A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment

A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment Initiated in the Grass Pollen Season in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Sponsors

Lead Sponsor: ALK-Abelló A/S

Source ALK-Abelló A/S
Brief Summary

The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis

Overall Status Completed
Start Date April 2008
Completion Date February 2009
Primary Completion Date October 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Pharmacodynamics - Immunological assessments Pre- and post treatment
Enrollment 276
Condition
Intervention

Intervention Type: Drug

Intervention Name: Grazax

Description: 1 tablet, 75,000 SQ-T, daily during the trial period

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: placebo

Description: 1 placebo tablet, matching the active treatment, daily during the trial period

Arm Group Label: 2

Eligibility

Criteria:

Inclusion Criteria: - Positive skin prick test to Phleum pratense - Positive IgE to Phleum pratense - signed informed consent - A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms Exclusion Criteria: - No uncontrolled asthma in the past 12 months - No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension - No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension

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: ALK-Abello A/S, Bøge alle 6-8
Location Countries

Denmark

Verification Date

August 2011

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Description: Grazax

Label: 2

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov