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

Sponsors

Lead Sponsor: ALK-Abelló A/S

Source ALK-Abelló A/S
Brief Summary

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

Overall Status Completed
Start Date December 2006
Completion Date October 2007
Primary Completion Date August 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Recording of allergy symptoms Grass pollen season 2007
Enrollment 329
Condition
Intervention

Intervention Type: Drug

Intervention Name: Grazax

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

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Kim Simonsen, MD Study Director ALK-Abelló A/S
Location
Facility: CompleWare Corporation
Location Countries

United States

Verification Date

June 2015

Responsible Party

Name Title: Kim Simonsen, MD, Senior Director

Organization: ALK-Abello

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Label: 2

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov