Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Phase 3

Completed

• Conditions: Rhinoconjunctivitis
• Interventions: Biological: AL0704rP; Biological: Placebo

• Registration Number: NCT00671268
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-05
• Primary Completion: 2012-03
• Study Completion: 2013-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• Allergic rhinoconjunctivitis attributable to grass pollen
• Positive SPT
• Positive EAST
• Positive provocation test

Exclusion Criteria

• serious disease
• other perennial allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AL0704rP	strict subcutaneous
2	Placebo	strict subcutaneous

Primary Outcome Measures

Name	Time	Method
Change of Symptom and Medication score	during the baseline and the following two pollen seasons

Trial Locations

Locations (1)

Allergopharma GmbH & Co. KG; 🇩🇪 Reinbek, Germany