Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

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

NCT00396149

VO49.06 DK

Details and patient eligibility

About

To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.

Enrollment: 57 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written consent
• 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) of at least Class 2 at screening.
• FEV1 at least of 80% of predicted values at screening.

Exclusion criteria

• Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder...) or who plan to start desensitization treatment during this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo group

Treatment:

Biological: Placebo

Active group

Experimental group

Description:

rBet v 1 tablets

Treatment:

Biological: rBet v 1