NCT02481856

A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber

A Dose-response Evaluation of the SQ Tree SLIT-tablet in Subjects With Moderate to Severe Allergic Rhinoconjunctivitis Induced by Pollens From the Birch Group During Controlled Exposure in an Environmental Exposure Chamber

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled multi-site trial conducted in Canada. Before the start of treatment, the subjects will undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after 24 weeks of treatment.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	SQ tree SLIT-tablet
DRUG	Placebo

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-06-25
• Last updated: 2017-01-19

Locations

1 site across 1 country: Canada