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

NCT ID: NCT02560948

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 554 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo solution

Intervention Type: BIOLOGICAL

4 x 2 injections over 21 days

gpASIT+TM

Group Type: EXPERIMENTAL

gpASIT+TM

Intervention Type: BIOLOGICAL

4 x 2 injections over 21 days

Interventions

Placebo solution

4 x 2 injections over 21 days

Intervention Type: BIOLOGICAL

gpASIT+TM

4 x 2 injections over 21 days

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Allergy diagnosis:

• A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SARC) for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al 2001))
• A positive skin prick test (SPT - wheal diameter ≥ 3 mm) to grass pollen mixture, histamine wheal ≥ 3 mm, NaCl control reaction < 2 mm
• Specific IgE against grass pollen (with recombinant allergens - g213) > 0.7 kU/L
• Positive response to CPT with at least 10,000 SQ-E/mL of grass allergens
• Patients treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrollment
• For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014)

Exclusion Criteria

• Previous immunotherapy with grass allergens within the last 5 years
• Ongoing immunotherapy with grass allergens or any other allergens
• Patients with a history of anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin)
• Patients with partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
• Patients with chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the predicted value (ECSC) or with a peak expiratory flow (PEF) < 70% of the individual optimum value
• Patients symptomatic to inhaled allergens circulating during the grass pollen season (specific to each country: e.g. birch, hazel, mugwort, ragweed, olive, Alternaria alternata)
• Patients symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioTech Tools S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Mösges, Professor

Role: PRINCIPAL_INVESTIGATOR

Private practice, Aachen, Germany

Claus Bachert, Professor

Role: PRINCIPAL_INVESTIGATOR

UZ Gent, Gent, Belgium

Petr Panzner, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Pilsen, Pilsen, Czech Republic

Frédéric de Blay, Professor

Role: PRINCIPAL_INVESTIGATOR

CHRU de Strasbourg, Strasbourg, France

Enrico Iemoli, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica dell'Azienda Ospedaliera Luigi Sacco Di Milano, Milano, Italy

Joachin Sastre, Professor

Role: PRINCIPAL_INVESTIGATOR

Fundación Jiménez Díaz, Madrid,Spain

Locations

University Hospital Ghent

Ghent, , Belgium

Clinica dell'Azienda Opsedaliera Luigi Sacco

Milan, , Italy

Fundacion Jiménez Diaz

Madrid, , Spain

Countries

Belgium; Italy; Spain

References

Sharif H, Singh I, Kouser L, Mosges R, Bonny MA, Karamani A, Parkin RV, Bovy N, Kishore U, Robb A, Katotomichelakis M, Holtappels G, Derycke L, Corazza F, von Frenckell R, Wathelet N, Duchateau J, Legon T, Pirotton S, Durham SR, Bachert C, Shamji MH. Immunologic mechanisms of a short-course of Lolium perenne peptide immunotherapy: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2019 Sep;144(3):738-749. doi: 10.1016/j.jaci.2019.02.023. Epub 2019 Mar 5.

Reference Type: DERIVED

PMID: 30844425 (View on PubMed)

Other Identifiers

BTT-gpASIT009

Identifier Type: -

Identifier Source: org_study_id