At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 112 enrolled
Drug / intervention
Mitizax +1 moredrug
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 Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With Allergic Rhinitis and/or Atopic Asthma Induced by House Dust Mites
In Brief
A Phase 3 clinical trial evaluating Mitizax and Placebo for Allergy and 2 related conditions. Completed, enrolled 112 participants across 9 sites in 2 countries.
Detailed Summary
To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelarus, Russia
CollaboratorsLinical Co., Ltd., Datamap
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedNov 2015
Primary CompletionJun 2016
TodayJul 2026
First PostedNov 4, 2015
Enrollment StartOct 1, 2015
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.7 years ago
Interventions
Mitizaxdrug
Allergen extract
Placebodrug
Placebo tablet