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Clinical Efficacy and Safety of Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis

NCT03724240 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2018-10-30

No results posted yet for this study

Summary

This is a randomised, double-blind, placebo-controlled, international, multicentre, confirmatory Phase III study in patients with grass pollen-related allergic rhinoconjunctivitis. After having given written informed consent, the patients will be examined to establish eligibility according to inclusion/exclusion criteria. The eligible patients will be randomised to Placebo or gpASIT+™ treatment according to a 1:1 ratio. Study treatment will be administered before the start of the pollen season in 2019

Conditions

  • Hay Fever

Interventions

BIOLOGICAL

Placebo solution

4 x 2 injection over 21 days the dosage is100 µg/ml

BIOLOGICAL

gpASIT+TM

4 x 2 injection over 21 days the dosage is100 µg/ml

Sponsors & Collaborators

  • ASIT Biotech S.A.

    lead INDUSTRY

Principal Investigators

  • Bachert Claus, Prof Dr · Uz Gent-Gent, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-09-30
Completion
2019-12-31

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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 NCT03724240 on ClinicalTrials.gov