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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04490109
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
bioRASI, LLC
Information provided by (Responsible Party):
AOBiome LLC

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: B244 Biological: Vehicle Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind, randomized, vehicle-controlled, randomized in a 1:1:1 ratio
Primary Purpose: Treatment
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
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : June 10, 2021
Estimated Study Completion Date : June 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arm Intervention/treatment
Experimental: B244 Suspension O.D. 5.0
One arm of 192 Subjects will be receiving a dose of B244 O.D. 5.0 suspension
Biological: B244
B244 suspension

Experimental: B244 Suspension O.D. 20.0
Second arm of 192 subjects will receive a dose of B244 O.D. 20.0 suspension
Biological: B244
B244 suspension

Placebo Comparator: Placebo
Third arm of 192 subjects will receive a vehicle dosing.
Biological: Vehicle
Vehicle suspension




Primary Outcome Measures :
  1. Mean change in WI-NRS from baseline to Week 4 [ Time Frame: 4 weeks ]
    Assessing the efficacy of B244 by measuring the mean change in WI-NRS reported by subjects from baseline to Week 4


Secondary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: 11 weeks ]
    Assessing the safety and tolerability of B244 by monitoring the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects 18 to 65 years of age.
  2. Pruritus of at least 4 weeks duration prior to the initial Screening visit and during the 2 week washout period.

    a. 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.

  3. Worst Itch Numeric Rating Scale (WI-NRS) score ≥ 7 in the 24-hour period prior to the initial Screening as well as Baseline visits.
  4. Average weekly WI-NRS score ≥6 for each week of the washout period, as recorded in the eDiary.
  5. 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.

    1. 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.
    2. 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.
  6. 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.

    a. Subjects' BSA can include face and body OR body alone BUT NOT face alone.

  7. An Investigator Global Assessment (IGA) score of 2-3 at Screening and Baseline.
  8. 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.
  9. Judged to be in good health in the investigator's opinion.,

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Treatment with systemic corticosteroids within 4 weeks prior to randomization.
  4. 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.
  5. 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.

    a. 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.

  6. 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.
  7. 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).
  8. Treatment with biologic therapies within 12 weeks or 5 half-lives prior to randomization, whichever is longer.
  9. Use of an indoor tanning facility within 4 weeks prior to randomization.
  10. Treatment with any investigational therapy within 4 weeks prior to randomization.
  11. Allergen immunotherapy within 6 months prior to randomization.
  12. Prior use of AO+ Mist.
  13. 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.
  14. History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt.
  15. Known active hepatitis infection.
  16. Known history of human immunodeficiency virus (HIV) infection.
  17. 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.
  18. Currently pregnant or breastfeeding, or male subject with a pregnant or breastfeeding partner.
  19. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490109


Contacts
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Contact: Hyun Kim, PhD 781-439-7159 hkim@aobiome.com
Contact: Aliss Lacy, MS alacy@aobiome.com

Locations
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United States, Arizona
Elite Clinical Studies Recruiting
Phoenix, Arizona, United States, 85018
Contact: Nicole Ossino    602-788-4868    Nicole@eliteclinicalstudies.com   
United States, California
Encino Research Center Recruiting
Encino, California, United States, 91436
Contact: Sarah Emert    818-788-5060    sarah@drraoof.com   
Long Beach Clinical Trials Services Recruiting
Long Beach, California, United States, 90806
Contact: Jessica Fox    562-997-3869      
United States, Florida
Veritas Research Corp Recruiting
Miami, Florida, United States, 33126
Contact: Xavier Xavier Panchana    305-364-5703    xpanchana@veritasresearchcorp.com   
Clinical Research Trials of Florida ,Inc. Recruiting
Tampa, Florida, United States, 33607
Contact: Sady A Alpizar, MD    813-873-8102    s.alpizar.md@gmail.com   
Moore Clinical Research Recruiting
Tampa, Florida, United States, 33609
Contact: Theresa Lopez    813-948-7550 ext 402      
United States, Michigan
Clarkston Skin Research Recruiting
Clarkston, Michigan, United States, 48349
Contact: Brianna Cole, CCRC    248-620-3376 ext 116      
Principal Investigator: Wendy McFalda, MD         
United States, North Carolina
Wake Research Associates, LLC Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Marion Peoples    919-781-2514    mpeoples@wakeresearch.com   
Sponsors and Collaborators
AOBiome LLC
bioRASI, LLC
Investigators
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Study Director: Hyun Kim, PhD AOBiome LLC
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Responsible Party: AOBiome LLC
ClinicalTrials.gov Identifier: NCT04490109    
Other Study ID Numbers: PRB244-01
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eczema
Dermatitis, Atopic
Dermatitis
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations