NCT01694836

Depigoid Birch 5000 Longterm Study in Adults and Adolescents

Multicenter, Placebo-controlled, Long-term Study of Depigoid Birch 5000 in Adults and Adolescents With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 634 (actual)
• Sponsor: Leti Pharma GmbH · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Specific immunotherapy for IgE mediated sensitization to birch pollen. Long-term study to assess safety and efficacy of Depigoid(R)Birch 5000 - a modified pollen extract of Betula alba (Birch) - versus placebo.

Detailed description

Investigation of the long-term efficacy and safety of Depigoid Birch 5000 according to the perennial treatment regimen in comparison to placebo in adult and adolescent patients with birch pollen-induced allergic rhinitis and/or rhinoconjunctivitis to show superiority vs. placebo. As the study includes adolescent patients it is run under an approved PIP. Total study duration per patient will be 5 years: 3 years of perennial treatment (application of study medication at intervals of 4-6 weeks) followed by a treatment-free observational phase of 2 years (seasons).

Conditions

• Allergic Rhinitis/Rhinoconjunctivitis +-Intermittent Asthma
• Sensitization Against Betula Alba (Birch) Pollen

Interventions

Type	Name	Description
BIOLOGICAL	s.c. injection	3 years of therapy followed by 2 years (seasons) of treatment-free observational period

Timeline

• Start date: 2012-09-17
• Primary completion: 2018-07-30
• Completion: 2018-07-30
• First posted: 2012-09-27
• Last updated: 2019-01-16

Locations

2 sites across 1 country: Germany