Grass pollen induced allergic rhinoconjunctivitis requiring treatment during the grass pollen season MedDRA version: 9.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis
Conditions
Interventions
Product Name: ALK-Flex SQ
Pharmaceutical Form: Injection*
Other descriptive name: 4 grass mix and rye pollen allergens
Concentration unit: SQU/ml Standardised Quality Unit(s)/millilitre (Deprecated)
C
Sponsors
ALK-Abelló Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season Lack of adequate relief with symptomatic medication during the previous pollen season Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter = 3 mm) currently performed or not older than 60 days before screening. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: FEV1 < 70% of predicted value at screening Bronchial asthma corresponding to GINA step 3 or more, even if controlled History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ 4 grass mix + rye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of two updosing schedules with respect to the pharmacodynamic efficacy regarding changes from baseline in spec. IgE-blocking factor against Phleum pratense after seven injections of the IMP (ALK-Flex SQ);Primary end point(s): Changes from baseline in specific IgE-blocking factor measured 1 week after the 7th injection will be the only primary endpoint of this study. Equivalence of the updosing schedules Group 1 and Group 2 will be tested with a prespecified equivalence margin.;Secondary Objective: To compare both groups with respect to incidences of delayed systemic adverse events (1-24 hrs) in Group 1 and Group 2 classified as 'urticaria' and/or 'asthma' according to EAACI. To compare both groups with respect to incidences of early adverse events (0-60 min) in Group 1 and Group 2, graduated according to EAACI and classified according to MedDRA version 11.0. To compare both groups with respect to changes from baseline in spec. IgG4 against Phleum pratense 1 week after the 7th injection of the IMP (ALK-Flex SQ). To compare both groups with respect to changes from baseline in spec. IgE against Phleum pratense 1 week after the 7th injection of the IMP (ALK-Flex SQ). | — |
Countries
Germany
Outcome results
None listed