Trials Sponsors Conditions Drugs Pricing

Conditions

birch pollen-induced allergic rhinitis birch pollen-induced allergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

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

EMADINE 0.5 mg/ml, eye drops, solutionType not reported

AVAMYS 27.5 micrograms/spray, nasal spray suspensionType not reported

ALK Prick Positiv Kontrolle - Lösung für Haut-PricktestType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
AVAMYS 27.5 micrograms/spray, nasal spray suspension
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
NASAL SPRAY, SUSPENSION
View registry record
Formulated product
ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR SKIN-PRICK TEST
View registry record
Formulated product
Loratadin-ratiopharm® 10 mg Tabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry record
Formulated product
Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
NASAL SPRAY, SUSPENSION
View registry record
Formulated product

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

AVAMYS 27.5 micrograms/spray, nasal spray suspension
Named ingredient: fluticasone furoate
View registry record
ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest
Named ingredient: Histamine dihydrochloride
View registry record
Loratadin-ratiopharm® 10 mg Tabletten
Named ingredient: Loratadine
View registry record
Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension
Named ingredient: Budesonide
View registry record
Alvesco 160 Mikrogramm Druckgasinhalation, Lösung
Named ingredient: ciclesonide
View registry record
Histamin-Kontrollösung 1% Pricktestlösung Wirkstoff: Histamindihydrochlorid
Named ingredient: Histamine dihydrochloride
View registry record

Eligibility Criteria

Sexall

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

You may qualify if:

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

Sponsors & Collaborators

Inmunotek S.L.
Industrylead

Study Sites (23)

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

Marburg, 35043, Germany

Oliver Pfaar+4964215865617 oliver@pfaar.org

HNO Praxis Dresden Dr. med. Udo Schäfer

Dresden, 01067, Germany

Udo Schäfer+4935132010160 schaefer@hno-praxis-dresden.de

Praxis Dr. Jörg Winkler Pneumologisches Studienzentrum

Leipzig, 04103, Germany

Jörg Winkler

Central Study Contacts

Miguel Casanovas

+34691490175 mcasanovas@inmunotek.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

July 22, 2024

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: 2024-515717-17-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 05:24:36 UTC

Documents

D4_Patient facing documents_Treatment Diary_redacted

You may not qualify if:

Previous immunotherapy with birch pollen allergens within the last 5 years.
Ongoing immunotherapy with birch pollen allergens or any other allergens
Participants with acute allergic rhinitis or rhinoconjunctivitis due to other environmental allergens during the trial period.
Being in any relationship or dependence with the Sponsor, CRO and/or Investigator.
Inability to understand instructions/trial documents.
Participants for whom the Investigator believes that they will not comply with the protocol (participants with known alcohol or drug abuse or with a history of a serious psychiatric disorder as well as participants unwilling to give informed consent or to abide by the requirements of the protocol).
Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
Participants who do not have access to a smartphone/tablet (iOS or Android, in exceptional cases, a paper diary may be issued if installation on the mobile device is not technically possible).
History of systemic reactions and/or anaphylaxis (Grade III or IV according to the AWMF guideline 2021), including to food (e.g., peanut, marine animals) or to Hymenoptera venom (e.g., bee, wasp stings) or to medication (e.g., penicillin), etc.
History of hypersensitivity to the excipients of the investigational product or placebo.
Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2023) during the treatment period.
Chronic asthma or emphysema, particularly with a Forced Expiratory Volume in 1 second (FEV1) <80% of the participant’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the participants’ individual optimal value measured at the screening visit.
Previous or ongoing respiratory tract infection (e.g., flu, COVID-19) and/or exacerbation of asthma within 4 weeks before the screening visit.
History of significant renal disease or chronic hepatic disease.
Malignant active disease (ongoing or within the five past years).
+14 more criteria

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.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

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.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations