Loading clinical trials...

Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis

Clinical Efficacy, Immunogenicity, Clinical Tolerability and Assessment of Safety of gpASIT+TM Administered Orally, According to Two Administration Schedules, for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

NCT01308021•BioTech Tools S.A.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age between 18 and 50 years
•Subject has given written informed consent
•The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
•Male or non pregnant, non-lactating female
•Female unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
•Allergy \> 2 years

Exclusion Criteria

•Subjects with current immunotherapy or subjects who underwent a previous immunotherapy within the last 2 years
•Subjects with perennial asthma
•Subjects with a VC \< 80% and FEV1 \< 70%
•Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
•Documented evidence of chronic sinusitis (as determined by investigator)
•Subjects with a history of hepatic or renal disease
•Subjects symptomatic to perennial inhalant allergens
•Subject with malignant disease, autoimmune disease
•Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD, ...)
•Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc…)
+16 more criteria

Locations (19)

CHR Saint Joseph Warquignies

Boussu, Belgium

AZ Sint Lucas

Bruges, Belgium

Clinique du Parc Léopold

Brussels, Belgium

UZ Brussel

Brussels, Belgium

UCL Saint Luc

Brussels, Belgium

UZ Antwerpen

Edegem, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

CHR Citadelle

Liège, Belgium

CHU Sart-Tilman

Liège, Belgium

Key Dates

Start Date

December 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

December 1, 2011

Last Updated

May 26, 2014

Enrollment

202

ACTUAL participants

Conditions

Grass Pollen AllergyHay Fever

Interventions

gpASIT+TM

BIOLOGICAL

gpASIT+TM

BIOLOGICAL

Placebo

BIOLOGICAL

Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction

NCT04502966

Allergic RhinoconjunctivitisGrass Pollen Allergy

View study

COMPLETEDNA

A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment

NCT05560698

Grass Pollen AllergyRhinoconjunctivitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 26, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis

Inclusion Criteria

Exclusion Criteria

Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction

A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment

Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

Observational Study With PASCALLERG ® in Patients With Hay Fever

PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)

Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Cetirizine HCl Syrup vs. Loratadine Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)