NCT00413556CompletedPhase 3
Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study Investigating Changes in Immunological Parameters and Cutaneous Reactivity Induced by a Short Course Immunotherapy With ALK Grass Tablets
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Difference in serum leves of IgG4
Study Overview
Brief Summary
We plan to determine changes in the immune system during the allergic response to grass pollen allergens. We have chosen a particular element of the immune response, the immunoglobulin G4 (IgG4) as an indicator.
We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE mediated) and late (cell mediated) allergic response.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A history of grass pollen allergy
- •Positive skin prick test to grass
- •Positive specific IgE to grass
Exclusion Criteria
- •Treatment with anti-IgE
Arms & Interventions
1
Active Comparator
Intervention: ALK Grass tablet (Biological)
2
Placebo Comparator
Intervention: ALK Grass tablet (Biological)
Outcomes
Primary Outcomes
Difference in serum leves of IgG4
Time Frame: 6 months
Secondary Outcomes
- Changes in IgE level(6 months)
- Changes in cutaneous response(6 months)
Investigators
Study Sites (1)
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