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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Dec 2025

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At a glance

  • Drugs B 244 (Primary)
  • Indications Atopic dermatitis; Eczema; Pruritus
  • Focus Registrational; Therapeutic Use
  • Sponsors AOBiome

Most Recent Events

  • 02 Dec 2025 According to an AOBiome media release, the regulatory agreement with the EMA's Pediatric Committee (PDCO) under the approved Pediatric Investigation Plan (PIP) enables the company to file an initial MAA with the EMA based on data from two pivotal trials and one open-label extension study in adolescents and adults, as endorsed by the U.S. FDA and Japan's PMDA, without the need for an additional comparator study.
  • 16 May 2023 According to an AOBiome media release, The trial was run in collaboration with Biorasi, LLC, a leading Clinical Research Organization.
  • 16 May 2023 According to an AOBiome media release, results from this trial were published in the Lancet's eClinicalMedicine, a peer-reviewed medical journal.

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