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Changes in the Immune Response and Skin Reactivity of Grass Pollen Allergic Patients Treated With ALK Grass Tablets

A

ALK-Abelló

Status and phase

Completed
Phase 3

Conditions

Allergy

Treatments

Biological: ALK Grass tablet

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

76 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Treatment:
Biological: ALK Grass tablet
2
Placebo Comparator group
Treatment:
Biological: ALK Grass tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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