A Phase III trial assessing the pharmacodynamic efficacy and the tolerability of Grazax® treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis - Grazax® in-seaso

Conditions: Grass pollen induced rhinoconjunctivitis
MedDRA version: 9.1Level: LLTClassification code 10039097Term: Rhinoconjunctivitis

Registration Number: EUCTR2007-006009-26-AT

Lead Sponsor: ALK-Abelló A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

- A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms, which remain troublesome despite treatment with anti-allergic drugs during the GPS of two years or more

- A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms during GPS causing symptoms more the 4 days per week (for > 4 weeks)

- A clinical history of significant persistent rhinoconjunctivitis symptoms during GPS causing least one of the a-d symptoms
a.Abnormal sleep
b.Impairment of daily activities, sports, leisure
c.Impaired work and school
d.Troublesome symptoms

- Positive specific IgE against Phleum pratense (= IgE Class 2)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Uncontrolled asthma in the past 12 months

- FEV1 < 70% of predicted value after adequate pharmacologic treatment

- Inflammatory condition in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis

- History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis

- History of facial angioedema in GPS or presence of facial angioedema at time of randomization

- History of swallowing difficulties in GPS or presence of swallowing difficulties at time of randomization

- History of allergy symptoms in the GPS leading to hospital admission

- History of allergy symptoms in the GPS leading to treatment with corticosteroids other than topical corticosteroids

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to investigate the pharmacodynamic efficacy of Grazax® compared to placebo when treatment is initiated during season, based on IgE blocking antibodies.;Secondary Objective: The secondary objectives of the trial are to investigate the pharmacodynamic efficacy of Grazax® compared to placebo when treatment is initiated during season, with respect to other immunological assessments and toevaluate the tolerability of Grazax® treatment compared to placebo when initiated during the grass pollen season.;Primary end point(s): To investigate the pharmacodynamic efficacy of Grazax® compared to placebo when treatment is initiated during season, based on IgE blocking antibodies (e.g to demonstrate a lower level of IgE blocking antibodies at visit 4 (approximately 8 weeks after treatment initiation) as compared to placebo)<br>

Secondary Outcome Measures

Name	Time	Method

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