Trials Sponsors Conditions Drugs Pricing

Conditions

Birch pollen induced allergic rhinitis or rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

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

placebo will be identical in appearance to the investigational medicinal productType not reported

Mannan-conjugated allergoid (polymerized) Betula pendula parenteral vaccineType not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Child (0-17)

You may qualify if:

Signed and dated Informed Consent Form a. by a legally competent participant, b. For adolescents: self-completed (signed and dated) participant informed consent to participate in the trial and signed and dated Informed Consent Form by both parents/legal guardian(s)
Patients aged from 12 to 64 years (at least 10% of the population should be 12-17 years of age (valid for Poland) OR patients aged from 18-64 years (valid for Germany)

Sponsors & Collaborators

CCDRD Cooperative Clinical Drug Research and Development AG
Industrylead
Inmunotek S.L.
Industryco_sponsor
ClinCompetence Cologne GmbH

Study Sites (54)

MVZ DermaKiel GmbH

Kiel, 24148, Germany

Harald Brüning+49431726065 stud.dr.h.bruening@gmx.de

HNO-Praxis Dr. El-Naib

Chemnitz, 09130, Germany

Petra El Naib+493714028359 petra.elnaib@web.de

Universitätsklinikum Marburg, Abtlg. f. HNO-Heilkunde, Kopf- Halschirurgie, Sektion Rhinolog

Marburg, 35043, Germany

Oliver Pfaar+4964215865617

Central Study Contacts

Medical Director

+34691490175 mcasanovas@inmunotek.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

October 13, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-508013-16-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-29 06:13:04 UTC

Documents

Summary CT laypersons V1-0 EN

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.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (54)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (54)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations