NCT02560948

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 11, 2018

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

September 23, 2015

Last Update Submit

October 10, 2018

Conditions

Hay Fever

Outcome Measures

Primary Outcomes (1)

  • Combined Symptom and Medication Score (CSMS)

    over the peak (corresponding to 14 consecutive days with highest pollen counts) of grass pollen season estimated between 3 and 6 months after treatment

Secondary Outcomes (15)

  • Combined Symptom and Medication Score (CSMS)

    over the entire grass pollen season estimated between 3 and 6 months after treatment

  • Symptom sub-scores (Eyes, Nose)

    over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment

  • Well days: number of days with symptomatic score below or equal to 2 and no rescue medication

    over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment

  • Lung Symptom Score (LLS: the average of coughing, wheezing, chest tightness and exercise induced dyspnoea scores) in asthmatic patients

    over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and over the pollen season estimated between 3 and 6 months after treatment

  • Total Symptom Score (TSS: the sum of the nose, eye and lung scores) in asthmatic patients

    over the peak period (14 consecutive days with highest pollen counts within grass pollen season) and the pollen season estimated between 3 and 6 months after treatment

  • +10 more secondary outcomes

Other Outcomes (6)

  • Production of grass pollen specific immunoglobulins IgE, IgG and IgG4

    up to 8 months

  • Production of blocking antibodies (FAB assay)

    up to 8 months

  • Reduction of Th2 response by measuring IL-4+ and IFN-gamma+ production

    up to 8 months

  • +3 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Biological: Placebo solution

gpASIT+TM

EXPERIMENTAL
Biological: gpASIT+TM

Interventions

Placebo solutionBIOLOGICAL

4 x 2 injections over 21 days

Placebo
gpASIT+TMBIOLOGICAL

4 x 2 injections over 21 days

gpASIT+TM

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Ghent

Ghent, Belgium

Location

Clinica dell'Azienda Opsedaliera Luigi Sacco

Milan, Italy

Location

Fundacion Jiménez Diaz

Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30844425DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ralph Mösges, Professor

    Private practice, Aachen, Germany

    PRINCIPAL INVESTIGATOR

  • Claus Bachert, Professor

    UZ Gent, Gent, Belgium

    PRINCIPAL INVESTIGATOR

  • Petr Panzner, MD

    University Hospital of Pilsen, Pilsen, Czech Republic

    PRINCIPAL INVESTIGATOR

  • Frédéric de Blay, Professor

    CHRU de Strasbourg, Strasbourg, France

    PRINCIPAL INVESTIGATOR

  • Enrico Iemoli, MD

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

    PRINCIPAL INVESTIGATOR

  • Joachin Sastre, Professor

    Fundación Jiménez Díaz, Madrid,Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 25, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 11, 2018

Record last verified: 2015-09

Locations

ES(1)IT(1)BE(1)