A prospective, randomized, double-blind placebo-controlled multicentre trial with mannan-conjugated birch pollen allergoids administered subcutaneously to adolescents and adults with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515717-17-00

Acronym

T502-SIT-073

Enrollment

360

Registered

2024-10-17

Start date

2024-10-28

Completion date

2025-06-27

Last updated

2025-08-07

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 birch pollen-induced allergic rhinoconjunctivitis

Brief summary

The clinical impact of T502 treatment will be assessed by comparing the mean daily Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2025 between the placebo and the active treatment group.

Interventions

DRUGEMADINE 0.5 mg/ml

DRUGeye drops

DRUGsolution

DRUGAVAMYS 27.5 micrograms/spray

DRUGnasal spray suspension

DRUGRupatadin AL 10 mg Tabletten

DRUGHAL Allergy Prick Test Hundeepithelien

DRUGMometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray

DRUGSuspension

DRUGALLERGOPHARMA HISTAMIN 1 + 999 zur Positivkontrolle beim Prick-Test Pricktestlösung zur Anwendung bei Kindern oder Erwachsenen

DRUGFlutica-Teva® 50 Mikrogramm Nasenspray

DRUGEbastin Aristo 10 mg Filmtabletten

DRUGDesloratadin Glenmark 5 mg Tabletten

DRUGPlacebo will be identical in appearance to the investigational medicinal product.

DRUGALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

DRUGMannan-conjugated allergoid (polymerized) Betula pendula parenteral vaccine

DRUGCetirizin-ratiopharm® bei Allergien Filmtabletten Wirkstoff: Cetirizindihydrochlorid 10 mg

DRUGLoratadin-ratiopharm® 10 mg Tabletten

DRUGBudes 64 Mikrogramm/Sprühstoß Nasenspray

DRUGAlvesco 160 Mikrogramm Druckgasinhalation

DRUGLösung

DRUGHistamin-Kontrollösung 1% Pricktestlösung Wirkstoff: Histamindihydrochlorid

DRUGNASACORT 55 Mikrogramm/Dosis Nasenspray

DRUGOlopatadin Micro Labs 1 mg/ml Augentropfen

DRUGHAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus

DRUGLivocab® direkt Augentropfen 0

DRUG05 % Augentropfen

DRUGHAL Allergy Prick Test Katzenepithelien

DRUGHAL Allergy Prick Test Birke

DRUGAllegra Allergietabletten 20 mg Tabletten

DRUGFexofenadin Winthrop 180 mg Filmtabletten

DRUGBilaxten 6 mg/ml Augentropfen

DRUGPrick Test Histamin LETI Positivkontrolle 10 mg/ml Pricktestlösung

DRUGLevocetirizin-ratiopharm 5 mg Filmtabletten

DRUGAzelastin COMOD 0

DRUG5 mg/ml Augentropfen

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 mean daily Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2025 between the placebo and the active treatment group.	—

Countries

Germany

Outcome results

None listed

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