Safety and Tolerability Study of rBet v1 SLIT Tablets

Stallergenes Greer

Status and phase

Completed

Phase 1

Conditions

Birch Pollen-Related Rhinoconjunctivitis

Rhinitis, Allergic, Seasonal

Treatments

Biological: Placebo

Biological: rBet v 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00889460

VO58.07 DK

Details and patient eligibility

About

The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.

Enrollment

55 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

written consent
Male or female subject from 18 to 60 years old and in general good health
For woman of child bearing potential:
Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) >0.70 kU/L at screening.
FEV1 at least of 80% of predicted values at screening.
Subject accepting to comply fully with the protocol.

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 woman.
Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) 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