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Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma

NCT05668390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 553

Last updated 2025-11-26

No results posted yet for this study

Summary

Allergic rhinoconjunctivitis due to birch pollen is a seasonal problem which manifests as a combination of nasal symptoms (such as congestion, runny nose, sneezing, itching of the nose) and ocular symptoms (such as red, itchy and watery eyes). For several birch-allergic patients, allergic rhinoconjunctivitis occurs with an oral allergy syndrome.

The purpose of this study is to demonstrate the safety and efficacy of the study drug (STALORAL Birch 300 IR) in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis, with or without asthma, when treated before and during the pollen season.

Approximately 699 children will participate in this study. The study will be conducted worldwide in approximately 80 medical sites in about 12 countries. The total duration of the study will be approximately 20 months.

Conditions

  • Allergic Rhinoconjunctivitis
  • Birch Pollen Allergy

Interventions

DRUG

STALORAL® Birch 300 IR

2 treatment periods will consist of 2 steps: an escalation phase, where the treatment dose will gradually increase, followed by a maintenance phase.

Sponsors & Collaborators

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Oliver Pfarr, MD · Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2025-08-06
Completion
2025-08-06

Countries

  • Austria
  • Bulgaria
  • Finland
  • France
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovakia
  • Sweden

Study Locations

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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 NCT05668390 on ClinicalTrials.gov