CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 151 enrolled
Drug / intervention
Allergovac Depot +5 morebiological
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.

Search/NCT01567306
NCT01567306Phase 2Completed
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Phase II, Multicenter, Randomized, Double Blind Study, With Subcutaneous Immunotherapy At Different Doses, in Parallel Groups and Placebo-Controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Phleum Pratense

Roxall Medicina España S.A·interventional·Posted Mar 30, 2012·Updated Apr 29, 2019

In Brief

A Phase 2 clinical trial evaluating Allergovac Depot and Placebo for Allergic Rhinoconjunctivitis. Completed, enrolled 151 participants across 10 sites in 2 countries.

Detailed Summary

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study is to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen extract subcutaneous vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinoconjunctivitis
CountriesPortugal, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2012
Enrollment StartOct 1, 2011
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.3 years ago

Interventions

Allergovac Depotbiological

Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Allergovac Depotbiological

Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Allergovac Depotbiological

Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Allergovac Depotbiological

Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Allergovac Depotbiological

Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Placebobiological

Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.