Treatment of seasonal grass pollen rhinoconjunctivitis MedDRA version: 14.1 Level: LLT Classification code 10019170 Term: Hay fever System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: gpASIT+™
Pharmaceutical Form: Injection
Other descriptive name: pollen peptides (400 µg/mL)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 400-
Prod
Sponsors
BioTech Tools S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject has given written informed consent • Age between 18 and 50 years • 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 • Females 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 diagnosis: o A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years o A positive skin prick test (wheal diameter = 3 mm) to grass-pollen mixture o Specific IgE against grass pollen (IgE > 0.7 kU/l) [using recombinant mixture of rPhl p1 and rPhl p5b Phleum pratense (g213)] • Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2009 and who had as well moderate to severe symptoms in the two previous years (2010 and 2011) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects with current immunotherapy and subjects who underwent a previous immunotherapy within the last 2 years • Participation in another clinical trial and/or treatment with an experimental drug within the last 3 months • A history of hypersensitivity to the excipients of investigational products • Subjects with perennial asthma (regular intake of inhaled corticosteroids outside the pollen season: consumption on a daily base or patients who are taking a reliever more than twice a week) • Subjects with severe seasonal asthma requiring long acting beta agonist AND inhaled steroid treatment • Subjects with a VC 37.5°C, oral) • A known positive serology for HIV-1/2, HBV or HCV • Subjects that are immunocompromised by medication or illness, have 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 • Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (e.g. OCs, IUD, V-rings and contraceptive implants, condoms…) • 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 • Subjects without means of contacting the Investigator rapidly in case of emergency, or not able to be contacted rapidly by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • The primary objective of this clinical trial in patients suffering from hay fever is the assessment of the safety and clinical tolerability of gpASIT+™ when administered by subcutaneous injection alone or with DnaK, an immunoregulating adjuvant, until the end of the grass pollen season (Visit 10, July 2012).;Secondary Objective: • The secondary objective of this trial are: - the assessment of the immunogenicity of gpASIT+™ administered subcutaneously alone or in the presence of DnaK as adjuvant. - the assessment of the adjuvant effect of DnaK on reduction of symptom scores and rescue medication intake and on improvement of the quality of life of the subjects during the subsequent grass pollen season. - the evolution of immunological, inflammatory and grass pollen- and DnaK-specific immunoglobulins during a 12-month follow-up period (from baseline to Visit 11, January 2013);Primary end point(s): The possible adverse reactions will be investigated by the systematic recording at predetermined time points of • general physical status, vital signs (heart rate and blood pressure), • solicited local adverse events (reactions at the injection site), unsolicited adverse events, serious adverse events, • haematological parameters (haemoglobin, haematocrit, Red Blood Cell (RBC), White Blood Cells (WBC) including differential counts and platelets), • routine blood biochemistry parameters, • DnaK-specific immunoglobulins analysis, • immunological analysis (total IgE and IgG levels, anti-nuclear antibodies (ANA) and Rheumatoid Factor (RF)), • inflammatory parameters (C-Reactive protein (CRP)), • DnaK-specific IgG. • urinalysis,;Timepoint(s) of evaluation of this end point: - Physical status, vital sign : Visit 1 to 10; - Solicited local adverse events : all visits during treatment (Visit 2 to 6); - Unsolicited adverse events: from Visit 2 to 10; - Serious adverse events : from Visit 2 to 11; - Blood analysis for safety assessment (haematology, routine bioche | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective of the trial are: • The monitoring of the changes in grass pollen allergen-specific IgE, IgG, IgG4, IgA antibody concentrations in gpASIT+TM treated and gpASIT+TM / DnaK treated subjects. This will be analyzed first from baseline to the end of the grass pollen season. A second analysis will cover a 12-month reporting period. • The adjuvant effect of DnaK on the reduction of symptom scores and the rescue medication intake and on the improvement of the quality of life of the subjects assessed by recording on diary cards, the daily allergic symptom score, the daily rescue medication intake during the pollen season following treatment and by answering a validated rhinoconjunctivitis quality-of-life questionnaire (RQLQ). • As exploratory endpoints, the production of DnaK-specific IgE, IgA and IgM and the characterization of the different isotypes of DnaK-specific IgG (IgG1 to IgG4). The production of blocking antibodies will as well be assessed in the serum of the gpASIT+TM / DnaK treated subjects in comparison with gpASIT+TM treated subjects. ;Timepoint(s) of evaluation of this end point: Visit 1, Visit 7, Visit 8 and at Visit 10 in a first analysis: determination of grass pollen specific IgE, IgG, IgG4, IgA and blocking antibodies and the production of DnaK-specific IgE, IgA and IgM and the characterization of the different isotypes of DnaK-specific IgG (IgG1 to IgG4) (exploratory). Visit 1, Visit 7, Visit 8, Visit 10 and Visit 11 in a second analysis: same determination as described in the first analysis. During (V9) and after the pollen season (V10):Symptom/ Rescue Medication Diary cards + Quality-of-Life Questionnaire | — |
Countries
Belgium
Contacts
Public ContactMarc Thomson
Medical Sigma
Outcome results
None listed