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

NCT04490109 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PRB244-01
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 56

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.

Conditions

Atopic Dermatitis; Pruritus

Outcome Measures

Primary Outcomes (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."

  Baseline to Day 28

Secondary Outcomes (9)

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

  Baseline to Day 28

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

  Baseline to Day 28

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

  Baseline to Day 28

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

  Baseline to Day 28

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

  Baseline to Day 28

Other Outcomes (8)

• Mean Change in Investigator's Global Assessment (IGA)

  Baseline to Day 28

• Mean Change in Eczema Area Severity Index (EASI)

  Baseline to Day 28

• Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement

  Baseline to Day 28

Study Arms (3)

B244 Suspension O.D. 5.0

EXPERIMENTAL

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

Biological: B244

B244 Suspension O.D. 20.0

EXPERIMENTAL

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

Biological: B244

Placebo

PLACEBO COMPARATOR

Third arm of 192 subjects will receive a vehicle dosing.

Biological: Vehicle

Interventions

B244 BIOLOGICAL

B244 suspension

B244 Suspension O.D. 20.0; B244 Suspension O.D. 5.0

Vehicle BIOLOGICAL

Vehicle suspension

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• 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.
• a. 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.,

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• AOBiome LLC: lead
• bioRASI, LLC: collaborator

Study Sites (56)

Cahaba Dermatology

Birmingham, Alabama, 35244, United States

Location

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

Location

Cognitive Clinical Trials

Scottsdale, Arizona, 85260, United States

Location

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

Location

Applied Research Center of Arkansas, Inc

Little Rock, Arkansas, 72212, United States

Location

Core Healthcare Group

Cerritos, California, 90703, United States

Location

Encino Research Center

Encino, California, 91436, United States

Location

Center for Dermatology, INC

Fremont, California, 94538, United States

Location

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

Location

Long Beach Clinical Trials Services

Long Beach, California, 90806, United States

Location

L.A. Universal Research Center Inc

Los Angeles, California, 90057, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Palm Beach Dermatology Group

Delray Beach, Florida, 33484, United States

Location

South Coast Research Center, Inc

Miami, Florida, 33136, United States

Location

D&H National Research Center

Miami, Florida, 33155, United States

Location

Meridian International Research

Miami Gardens, Florida, 33014, United States

Location

NAPA Research

Pompano Beach, Florida, 33064, United States

Location

Clinical Research Trials of Florida, Inc

Tampa, Florida, 33607, United States

Location

Moore Clinical Research

Tampa, Florida, 33609, United States

Location

Medical Dermatology Associates of Chicago

Chicago, Illinois, 60654, United States

Location

Clinical Investigation Specialists

Libertyville, Illinois, 60048, United States

Location

Sneeze Wheeze & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Epiphany Dermatology

Overland Park, Kansas, 66215, United States

Location

Meridian Clinical Research

Baton Rouge, Louisiana, 70808, United States

Location

Continental Clinical Solutions

Towson, Maryland, 21204, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

Clarkston Dermatology

Clarkston, Michigan, 48346, United States

Location

Onyx Clinical Reserach

Flint, Michigan, 48507, United States

Location

mediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Thomas Dermatology

Henderson, Nevada, 89052, United States

Location

JDR Dermatology Research, LLC

Las Vegas, Nevada, 89148, United States

Location

ActivMed Practices & Research

Portsmouth, New Hampshire, 03801, United States

Location

The Dermatology Group, P. C.

Verona, New Jersey, 07044, United States

Location

Drug Trials Brooklyn

Brooklyn, New York, 11230, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Saddick Research Group

New York, New York, 10075, United States

Location

Dermatology Consulting Services, LLC

High Point, North Carolina, 27262, United States

Location

Wake Research

Raleigh, North Carolina, 27612, United States

Location

Clinical Research Solutions

Cleveland, Ohio, 44130, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

Velocity Clinical Research

Medford, Oregon, 97504, United States

Location

Dermdox Centers for Dematology

Sugarloaf, Pennsylvania, 18249, United States

Location

Peak Research LLC

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Greater Providence Clinical Research

Cranston, Rhode Island, 02920, United States

Location

AAPRI Research

Warwick, Rhode Island, 02886, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Dermatology & Laser Center of Charleston

Charleston, South Carolina, 29407, United States

Location

Peak Research LLC

Fort Mill, South Carolina, 29708, United States

Location

Clinical Research Solutions

Milan, Tennessee, 38358, United States

Location

ACRC Trials

Plano, Texas, 75024, United States

Location

Aspen Dermatology

Orem, Utah, 84058, United States

Location

Advance Clinical Research

Salt Lake City, Utah, 84117, United States

Location

Dominion Medical Associates

Richmond, Virginia, 23219, United States

Location

Related Publications (1)

• 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.

  PMID: 37396805 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Hyun Kim, Vice President Clinical Operations
• Organization: AOBiome Therapeutics

hkim@aobiome.com

617-639-9980

Study Officials

• Hyun Kim, PhD

  AOBiome LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, randomized, vehicle-controlled, randomized in a 1:1:1 ratio
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 28, 2020
• Study Start: June 24, 2020
• Primary Completion: December 10, 2021
• Study Completion: January 7, 2022
• Last Updated: January 28, 2025
• Results First Posted: December 19, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (56)