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

Hay Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308021
• Other study ID #: BTT-gpASIT005
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2011
• Last updated: May 23, 2014
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2014
• Source: BioTech Tools S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Luxembourg: Ministère de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Conjunctivitis
• Grass Pollen Allergy
• Hay Fever
• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• gpASIT+TM
entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days
• gpASIT+TM
entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days
• Placebo
Placebo entero-coated capsules

Locations

Country	Name	City	State
Belgium	CHR Saint Joseph Warquignies	Boussu
Belgium	AZ Sint Lucas	Brugge
Belgium	Clinique du Parc Léopold	Brussels
Belgium	UCL Saint Luc	Brussels
Belgium	UZ Brussel	Brussels
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHR Citadelle	Liège
Belgium	CHU Sart-Tilman	Liège
Belgium	CHU Ambroise Paré	Mons
Belgium	UCL Mont Godinne	Yvoir
France	CHRU Lille	Lille
France	Hôpital Saint Vincent de Paul	Lille
France	Private practice	Nantes
France	Private practice	Nantes
France	CHU Reims	Reims
France	CHRU Strasbourg	Strasbourg
Luxembourg	CH Luxembourg	Luxembourg

Sponsors (1)

Lead Sponsor	Collaborator
BioTech Tools S.A.

Countries where clinical trial is conducted

Belgium,  France,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No