Subcutaneous Allergen Immunotherapy in Adults Allergic to House Dust Mites: A Phase 3 Randomized Controlled Trial.

ABSTRACT:

Background

Subcutaneous allergen immunotherapy (SCIT) has a longstanding history as a safe and effective treatment. Nevertheless, to meet the European Medicines Agency's regulatory requirements for continued market authorization, its efficacy and safety must be confirmed in a pivotal Phase III trial.

Objective

Based on a successful Phase II dose-finding study, the aim was to confirm the safety and efficacy of a subcutaneous house dust mites (HDM) preparation in a randomized controlled trial using an optimal higher dose than the current maintenance dose.

Method

Seven hundred sixty-seven subjects were randomized in a 1:1 ratio to 1-year treatment with SCIT-product at a dose of 50,000 AUeq/mL or placebo. Out of these, 682 subjects completed the study. The primary endpoin

SUBMITTER: Bachert C 

PROVIDER: S-EPMC12666762 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature