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

Primary Purpose

Grass Pollen Allergy

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Grazax

placebo

About this trial

This is an interventional treatment trial for Grass Pollen Allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ALK-Abello A/S, Bøge alle 6-8

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Grazax

Outcomes

Primary Outcome Measures

Pharmacodynamics - Immunological assessments

Secondary Outcome Measures

Full Information

NCT ID

NCT00773240

First Posted

October 15, 2008

Last Updated

August 27, 2011

Sponsor

ALK-Abelló A/S

1. Study Identification

Unique Protocol Identification Number

NCT00773240

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ALK-Abelló A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Grass Pollen Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

276 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Grazax

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Grazax

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacodynamics - Immunological assessments

Time Frame

Pre- and post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kim Simonsen, MD

Organizational Affiliation

ALK-Abelló A/S

Official's Role

Study Director

Facility Information:

Facility Name

ALK-Abello A/S, Bøge alle 6-8

City

Hørsholm

ZIP/Postal Code

DK-2970

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

21741092

Citation

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.

Results Reference

derived

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

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