Trials Sponsors Conditions Drugs Pricing

Conditions

seasonal allergic rhinitis and/or rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

CSMS averaged over the peak BPS.

Secondary Outcomes (3)

Secondary Efficacy: - CSMS averaged over the entire BPS. - The dSS component of the CSMS averaged over the peak BPS. - The dMS component of the CSMS averaged over the peak BPS. - The TCS averaged over the peak BPS. - CSMS averaged over the combined peak seasons for alder, hazel, birch and oak pollen season (peak TPS). - RQLQ(S) measured at Visit 11.
- Serum birch-specific IgG4 at pre-BPS (Visit 9) compared to baseline.
Safety: - Frequency, severity and relationship of AEs to treatment. - Frequency of AEs leading to premature discontinuation from treatment or clinical trial. - Changes in clinical laboratory values (serum chemistry, haematology and urinalysis) between screening and Visit 12. - Changes in vital signs at all treatment visits.

Interventions

Placebo: 2% (w/v) L-tyrosine and 0.5% (w/v) phenol for subcutaneous useType not reported

Pollinex Quattro Plus 1.0 mL BirchType not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this clinical trial protocol and to attend required clinical trial visits.
Subject who has a signed and dated ICF.

Sponsors & Collaborators

Allergy Therapeutics (UK) Limited
Industrylead

Study Sites (58)

Aaki GmbH & Co. KG

Vienna, 1100, Austria

Gunter Sturm00436767070804 gunter.sturm@allamb.at

Ordensklinikum Linz GmbH

Linz, 4020, Austria

Barbara Ebner004373276764526 barbara.ebner@ordensklinikum.at

Allgemein Oeffentliches Bezirkskrankenhaus Kufstein

Kufstein, 6330, Austria

Thomas Taxacher004353726966391

Central Study Contacts

Clinical Research Management

+4407792037068 pqbirch302@allergytherapeutics.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

June 27, 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: 2023-507427-28-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:05:42 UTC

Documents

D1_Protocol_2023-507427-28_redacted

You may not qualify if:

Pregnant or lactating subject.
Presence of any medical history of moderate to severe allergy symptoms.
Moderate to severe symptoms during the 3 years prior to Visit 1 to any other seasonal or perennial allergen not tested in the sIgE measurements done at screening that cannot be avoided during Period 1 to Period 3 of the clinical trial and the symptoms of which may interfere with administration of treatment and/or impact the data collected.
Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
Presence of active systemic autoimmune disorder, systemic autoimmune disorders in remission or active organ specific autoimmune disorder.
Presence of active malignant neoplasia, severe cardiovascular disease (e.g., coronary artery disease, cardiac insufficiency, etc.), pulmonary insufficiency, severe psychiatric disorders or primary and secondary immunodeficiencies.
History of any other immunological disorder or other diseases (including, but not limited to cardiovascular [including uncontrolled or inadequately controlled hypertension], gastro-intestinal, hepatic, renal, haematological, neurological, endocrine or pulmonary disease) that in the opinion of the Investigator may pose a safety risk or compromise the interpretation of efficacy of the clinical trial treatment.
Presence of severe or poorly controlled or uncontrolled asthma as defined in the protocol.
Presence of non-atopic rhinitis.
Presence of chronic rhino-sinusitis. Chronic rhino-sinusitis will be diagnosed when at least two of the following four symptoms are present and occur for more than 12 weeks: (1) purulent drainage, (2) facial and/or dental pain, (3) nasal obstruction, (4) hyposmia.
Presence of nasal polyps.
Eye surgery within the past 6 months.
Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results.
Clinical history of Type I diabetes or poorly controlled Type II diabetes.
Moderate to severe upper or lower respiratory infections requiring medication within 14 days before Visit 1.
+25 more criteria

Randomised efficacy and safety clinical trial of PQ Birch in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by birch pollen.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (58)

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)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (58)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations