MedTrace Logo

Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy

NCT02556801 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-09-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Allergic Rhinitis
  • Allergic Rhinoconjunctivitis

Interventions

BIOLOGICAL

SUBLIVAC FIX Phleum Prat.

sublingual daily administration

Sponsors & Collaborators

  • HAL Allergy

    lead INDUSTRY

Principal Investigators

  • Peter Couroux, MD · Inflamax

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02556801 on ClinicalTrials.gov