A Trial of the ALK Grass Tablet in Subjects With Hayfever

A Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of ALK Grass Tablet in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00227279

Enrollment

634

Registered

2005-09-28

Start date

2004-10-31

Completion date

2009-09-30

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Grass pollen allergy, Hayfever, Allergen immunotherapy, Specific immunotherapy

Brief summary

This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).

Interventions

BIOLOGICALALK Grass tablet

Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Eligibility Criteria: * A history of grass pollen induced rhinoconjunctivitis * Positive skin prick test to grass * Positive specific IgE to grass

Design outcomes

Primary

Measure	Time frame
Recording of rhinoconjunctivitis symptoms	Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009
Recording of use of rescue medication	Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009

Secondary

Measure	Time frame
Quality of life	Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026