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A Trial of Grazax in Subjects With Hayfever

A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00421655
Enrollment
329
Registered
2007-01-12
Start date
2006-12-31
Completion date
2007-10-31
Last updated
2015-06-24

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

Conditions

Allergy

Brief summary

The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.

Interventions

DRUGGrazax

Tablets 75,000 SQT and matching placebo. One tablet daily.

Sponsors

ALK-Abelló A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* History of grass pollen allergy * Positive skin prick test to grass * Positive specific IgE to grass

Exclusion criteria

* FEV1 \<70% of predicted value

Design outcomes

Primary

MeasureTime frame
Recording of allergy symptomsGrass pollen season 2007

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026