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A one-year placebo-controlled phase III trial evaluating the efficacy and safety of the house dust mite (HDM) SLIT-tablet in children (5-11 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma

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Trial Profile

A one-year placebo-controlled phase III trial evaluating the efficacy and safety of the house dust mite (HDM) SLIT-tablet in children (5-11 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Mar 2025

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At a glance

Most Recent Events

  • 07 Mar 2025 According to an ALK-Abello media release, based on data from this study Health Canada has approved ALK ACARIZAX tablet for use in children, aged 5 to 11, with house dust mite (HDM) allergy.
  • 28 Feb 2025 According to an ALK-Abello media release, company announced that the U.S. Food and Drug Administration (FDA) expanded its indication of ODACTRA (House Dust Mite Allergen Tablet) for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, to now include children ages 5 through 11 years, in addition to patients 12 through 65 years of age. The approval was based, in part, on data from this Phase 3 clinical trial.
  • 27 Feb 2025 According to an ALK-Abello media release, Based on results from MT-12 trial,the company received an approval from US FDA for ODACTRA tablet for use in young children with house dust mite (HDM) allergy.

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