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

Phase 2

Completed

• Conditions: Grass Pollen Allergy; Hay Fever
• Interventions: Biological: gpASIT+TM; Biological: Placebo

• Registration Number: NCT01308021
• Lead Sponsor: BioTech Tools S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-03
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-23
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gpASIT400	gpASIT+TM	gpASIT+TM 400 µg
gpASIT800	gpASIT+TM	gpASIT+TM 800 µg
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical tolerability and safety of the treatment	8 months	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)
Impact of gpASIT+TM on the immunological status of the subjects	screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011)	The following parameter will be assessed: allergen-specific immunoglobulin concentrations
Impact of gpASIT+TM on the clinical status of the subjects	grass pollen season 2011 (April-July)	The average daily symptom and rescue medication scores will be assessed.
Impact of gpASIT+TM on the quality of life of the subjects	grass pollen season 2011 (April-July)	The quality of life will be assessed by the use of validated questionnaires.

Trial Locations

Locations (18)

CHR Saint Joseph Warquignies; 🇧🇪 Boussu, Belgium

AZ Sint Lucas; 🇧🇪 Brugge, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

CHU Ambroise Paré; 🇧🇪 Mons, Belgium

Clinique du Parc Léopold; 🇧🇪 Brussels, Belgium

UCL Saint Luc; 🇧🇪 Brussels, Belgium

UZ Brussel; 🇧🇪 Brussels, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

UCL Mont Godinne; 🇧🇪 Yvoir, Belgium

CHRU Lille; 🇫🇷 Lille, France

CHR Citadelle; 🇧🇪 Liège, Belgium

CHU Sart-Tilman; 🇧🇪 Liège, Belgium

Hôpital Saint Vincent de Paul; 🇫🇷 Lille, France

Private practice; 🇫🇷 Nantes, France

CHU Reims; 🇫🇷 Reims, France

CHRU Strasbourg; 🇫🇷 Strasbourg, France

CH Luxembourg; 🇱🇺 Luxembourg, Luxembourg