Safety and Tolerability Study of Ragweed SLIT Tablets

Phase 1

Completed

• Conditions: Rhinitis, Allergic, Seasonal; Ragweed Pollen Allergy
• Interventions: Drug: Sublingual tablet of ragweed pollen allergen extract

• Registration Number: NCT01224834
• Lead Sponsor: Stallergenes Greer

Brief Summary

The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-04
• Study Completion: 2009-10
• Status Verified: 2010-10
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Submitted: 2010-11-05
• Last Update Posted: 2010-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• written consent
• male or female subjects from 18 yo 60 years old and in general good health
• for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
• symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
• sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening
• FEV1 at least of 80% of predicted value at screening

Exclusion Criteria

• past or current disease which, as judged by the investigator, may affect the outcome of this study
• history of life-threatening asthma
• asthma requiring daily treatment (whatever the pharmaceutical class)
• pregnant or lactating women
• subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study
• symptoms during the treatment phase due to a sensitivity to a second allergen
• subjects treated with ongoing immunotherapy with another allergen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sublingual tablet of ragweed pollen allergen extract	-
2	Sublingual tablet of ragweed pollen allergen extract	-

Primary Outcome Measures

Name	Time	Method
Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks	2 weeks

Secondary Outcome Measures

Name	Time	Method
Immunological markers (IgE and IgG4)	2 weeks

Trial Locations

Locations (1)

DRC Drug Research Center; 🇭🇺 Balatonfüred, Hungary