B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT04490109|
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : November 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Biological: B244 Biological: Vehicle||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||576 participants|
|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|
|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|
Experimental: B244 Suspension O.D. 5.0
One arm of 192 Subjects will be receiving a dose of B244 O.D. 5.0 suspension
Experimental: B244 Suspension O.D. 20.0
Second arm of 192 subjects will receive a dose of B244 O.D. 20.0 suspension
Placebo Comparator: Placebo
Third arm of 192 subjects will receive a vehicle dosing.
- 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
- 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)
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
|Contact: Hyun Kim, PhDfirstname.lastname@example.org|
|Contact: Connie Li, MEngemail@example.com|
|Study Director:||Hyun Kim, PhD||AOBiome LLC|