A randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of PQ Birch in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by birch pollen exposure

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507427-28-00

Acronym

PQBirch302

Enrollment

562

Registered

2024-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

seasonal allergic rhinitis and/or rhinoconjunctivitis

Brief summary

CSMS averaged over the peak BPS.

Detailed description

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

DRUGPlacebo: 2% (w/v) L-tyrosine and 0.5% (w/v) phenol for subcutaneous use

DRUGPollinex Quattro Plus 1.0 mL Birch

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
CSMS averaged over the peak BPS.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

—

Countries

Austria, Germany, Poland

Outcome results

None listed

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