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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490109
• Other study ID #: PRB244-01
• Status: Completed
• Phase: Phase 2
• Start date: June 4, 2020
• Est. completion date: January 7, 2022

Study information

• Verified date: October 2022
• Source: AOBiome LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: January 7, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Pruritus

Intervention

Biological:
• B244
B244 suspension
• Vehicle
Vehicle suspension

Locations

Country	Name	City	State
United States	Oakland Hills Dermatology	Auburn Hills	Michigan
United States	Meridian Clinical Research	Baton Rouge	Louisiana
United States	Cahaba Dermatology	Birmingham	Alabama
United States	Drug Trials Brooklyn	Brooklyn	New York
United States	Dermatology Trial Associates	Bryant	Arkansas
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	Core Healthcare Group	Cerritos	California
United States	Dermatology & Laser Center of Charleston	Charleston	South Carolina
United States	Clarkston Dermatology	Clarkston	Michigan
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Clinical Research Solutions	Cleveland	Ohio
United States	Greater Providence Clinical Research	Cranston	Rhode Island
United States	Encino Research Center	Encino	California
United States	Onyx Clinical Reserach	Flint	Michigan
United States	Center for Dermatology, INC	Fremont	California
United States	Drug Trials America	Hartsdale	New York
United States	Dermatology Consulting Services, LLC	High Point	North Carolina
United States	Antelope Valley Clinical Trials	Lancaster	California
United States	JDR Dermatology Research, LLC	Las Vegas	Nevada
United States	Applied Research Center of Arkansas, Inc	Little Rock	Arkansas
United States	Long Beach Clinical Trials Services	Long Beach	California
United States	L.A. Universal Research Center Inc	Los Angeles	California
United States	Crisor LLC C/O Clinical Research Institute of Southern Oregon, Inc	Medford	Oregon
United States	D&H National Research Center	Miami	Florida
United States	South Coast Research Center, Inc	Miami	Florida
United States	Meridian International Research	Miami Gardens	Florida
United States	Clinical Research Solutions	Milan	Tennessee
United States	Saddick Research Group	New York	New York
United States	Sneeze Wheeze & Itch Associates, LLC	Normal	Illinois
United States	Providence Clinical Research	North Hollywood	California
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Aspen Dermatology	Orem	Utah
United States	Epiphany Dermatology	Overland Park	Kansas
United States	Elite Clinical Studies, LLC	Phoenix	Arizona
United States	ACRC Trials	Plano	Texas
United States	NAPA Research	Pompano Beach	Florida
United States	ActivMed Practices & Research	Portsmouth	New Hampshire
United States	Wake Research	Raleigh	North Carolina
United States	Dominion Medical Associates	Richmond	Virginia
United States	mediSearch Clinical Trials	Saint Joseph	Missouri
United States	Advance Clinical Research	Salt Lake City	Utah
United States	Syrentis Clinical Research	Santa Ana	California
United States	Cognitive Clinical Trials	Scottsdale	Arizona
United States	Dermdox Centers for Dematology	Sugarloaf	Pennsylvania
United States	Clinical Research Trials of Florida, Inc	Tampa	Florida
United States	Moore Clinical Research	Tampa	Florida
United States	Continental Clinical Solutions	Towson	Maryland
United States	Peak Research LLC	Upper Saint Clair	Pennsylvania
United States	The Dermatology Group, P. C.	Verona	New Jersey
United States	AAPRI Research	Warwick	Rhode Island
United States	Omega Medical Research	Warwick	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
AOBiome LLC	bioRASI, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in WI-NRS from baseline to Week 4	Assessing the efficacy of B244 by measuring the mean change in WI-NRS reported by subjects from baseline to Week 4	4 weeks
Secondary	Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Assessing the safety and tolerability of B244 by monitoring the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	11 weeks