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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by BioTech Tools S.A..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
BioTech Tools S.A.
ClinicalTrials.gov Identifier:
NCT01308021
First received: February 28, 2011
Last updated: November 16, 2011
Last verified: November 2011

February 28, 2011
November 16, 2011
December 2010
October 2011   (final data collection date for primary outcome measure)
Impact of gpASIT+TM on the clinical efficacy of the subjects [ Time Frame: grass pollen season 2011 (April to July) ] [ Designated as safety issue: No ]
The following parameter will be assessed: rhinoconjunctivitis total symptom score
Same as current
Complete list of historical versions of study NCT01308021 on ClinicalTrials.gov Archive Site
  • Clinical tolerability and safety of the treatment [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011) ] [ Designated as safety issue: No ]
    The following parameter will be assessed: allergen-specific immunoglobulin concentrations
  • Impact of gpASIT+TM on the clinical status of the subjects [ Time Frame: grass pollen season 2011 (April-July) ] [ Designated as safety issue: No ]
    The average daily symptom and rescue medication scores will be assessed.
  • Impact of gpASIT+TM on the quality of life of the subjects [ Time Frame: grass pollen season 2011 (April-July) ] [ Designated as safety issue: No ]
    The quality of life will be assessed by the use of validated questionnaires.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Grass Pollen Allergy
  • Hay Fever
  • 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
  • Biological: Placebo
    Placebo entero-coated capsules
  • Experimental: gpASIT400
    gpASIT+TM 400 µg
    Intervention: Biological: gpASIT+TM
  • Experimental: gpASIT800
    gpASIT+TM 800 µg
    Intervention: Biological: gpASIT+TM
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
202
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Luxembourg
 
NCT01308021
BTT-gpASIT005
No
BioTech Tools S.A.
BioTech Tools S.A.
Not Provided
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 UZ Brussel
Principal Investigator: Peter Hellings, MD UZ Leuven
Principal Investigator: Renaud Louis, MD CHU Liège
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
BioTech Tools S.A.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP