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

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

Study Overview

• Status: Completed
• Conditions: Grass Pollen Allergy
• Intervention / Treatment: Drug: Grazax; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Hørsholm, Denmark, DK-2970
    • ALK-Abello A/S, Bøge alle 6-8

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: placebo; 1 placebo tablet, matching the active treatment, daily during the trial period
EXPERIMENTAL: 1; Grazax	Drug: Grazax; 1 tablet, 75,000 SQ-T, daily during the trial period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamics - Immunological assessments	Pre- and post treatment

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S

Publications and helpful links

General Publications

• Reich K, Gessner C, Kroker A, Schwab JA, Pohl W, Villesen H, Wustenberg E, Emminger W. Immunologic effects and tolerability profile of in-season initiation of a standardized-quality grass allergy immunotherapy tablet: a phase III, multicenter, randomized, double-blind, placebo-controlled trial in adults with grass pollen-induced rhinoconjunctivitis. Clin Ther. 2011 Jul;33(7):828-40. doi: 10.1016/j.clinthera.2011.06.006. Epub 2011 Jul 7.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): October 1, 2008
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: October 15, 2008
• First Submitted That Met QC Criteria: October 15, 2008
• First Posted (ESTIMATE): October 16, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2011
• Last Update Submitted That Met QC Criteria: August 27, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: GT-18