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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00773240

Enrollment

276

Registered

2008-10-16

Start date

2008-04-30

Completion date

2009-02-28

Last updated

2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grass Pollen Allergy

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

Interventions

DRUGGrazax

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics - Immunological assessments	Pre- and post treatment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026