dermatitis.
Show all 13Show fewer
  • Subjects using bland emollients at the initial Screening visit will be allowed to continue to use their emollient of choice at the same dose and frequency throughout the study.
  • Subjects using low- to mid-potency topical corticosteroids at the initial Screening visit will be allowed to use their topical corticosteroid of choice at the same dose and frequency no more than 7 days per month throughout the study as rescue medication.
  • A minimum of 10% and not more than 40% 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) at Screening and Baseline.
  • Subjects' BSA can include face and body OR body alone BUT NOT face alone.
  • An Investigator Global Assessment (IGA) score of 2-3 at Screening and Baseline.
  • Willing and able to complete once-daily eDiary entries within a consistent timeframe for the duration of the study and have ≥80% eDiary compliance rate during the washout period.
  • Judged to be in good health in the investigator's opinion.,

Who cannot join

  • Clearly defined etiology for pruritus other than atopic dermatitis. These include but are not limited to urticaria, psoriasis or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, untreated hyperthyroidism, parasite presence and presence of acute infection either systemically or in the AD lesions.
  • Presence of any acute condition which may risk inducing an atopic dermatitis flare during the course of the study, such as impetigo or active herpes simplex infection.
  • Treatment with systemic corticosteroids within 4 weeks prior to randomization.
  • Treatment with Class III or higher potency topical corticosteroids or any topical anti-pruritic therapies (other than stable doses of low- or mid-potency topical corticosteroids or bland emollients) within 4 weeks prior to randomization.
  • Treatment with systemic therapies with recognized anti-pruritic (e.g. tricyclic antidepressants, sedatives, tranquilizers, gabapentin, marijuana or other cannabinoids, opioid receptor agonists/antagonists) or pruritic (e.g. opioids, angiotensin-converting enzyme inhibitors, cocaine,,antimalarials) properties within 4 weeks prior to randomization.
  • Stable doses of H1 antihistamines will be permitted. Subjects must be willing to continue these at the same doses and frequencies throughout the study inclusive of the follow-up period.
Show all 20Show fewer
  • Any clinically significant changes in type, dose, or frequency of bland emollients, low- or mid-potency corticosteroids, and/or oral H1 antihistamines throughout the study from screening to follow-up.
  • Treatment with systemic immunosuppressive/ immunomodulatory therapies within 4 weeks prior to randomization (including but not limited to phosphodiesterase-4 inhibitors, cyclosporine, mycophenolate-mofetil, methotrexate, azathioprine, interferon-gamma, or phototherapy).
  • Treatment with biologic therapies within 12 weeks or 5 half-lives prior to randomization, whichever is longer.
  • Use of an indoor tanning facility within 4 weeks prior to randomization.
  • Treatment with any investigational therapy within 4 weeks prior to randomization.
  • Allergen immunotherapy within 6 months prior to randomization.
  • Prior use of AO+ Mist.
  • History of malignancy within 5 years prior to randomization, with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
  • History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt.
  • Known active hepatitis infection.
  • Known history of human immunodeficiency virus (HIV) infection.
  • Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
  • Currently pregnant or breastfeeding, or male subject with a pregnant or breastfeeding partner.
  • Females of childbearing potential who are unable or unwilling to practice highly effective contraception (pregnancy prevention); fertile males who are unable or unwilling to use condoms with female partners of childbearing potential.

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326

  • Meridian Clinical Research

    Baton Rouge, Louisiana, 70808

  • Cahaba Dermatology

    Birmingham, Alabama, 35244

  • Drug Trials Brooklyn

    Brooklyn, New York, 11230

  • Dermatology Trial Associates

    Bryant, Arkansas, 72022

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

  • Core Healthcare Group

    Cerritos, California, 90703

  • Dermatology & Laser Center of Charleston

    Charleston, South Carolina, 29407

  • Medical Dermatology Associates of Chicago

    Chicago, Illinois, 60654

  • Clarkston Dermatology

    Clarkston, Michigan, 48346

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Clinical Research Solutions

    Cleveland, Ohio, 44130

  • Greater Providence Clinical Research

    Cranston, Rhode Island, 02920

  • Palm Beach Dermatology Group

    Delray Beach, Florida, 33484

  • Encino Research Center

    Encino, California, 91436

  • Onyx Clinical Reserach

    Flint, Michigan, 48507

  • Peak Research LLC

    Fort Mill, South Carolina, 29708

  • Center for Dermatology, INC

    Fremont, California, 94538

  • Drug Trials America

    Hartsdale, New York, 10530

  • Thomas Dermatology

    Henderson, Nevada, 89052

  • Dermatology Consulting Services, LLC

    High Point, North Carolina, 27262

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • JDR Dermatology Research, LLC

