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

NCT04912076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-12-11

No results posted yet for this study

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.

Conditions

  • Birch Pollen Allergy
  • Allergic Rhinoconjunctivitis

Interventions

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.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Biomay AG

    collaborator INDUSTRY

  • European Commission

    collaborator OTHER

  • University of Salzburg

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Carsten Bindslev-Jensen, Professor · Odense research Center for Anaphylaxis, Odense University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2019-03-22
Completion
2019-03-22

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912076 on ClinicalTrials.gov