At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 168 enrolled
Drug / intervention
SUBLIVAC FIX Phleum Prat.biological
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 Single-center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Relative Efficacy and Safety of Immunotherapy With SUBLIVAC FIX Phleum Pratense in Grass Pollen-Allergic Subjects With IgE-Mediated Seasonal ARC
In Brief
A Phase 2 clinical trial evaluating SUBLIVAC FIX Phleum Prat. for Allergic Rhinitis and Allergic Rhinoconjunctivitis. Completed, enrolled 168 participants across 1 site.
Detailed Summary
The purpose of this study is to assess safety, tolerability and demonstrate a dose response signal using Total Symptom Score (TSS), based on challenges with grass pollen in an Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo. The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis, Allergic Rhinoconjunctivitis
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedSep 2015
Primary CompletionOct 2016
TodayJul 2026
First PostedSep 22, 2015
Enrollment StartSep 1, 2015
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.8 years ago
Interventions
SUBLIVAC FIX Phleum Prat.biological
sublingual daily administration