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

NCT ID: NCT01308021

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-12-31

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.

Conditions

Grass Pollen Allergy; Hay Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

gpASIT400

gpASIT+TM 400 µg

Group Type: EXPERIMENTAL

gpASIT+TM

Intervention Type: BIOLOGICAL

entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days

gpASIT800

gpASIT+TM 800 µg

Group Type: EXPERIMENTAL

gpASIT+TM

Intervention Type: BIOLOGICAL

entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo entero-coated capsules

Interventions

gpASIT+TM

entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days

Intervention Type: BIOLOGICAL

gpASIT+TM

entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days

Intervention Type: BIOLOGICAL

Placebo

Placebo entero-coated capsules

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioTech Tools S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claus Bachert, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Ghent

Jan Ceuppens, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Didier Ebo, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Antwerpen

Jean-Luc Halloy, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Warquignies

Stijn Hallewyck, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Peter Hellings, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Renaud Louis, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Liege

Catherine Mbasoa, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique du Parc Léopold Bruxelles

Charles Pilette, MD

Role: PRINCIPAL_INVESTIGATOR

UCL Saint Luc Bruxelles

Hélène Simonis, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Citadelle Liège

Olivier Vandenplas, MD

Role: PRINCIPAL_INVESTIGATOR

UCL Mont Godinne Yvoir

Christoph Verhoye, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Lucas Brugge

Patricia Wackenier, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Ambroise-Paré - Mons

Frédéric De Blay, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Strasbourg

Marie-Christine Castelain, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Vincent de Paul, Lille

François Lavaud, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Reims

Benoît Wallaert, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Lille

François Wessel, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice Nantes

Bruno Lebeaupin, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice Nantes

François Hentges, MD

Role: PRINCIPAL_INVESTIGATOR

CHL Luxembourg

François Durand Perdriel, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice Nantes

François Spirlet, MD

Role: PRINCIPAL_INVESTIGATOR

CH de Dinant

Locations

CHR Saint Joseph Warquignies

Boussu, , Belgium

AZ Sint Lucas

Bruges, , Belgium

Clinique du Parc Léopold

Brussels, , Belgium

UZ Brussel

Brussels, , Belgium

UCL Saint Luc

Brussels, , Belgium

UZ Antwerpen

Edegem, , Belgium

UZ Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

CHR Citadelle

Liège, , Belgium

CHU Sart-Tilman

Liège, , Belgium

CHU Ambroise Paré

Mons, , Belgium

UCL Mont Godinne

Yvoir, , Belgium

Hôpital Saint Vincent de Paul

Lille, , France

CHRU Lille

Lille, , France

Private practice

Nantes, , France

Private practice

Nantes, , France

CHU Reims

Reims, , France

CHRU Strasbourg

Strasbourg, , France

CH Luxembourg

Luxembourg, , Luxembourg

Countries

Belgium; France; Luxembourg

Other Identifiers

BTT-gpASIT005

Identifier Type: -

Identifier Source: org_study_id