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Completed

NCT Number: NCT00773240

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

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

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Key information

Conditions

Grass Pollen Allergy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ALK-Abello A/S, Bøge alle 6-8

Hørsholm, DK-2970, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GRAZAX

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Pharmacodynamics - Immunological assessments

    Time frame: Pre- and post treatment

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Oct 16, 2008
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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