    Las Vegas, Nevada, 89148

  • Clinical Investigation Specialists

    Libertyville, Illinois, 60048

  • Applied Research Center of Arkansas, Inc

    Little Rock, Arkansas, 72212

  • Long Beach Clinical Trials Services

    Long Beach, California, 90806

  • L.A. Universal Research Center Inc

    Los Angeles, California, 90057

  • Velocity Clinical Research

    Medford, Oregon, 97504

  • South Coast Research Center, Inc

    Miami, Florida, 33136

  • D&H National Research Center

    Miami, Florida, 33155

  • Meridian International Research

    Miami Gardens, Florida, 33014

  • Clinical Research Solutions

    Milan, Tennessee, 38358

  • Saddick Research Group

    New York, New York, 10075

  • Sneeze Wheeze & Itch Associates, LLC

    Normal, Illinois, 61761

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118

  • Aspen Dermatology

    Orem, Utah, 84058

  • Epiphany Dermatology

    Overland Park, Kansas, 66215

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • ACRC Trials

    Plano, Texas, 75024

  • NAPA Research

    Pompano Beach, Florida, 33064

  • ActivMed Practices & Research

    Portsmouth, New Hampshire, 03801

  • Wake Research

    Raleigh, North Carolina, 27612

  • Dominion Medical Associates

    Richmond, Virginia, 23219

  • mediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Advance Clinical Research

    Salt Lake City, Utah, 84117

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Cognitive Clinical Trials

    Scottsdale, Arizona, 85260

  • Dermdox Centers for Dematology

    Sugarloaf, Pennsylvania, 18249

  • Clinical Research Trials of Florida, Inc

    Tampa, Florida, 33607

  • Moore Clinical Research

    Tampa, Florida, 33609

  • Continental Clinical Solutions

    Towson, Maryland, 21204

  • Peak Research LLC

    Upper Saint Clair, Pennsylvania, 15241

  • The Dermatology Group, P. C.

    Verona, New Jersey, 07044

  • AAPRI Research

    Warwick, Rhode Island, 02886

  • Omega Medical Research

    Warwick, Rhode Island, 02886

Other trials in United States

About this study

Official title: A Phase II, Randomized, Double-Blind, Vehicle Controlled Study of the Efficacy, Safety, and Tolerability of B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis

This is a double-blind, randomized, vehicle-controlled study to assess the efficacy, safety, and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of atopic dermatitis. Subjects who meet the study entry criteria will be randomized in a 1:1:1 ratio to receive twice daily topical doses of B244 O.D. 5.0, B244 O.D. 20.0, or vehicle (placebo) for 4 weeks.

Read the detailed description

This is a Prospective, Vehicle Controlled, Double-Blind, Multicenter, Randomized Phase II Trial, comparing the effect of twice daily B244 applications for 4 weeks vs vehicle applications on treatment of mild to moderate pruritus associated with atopic dermatitis.

  • Approximately 576 subjects may be enrolled.
  • The total duration of the study will be approximately 11 weeks. Participants will report for a Screening visit and if all inclusion/exclusion criteria are met, subjects will go through a two-week washout phase before reporting for a Baseline visit.
  • After screening and baseline, participants will be randomized to one of two doses of B244 or vehicle application for 4 weeks.
  • Randomization will be 1:1:1 so that an equal number of patients will be treated in each Arm of the study.
  • All B244 randomized subjects will be treated at the dose of O.D. 5.0 or O.D. 20.0
  • Subjects must be willing and able to complete diary within a consistent time frame on a daily basis and to comply with restrictions on allowable therapies for the duration of the study.
  • All subjects will attend a screening visit not more than 21 days prior to Baseline (Day 0).
  • Subjects will be required to return to the clinic at Baseline, Day 14 (Week 2) and Day 28 (Week 4) visits. All subjects will be asked to attend a Week 8 follow-up visit 4 weeks (28 (±3) days) after the last dose of study medication.
  • Subjects will apply a total of 10 pumps of IP per application across all affected areas twice-a-day (i.e. 10 pumps in the morning and 10 pumps again at night) for 4 weeks.
  • Safety evaluations will consist of review of participant's medical history at screening and on-going assessment of adverse events reported throughout the study duration.
Being tested
B244, Vehicle
Medical subject headings
Dermatitis, Atopic, Pruritus

