At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 547 enrolled
Drug / intervention
B244 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating B244 and Vehicle for Atopic Dermatitis and Pruritus. Completed, enrolled 547 participants across 56 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis, Pruritus
CountriesUnited States
CollaboratorsbioRASI, LLC
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartJun 2020
First PostedJul 2020
Primary CompletionDec 2021
Study CompletionJan 2022
TodayJul 2026
First PostedJul 28, 2020
Enrollment StartJun 24, 2020
Primary CompletionDec 10, 2021
Study CompletionJan 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.9 years ago
Interventions
B244biological
B244 suspension
Vehiclebiological
Vehicle suspension