drugset / Trial / NCT04912076
S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen
Phase 1
Completed
47 enrolled
Odense University Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabBiomay AG · collabEuropean Commission · collabUniversity of Salzburg · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-09-17
- Primary completion
- 2019-03-22
- Completion
- 2019-03-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ALK Alutard SQ Betula verrucosa | Unknown | 100000 unknown | Subcutaneous |
| Subject | BM41 | Unknown | 20 ug | Subcutaneous |