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

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

Study Overview

• Status: Completed
• Conditions: Hay Fever; Grass Pollen Allergy
• Intervention / Treatment: Biological: gpASIT+TM; Biological: gpASIT+TM; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Boussu, Belgium, 7300
    • CHR Saint Joseph Warquignies
  • Brugge, Belgium, 8310
    • Az Sint Lucas
  • Brussels, Belgium, 1090
    • UZ Brussel
  • Brussels, Belgium, 1040
    • Clinique du Parc Leopold
  • Brussels, Belgium, 1200
    • UCL Saint Luc
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
  • Liège, Belgium, 4000
    • CHR Citadelle
  • Mons, Belgium, 7000
    • CHU Ambroise Pare
  • Yvoir, Belgium, 5530
    • UCL Mont Godinne
• France
  • Lille, France, 59037
    • CHRU Lille
  • Lille, France, 59020
    • Hopital Saint Vincent de Paul
  • Nantes, France, 44000
    • Private Practice
  • Nantes, France, 44400
    • Private Practice
  • Reims, France, 51100
    • Chu Reims
  • Strasbourg, France, 67091
    • CHRU Strasbourg
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • CH Luxembourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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…)
• Subjects requiring beta-blockers medication
• Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
• Subject with febrile illness (> 37.5°C, oral)
• A known positive serology for HIV-1/2, HBV or HCV
• The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
• Receipt of blood or a blood derivative in the past 6 months preceding trial entry
• Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial
• Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial
• Use of long-acting antihistamines
• Any condition which could be incompatible with protocol understanding and compliance
• Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
• Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
• Participation in another clinical trial and/or treatment with an experimental drug within the last 2 years
• A history of hypersensitivity to the excipients
• Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
• Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Biological: Placebo; Placebo entero-coated capsules
EXPERIMENTAL: gpASIT400; gpASIT+TM 400 µg	Biological: gpASIT+TM; entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days; Biological: gpASIT+TM; entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days
EXPERIMENTAL: gpASIT800; gpASIT+TM 800 µg	Biological: gpASIT+TM; entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days; Biological: gpASIT+TM; entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of gpASIT+TM on the clinical efficacy of the subjects	The following parameter will be assessed: rhinoconjunctivitis total symptom score	grass pollen season 2011 (April to July)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical tolerability and safety of the treatment	The following parameters will be assessed: general physical status, vital signs, haematological parameters, general blodd biochemistry parameters, all (serious) adverse events, immunological analysis (total IgG, IgE) and inflammatory parameters (CRP, sedimentation rate)	8 months
Impact of gpASIT+TM on the immunological status of the subjects	The following parameter will be assessed: allergen-specific immunoglobulin concentrations	screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011)
Impact of gpASIT+TM on the clinical status of the subjects	The average daily symptom and rescue medication scores will be assessed.	grass pollen season 2011 (April-July)
Impact of gpASIT+TM on the quality of life of the subjects	The quality of life will be assessed by the use of validated questionnaires.	grass pollen season 2011 (April-July)

Collaborators and Investigators

• Sponsor: BioTech Tools S.A.
• Investigators: Principal Investigator: Claus Bachert, MD, UZ Ghent; Principal Investigator: Jan Ceuppens, MD, UZ Leuven; Principal Investigator: Didier Ebo, MD, UZ Antwerpen; Principal Investigator: Jean-Luc Halloy, MD, CHR Warquignies; Principal Investigator: Stijn Hallewyck, MD, Universitair Ziekenhuis Brussel; Principal Investigator: Renaud Louis, MD, Centre Hospitalier Universitaire de Liege; Principal Investigator: Catherine Mbasoa, MD, Clinique du Parc Léopold Bruxelles; Principal Investigator: Charles Pilette, MD, UCL Saint Luc Bruxelles; Principal Investigator: Hélène Simonis, MD, CHR Citadelle Liège; Principal Investigator: Olivier Vandenplas, MD, UCL Mont Godinne Yvoir; Principal Investigator: Christoph Verhoye, MD, AZ Sint-Lucas Brugge; Principal Investigator: Patricia Wackenier, MD, CHU Ambroise-Paré - Mons; Principal Investigator: Frédéric De Blay, MD, CHRU Strasbourg; Principal Investigator: Marie-Christine Castelain, MD, Hôpital Saint Vincent de Paul Lille; Principal Investigator: François Lavaud, MD, CHRU Reims; Principal Investigator: Benoît Wallaert, MD, CHU Lille; Principal Investigator: François Wessel, MD, Private Practice Nantes; Principal Investigator: Bruno Lebeaupin, MD, Private Practice Nantes; Principal Investigator: François Hentges, MD, CHL Luxembourg; Principal Investigator: François Durand Perdriel, MD, Private Practice Nantes; Principal Investigator: François Spirlet, MD, CH de Dinant

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: February 28, 2011
• First Submitted That Met QC Criteria: March 2, 2011
• First Posted (ESTIMATE): March 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 23, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Hypersensitivity; Allergy; Rhinoconjunctivitis; Grass pollen; Immune system disorder
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: BTT-gpASIT005