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 groups in NCT04490109
Study groupRoleWhat they receive
B244 Suspension O.D. 5.0ExperimentalOne arm of 192 Subjects will be receiving a dose of B244 O.D. 5.0 suspension
Receives: Biological: B244
B244 Suspension O.D. 20.0ExperimentalSecond arm of 192 subjects will receive a dose of B244 O.D. 20.0 suspension
Receives: Biological: B244
PlaceboPlacebo comparatorThird arm of 192 subjects will receive a vehicle dosing.
Receives: Biological: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Measured: Baseline to Day 28

Secondary outcomes (9)

  1. Proportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Measured: Baseline to Day 28

  2. Proportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Measured: Baseline to Day 28

  3. Mean Change in Average Itch Numeric Rating Scale (AI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."

    Measured: Baseline to Day 28

  4. Proportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."

    Measured: Baseline to Day 28

  5. Proportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."

    Measured: Baseline to Day 28

  6. Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Measured: Baseline to Day 14

  7. Proportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Measured: Baseline to Day 14

  8. Mean Change in Patient Oriented Eczema Measure (POEM)

    The Patient Oriented Eczema Measure (POEM) is a tool developed by the University of Nottingham, United Kingdom, for monitoring atopic dermatitis severity. The subject will complete the questionnaire at each of the assessment timepoints as outlined. Each of the 7 questions in the POEM questionnaire carries equal weight and is scored from 0 to 4: No days = 0. 1 to 2 days = 1. 3 to 4 days = 2. 5 to 6 days = 3. Every day = 4. Scores are then added to yield a total score of 0 to 28; higher scores mean the greater the severity of atopic dermatitis.

    Measured: Baseline to Day 28

  9. Mean Change in 5-D Pruritus Scale

    The 5-D Pruritus Scale is a validated, multi-dimensional measure of itching that assesses the five domains of degree (score 1-5: 1=not present, 2=mild, 3=moderate, 4=severe, 5=unbearable), duration (score 1-5: 1=less than 6hrs/day, 2=6-12hrs/day, 3=12-18hrs/day, 4=18-23hrs/day, 5=all day), direction (score 1-5: 1=completely resolved, 2=much better/still present, 3=little bit better/still present, 4=unchanged, 5=getting worse), disability (score 1-5: 1=never affects activity, 2=rarely affects activity, 3=occasionally affects activity, 4=frequently affects activity, 5=always affects activity; highest activity score is taken), and distribution (check boxes of affected body parts; 0-2 body parts=score of 1, 3-5=score of 2, 6-10=score of 3, 11-13=score of 4, 14-16=score of 5).

    The domains are scored separately and then summed together to obtain a total 5-D score, ranging from 5 (no pruritus) to 25 (most severe pruritus). Subjects rate their symptoms over the preceding 2-week period.

    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.

  1. First posted28 Jul 2020
  2. Study start24 Jun 2020
  3. Primary completion10 Dec 2021
  4. Study completion7 Jan 2022

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
547 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04490109
Sponsor's protocol ID
PRB244-01
Status last verified
Jan 2025
First submitted
16 Jul 2020
Last updated
28 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Silverberg JI, Lio PA, Simpson EL, Li C, Brownell DR, Gryllos I, Ng-Cashin J, Krueger T, Swaidan VR, Bliss RL, Kim HD. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: a randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 May 16;60:102002. doi: 10.1016/j.eclinm.2023.102002. eCollection 2023 Jun.

    PubMed 37396805

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing B244 in people with Atopic Dermatitis and Pruritus, run by AOBiome LLC at 56 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 20 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 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 19 Dec 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?

Mean Change in Worst Itch Numeric Rating Scale (WI-NRS) (time frame: Baseline to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04490109, which also lists 1 linked publication.

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 28 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in