NCT04912076

S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen

A Randomized, DBPC Study to Determine the Safety, Tolerability and Immunological Effects of BM41 Compared to Placebo and to Treatment With Standard s.c. Immunotherapy in Patients Allergic to Birch Pollen

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical phase I single centre, randomized, double-blind, placebo-controlled study with open comparator is to investigate tolerability and safety as well as the immunological effects of BM41 in comparison to placebo (double blind) and to a standard subcutaneous immunotherapy Alutard SQ (open) in birch allergic patients.

Detailed description

Please see original article.

Conditions

• Birch Pollen Allergy
• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	BM41	Subcutaneous injection of increasing doses of BM41
OTHER	Placebo	Subcutaneous injections of placebo containing aluminium hydroxide.
DRUG	ALK Alutard SQ Betula verrucosa	Subcutaneous injections with increasing doses of Alutard according to cluster up-dosing scheme.

Timeline

• Start date: 2018-09-17
• Primary completion: 2019-03-22
• Completion: 2019-03-22
• First posted: 2021-06-03
• Last updated: 2023-12-11

Locations

1 site across 1 country: Denmark