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

NCT ID: NCT04490109

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 547 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-24
• Study Completion Date: 2022-01-07

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.

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.

Conditions

Atopic Dermatitis; Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

B244 Suspension O.D. 5.0

One arm of 192 Subjects will be receiving a dose of B244 O.D. 5.0 suspension

Group Type: EXPERIMENTAL

B244

Intervention Type: BIOLOGICAL

B244 suspension

B244 Suspension O.D. 20.0

Second arm of 192 subjects will receive a dose of B244 O.D. 20.0 suspension

Group Type: EXPERIMENTAL

B244

Intervention Type: BIOLOGICAL

B244 suspension

Placebo

Third arm of 192 subjects will receive a vehicle dosing.

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: BIOLOGICAL

Vehicle suspension

Interventions

B244

B244 suspension

Intervention Type: BIOLOGICAL

Vehicle

Vehicle suspension

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

bioRASI, LLC

INDUSTRY

Sponsor Role: collaborator

AOBiome LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyun Kim, PhD

Role: STUDY_DIRECTOR

AOBiome LLC

Locations

Cahaba Dermatology

Birmingham, Alabama, United States

Elite Clinical Studies, LLC

Phoenix, Arizona, United States

Cognitive Clinical Trials

Scottsdale, Arizona, United States

Dermatology Trial Associates

Bryant, Arkansas, United States

Applied Research Center of Arkansas, Inc

Little Rock, Arkansas, United States

Core Healthcare Group

Cerritos, California, United States

Encino Research Center

Encino, California, United States

Center for Dermatology, INC

Fremont, California, United States

Antelope Valley Clinical Trials

Lancaster, California, United States

Long Beach Clinical Trials Services

Long Beach, California, United States

L.A. Universal Research Center Inc

Los Angeles, California, United States

Providence Clinical Research

North Hollywood, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

IMMUNOe Research Centers

Centennial, Colorado, United States

Tampa Bay Medical Research

Clearwater, Florida, United States

Palm Beach Dermatology Group

Delray Beach, Florida, United States

South Coast Research Center, Inc

Miami, Florida, United States

D&H National Research Center

Miami, Florida, United States

Meridian International Research

Miami Gardens, Florida, United States

NAPA Research

Pompano Beach, Florida, United States

Clinical Research Trials of Florida, Inc

Tampa, Florida, United States

Moore Clinical Research

Tampa, Florida, United States

Medical Dermatology Associates of Chicago

Chicago, Illinois, United States

Clinical Investigation Specialists

Libertyville, Illinois, United States

Sneeze Wheeze & Itch Associates, LLC

Normal, Illinois, United States

Epiphany Dermatology

Overland Park, Kansas, United States

Meridian Clinical Research

Baton Rouge, Louisiana, United States

Continental Clinical Solutions

Towson, Maryland, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

Clarkston Dermatology

Clarkston, Michigan, United States

Onyx Clinical Reserach

Flint, Michigan, United States

mediSearch Clinical Trials

Saint Joseph, Missouri, United States

Thomas Dermatology

Henderson, Nevada, United States

JDR Dermatology Research, LLC

Las Vegas, Nevada, United States

ActivMed Practices & Research

Portsmouth, New Hampshire, United States

The Dermatology Group, P. C.

Verona, New Jersey, United States

Drug Trials Brooklyn

Brooklyn, New York, United States

Drug Trials America

Hartsdale, New York, United States

Saddick Research Group

New York, New York, United States

Dermatology Consulting Services, LLC

High Point, North Carolina, United States

Wake Research

Raleigh, North Carolina, United States

Clinical Research Solutions

Cleveland, Ohio, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Velocity Clinical Research

Medford, Oregon, United States

Dermdox Centers for Dematology

Sugarloaf, Pennsylvania, United States

Peak Research LLC

Upper Saint Clair, Pennsylvania, United States

Greater Providence Clinical Research

Cranston, Rhode Island, United States

AAPRI Research

Warwick, Rhode Island, United States

Omega Medical Research

Warwick, Rhode Island, United States

Dermatology & Laser Center of Charleston

Charleston, South Carolina, United States

Peak Research LLC

Fort Mill, South Carolina, United States

Clinical Research Solutions

Milan, Tennessee, United States

ACRC Trials

Plano, Texas, United States

Aspen Dermatology

Orem, Utah, United States

Advance Clinical Research

Salt Lake City, Utah, United States

Dominion Medical Associates

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37396805 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PRB244-01

Identifier Type: -

Identifier Source: org_study_id