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
Trade Name: ALK-depot SQ 200 Gräsermischung und Roggen
Pharmaceutical Form: Injection*
Other descriptive name: 6 grass mix and rye pollen allergen
Concentration type: equal
Concentration number: 1.000
Sponsors
ALK-SCHERAX Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Male and female patients 18-65 years of age who have given informed consent, with the following selection criteria: • A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season • Positive Skin Prick Test (SPT) response to grass pollen Phleum pratense (wheal diameter = 3 mm) currently performed or not older than 60 days before V1 • If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the trial. 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: • Not controlled or severe bronchial asthma • Anamnestically known high degree of sensitivity against grass pollen • Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years • Autoimmune disorders • Exclusion criteria in accordance with contraindications in the SPC of Alutard SQ 6 grass mix + rye (secale) (= ALK-depot SQ Gräsermischung und Roggen).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to demonstrate the pharmacodynamic efficacy of specific immunotherapy with intraseasonal updosing compared to placebo in subjects with grass pollen induced rhinoconjunctivitis, based on IgX, i.e.: To demonstrate a lower level of IgX at Visit 9, approximately 9 weeks after start of updosing (i.e. approximately 2 weeks after the 8th injection), as compared to placebo. ;Secondary Objective: The secondary objectives of the trial are: ? To demonstrate the pharmacodynamic efficacy of specific immunotherapy with intraseasonal updosing compared to placebo with respect to 1. IgX measured at Visits 6 and 7 2. IgG4 measured at Visits 6, 7, and 9, i.e.: To demonstrate a lower level of IgX at Visits 6 and 7, approximately 1 and 3 weeks after start of updosing, as compared to placebo. AND To demonstrate a higher level of IgG4 at Visits 6, 7, and 9 approximately 1, 3, and 9 weeks after start of updosing, as compared to placebo. ? To demonstrate a lower nasal reactivity against challenge with Phleum pratense measured at study end with the titrated nasal provocation test as compared to placebo. ? To demonstrate a lower skin reactivity against challenge with Phleum pratense measured at study end with the titrated skin prick test as compared to placebo.;Primary end point(s): Immunological changes from baseline in spec. IgX against Phleum pratense after 9 weeks. | — |
Countries
Germany
Outcome results
None listed