Safety and Tolerability Study of Ragweed SLIT Tablets

Stallergenes Greer

Status and phase

Completed

Phase 1

Conditions

Ragweed Pollen Allergy

Rhinitis, Allergic, Seasonal

Treatments

Drug: Sublingual tablet of ragweed pollen allergen extract

Study type

Interventional

Funder types

Industry

Identifiers

NCT01224834

VO63.08 HUN

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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