A prospective, randomized, double-blind placebo-controlled multicentre study with mannan-conjugated birch pollen allergoids administered subcutaneously to adolescent and adult patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508013-16-00

Acronym

T502-SIT-068

Enrollment

600

Registered

2024-02-14

Start date

2024-02-26

Completion date

2024-06-28

Last updated

2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birch pollen induced allergic rhinitis or rhinoconjunctivitis

Brief summary

The clinical impact of T502 treatment will be assessed by comparing the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2024 between the placebo and the active treatment group.

Interventions

DRUGplacebo will be identical in appearance to the investigational medicinal product

DRUGMannan-conjugated allergoid (polymerized) Betula pendula parenteral vaccine

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The clinical impact of T502 treatment will be assessed by comparing the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2024 between the placebo and the active treatment group.	—

Countries

Germany, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026