Safety and Tolerability Study of rBet v1 SLIT Tablets

Phase 1

Completed

• Conditions: Birch Pollen-Related Rhinoconjunctivitis; Rhinitis, Allergic, Seasonal

• Registration Number: NCT00889460
• Lead Sponsor: Stallergenes Greer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Last Update Submitted: 2009-04-28
• Study First Posted: 2009-04-29
• Last Update Posted: 2009-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local tolerability	Assessed every day over 2 weeks
Global safety	Assessed every day over 2 weeks

Secondary Outcome Measures

Name	Time	Method
Immunological markers (IgE and IgG4)	Between selection and follow-up visit (up to 18 weeks)

Trial Locations

Locations (1)

National University Hospital - Allergy Unit 4222; 🇩🇰 Copenhagen, Denmark