NCT00773240

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

6 months

First QC Date

October 15, 2008

Last Update Submit

August 27, 2011

Conditions

Grass Pollen Allergy

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamics - Immunological assessments

    Pre- and post treatment

Study Arms (2)

1

EXPERIMENTAL

Grazax

Drug: Grazax

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

GrazaxDRUG

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

1
placeboDRUG

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

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ALK-Abello A/S, Bøge alle 6-8

Hørsholm, DK-2970, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 21741092DERIVED

MeSH Terms

Interventions

Grazax

Study Officials

  • Kim Simonsen, MD

    ALK-Abelló A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2008

Study Completion

February 1, 2009

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

DK(1)