At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 240 enrolled
Drug / intervention
placebo +2 moredrug
Likely dose
AllerT low dose 50 microgramsfrom 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.
Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen
In Brief
A Phase 2 clinical trial evaluating placebo, AllerT low dose, and 1 other intervention for Allergic Rhinitis and Rhinoconjunctivitis. Completed, enrolled 240 participants across 24 sites in 7 countries.
Detailed Summary
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis, Rhinoconjunctivitis
CountriesDenmark, France, Latvia, Lithuania, Poland, Sweden, Switzerland
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedNov 2012
Primary CompletionSep 2013
TodayJul 2026
First PostedNov 2, 2012
Enrollment StartOct 1, 2012
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.7 years ago
Interventions
placebodrug
SC injections of placebo on days 1, 7, 14, 28 and 56
AllerT low dosedrug
SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
AllerT full dosedrug
SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56