Trials Sponsors Conditions Drugs Pricing

Conditions

Seasonal allergic rhinitis/rhinoconjunctivitis induced by grass pollen exposure

Outcome Measures

Primary Outcomes (2)

-Part A: The CSMS averaged over the peak GPS during Year 1.
-Part B: The CSMS averaged over the peak GPS after 2 years of treatment-free follow-up.

Secondary Outcomes (11)

Part A Efficacy: - The CSMS averaged over the entire (or truncated) GPS. - The dSS component of the CSMS averaged over the peak GPS. - The dMS component of the CSMS averaged over the peak GPS.
- The TCS averaged over the peak GPS. - The probability of well days and severe days during the peak GPS. - Serum grass specific IgG4 at Visit 11 compared to Part A Visit 1 (baseline). - Change from Part A Visit 2 (baseline) to Visit 11 in PRQLQ, AdolRQLQ and RQLQ(S) measured in selected countries.
Part A Safety: - Frequency, severity and relationship of AEs to treatment. - Frequency of AEs leading to premature discontinuation from treatment or trial. - Frequency of AESI.
- Changes in clinical laboratory values (serum chemistry, haematology, urinalysis) between screening and Visit 11. - Changes in vital signs (all subjects) and spirometry/PEFR (only in subjects with past or current asthma) at all treatment visits.
Part B Efficacy: Key secondary endpoints: - The CSMS averaged over the peak GPS after 3 years of treatment. - The TCS averaged over the peak GPS after 3 years of treatment. - The TCS averaged over the peak GPS after 2 years of treatment-free follow-up.
+6 more secondary outcomes

Interventions

PREDNISOLONEType not reported

Placebo with MCT, suspension for injection, subcutaneous useType not reported

LORATADINEType not reported

Registry intervention entries

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

Formulated product
PREDNISOLONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry record
Formulated product
LORATADINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry record
Formulated product
Bencard Prick-Testlösung Negativ-Kontrolle
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
DESLORATADINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM COATED TABLET
View registry record
Formulated product
PREDNISOLONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

Ingredients named in source formulations

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

PREDNISOLONE
Named ingredient: Prednisolone
View registry record
LORATADINE
Named ingredient: Loratadine
View registry record
Bencard Prick-Testlösung Negativ-Kontrolle
Named ingredient: Phenol
View registry record
DESLORATADINE
Named ingredient: desloratadine
View registry record
PREDNISOLONE
Named ingredient: Prednisolone
View registry record
Histamin-Kontrollösung 1% Pricktestlösung Wirkstoff: Histamindihydrochlorid
Named ingredient: Histamine dihydrochloride
View registry record
LORATADINE
Named ingredient: Loratadine
View registry record

Eligibility Criteria

Sexall

Age GroupsChild (0-17)

You may qualify if:

Written informed consent from a legal representative on the subject’s behalf (with/without assent depending on applicable country-specific regulations).
Subjects aged 4 to 16 years inclusive at the time of signing the consent (assent) form. The subject must be ≥5 to ≤16 years old at the first randomisation visit.

Sponsors & Collaborators

Allergy Therapeutics (UK) Limited
Industrylead

Study Sites (66)

Universitaetsklinikum Augsburg

Augsburg, 86156, Germany

Michael Gerstlauer00498214009218 michael.gerstlauer@uk-augsburg.de

Universitaetsmedizin Goettingen

Goettingen, 37075, Germany

Christiane Lex00495513966900 Christiane.lex@med.uni-goettingen.de

Philipps-Universitaet Marburg

Marburg, 35043, Germany

Oliver Pfaar004964215866933

Central Study Contacts

Clinical Research Management

+4407792037068 PQGrass308@allergytherapeutics.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

February 16, 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: 2023-508520-36-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:15:32 UTC

Documents

D1_Protocol_2023-508520-36_Redacted

You may not qualify if:

Pregnant or lactating subject.
Presence of any medical history of moderate to severe allergy symptoms, to any other seasonal allergen (other than grass) or perennial allergens, confirmed by a positive specific IgE [Class ≥2] at screening.
Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
History of any autoimmune disease or other immunological disorder or other diseases (including, but not limited to malignancy, cardiovascular, gastro-intestinal, hepatic, renal, haematological, neurological, psychiatric, endocrine or pulmonary disease) that in the opinion of the Investigator may pose a safety risk or compromise the interpretation of efficacy of the trial treatment.
Presence of severe or poorly controlled asthma as defined by current Global Initiative for Asthma (GINA) guidelines (current GINA) or requiring more than a daily dose above 800 μg (in adolescents) or 400 μg (in children) of inhaled budesonide [or equivalent inhaled corticosteroid].
Hospital admission for exacerbation of asthma in the 12 months prior to Visit 1 or any history of a life-threatening asthma attack.
Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
Presence of nasal polyps and/or chronic sinusitis.
Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis.
Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results.
Severe eczema with involvement of more than 25% of the body surface.
Clinical history of Type I diabetes. Subjects with well-controlled Type II diabetes will be allowed to participate at the discretion of the Investigator.
Any acute infection (including upper respiratory tract infections in the 7 days prior to Visit 2, which in the opinion of the investigator may pose a safety risk to the subject.
Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis
Clinical history of allergy, hypersensitivity or intolerance to the excipients of the trial medication.
+13 more criteria

Long-term clinical trial of PQ Grass in paediatric subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

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 (2)

Secondary Outcomes (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations