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

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.

Timeline

Start

2020-06-24

Primary completion

2021-12-10

Completion

2022-01-07

Outcome

Met primary endpoint

registry analysis (superiority test); B244 O.D. 5.0 vs Vehicle; p = 0.0148; ANCOVA NCT04490109 ↗

registry analysis (superiority test); B244 O.D. 20.0 vs Vehicle; p = 0.0143; ANCOVA NCT04490109 ↗

paper The WI-NRS score was reduced by 34% (-2.8 B244 vs -2.1 placebo, p = 0.014 and p = 0.015 for OD 20.0 and OD 5.0) PMID 37396805 ↗

release “The trial met all primary and secondary endpoints” aobiome.com ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	B244	Other / unclassified	5 unknown	Topical
Subject	B244	Other / unclassified	20 unknown	Topical

Indications