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

NCT02560948 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2018-10-11

No results posted yet for this study

Summary

gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this study is to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis compared to placebo.

Conditions

  • Hay Fever

Interventions

BIOLOGICAL

Placebo solution

4 x 2 injections over 21 days

BIOLOGICAL

gpASIT+TM

4 x 2 injections over 21 days

Sponsors & Collaborators

  • BioTech Tools S.A.

    lead INDUSTRY

Principal Investigators

  • Ralph Mösges, Professor · Private practice, Aachen, Germany

  • Claus Bachert, Professor · UZ Gent, Gent, Belgium

  • Petr Panzner, MD · University Hospital of Pilsen, Pilsen, Czech Republic

  • Frédéric de Blay, Professor · CHRU de Strasbourg, Strasbourg, France

  • Enrico Iemoli, MD · Clinica dell'Azienda Ospedaliera Luigi Sacco Di Milano, Milano, Italy

  • Joachin Sastre, Professor · Fundación Jiménez Díaz, Madrid,Spain

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
2015-12-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Belgium
  • Italy
  • Spain

Study Locations

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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 NCT02560948 on ClinicalTrials.gov