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A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy of PURETHAL Mites Mixture 50,000 AUeq/mL Subcutaneous Immunotherapy in Adult Subjects with Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis with or without Asthma Induced by House Dust Mite (HDM) Allergy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504942-75-01
Acronym
PM/0059
Enrollment
582
Registered
2024-01-11
Start date
2024-08-22
Completion date
Unknown
Last updated
2025-12-16

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

Conditions

Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis with or without Asthma Induced by House Dust Mite (HDM) Allergy

Brief summary

Average daily TCRS during the last 8 weeks of treatment.

Detailed description

Average daily TNSS during the last 8 weeks of treatment., Average daily RMS during the last 8 weeks of treatment., Average daily TCCS during the last 8 weeks of treatment., Change from baseline in NPT (Lebel score) at the end of treatment., Change from baseline in IgE, IgG, IgG4 levels against D. pter and D. far at the end of treatment., RQLQ(S) at the end of treatment., Safety and tolerability during the entire treatment period assessed by treatment-related adverse events, local and systemic reactions., Safety of the treatment on asthma parameters assessed by asthma-related concomitant medication use, asthma related adverse events and lung function tests.

Interventions

DRUGPURETHAL Mites 50.000 AUeq/mL
DRUGHAL Allergy Prick Test Gemeiner Beifuß
DRUGHAL Allergy Pricktest Negativkontrolle
DRUGPricktestlösung
DRUGPHENOL
DRUGWATER FOR INJECTION
DRUGHAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus
DRUGHAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Farinae
DRUGMOMETASONE
DRUGPRICK TEST Beifuss LETI
DRUG30 HEP/ml Pricktestlösung.
DRUGHAL Allergy Prick Test Aspergillus Fumigatus
DRUGLORATADINE
DRUGHAL Allergy Prick Test Positieve Controle 10 mg/ml
DRUGoplossing voor huidpriktest
DRUGHAL Allergy Prick Test Frühblühende Bäume Mischung I
DRUGHAL Allergy Provo Spray
DRUGProvokationstestlösung
DRUGNasenspray
DRUGHAL Allergy Prick Test Katzenepithelien
DRUGSODIUM CHLORIDE
DRUGHAL Allergy Prick Test Hundeepithelien
DRUGALUMINIUM HYDROXIDE
DRUGHAL Allergy Prick Test Gräserpollen-Mischung
DRUGAZELASTINE

Sponsors

HAL Allergy B.V.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Average daily TCRS during the last 8 weeks of treatment.—

Secondary

MeasureTime frame
Average daily TNSS during the last 8 weeks of treatment., Average daily RMS during the last 8 weeks of treatment., Average daily TCCS during the last 8 weeks of treatment., Change from baseline in NPT (Lebel score) at the end of treatment., Change from baseline in IgE, IgG, IgG4 levels against D. pter and D. far at the end of treatment., RQLQ(S) at the end of treatment., Safety and tolerability during the entire treatment period assessed by treatment-related adverse events, local and systemic reactions., Safety of the treatment on asthma parameters assessed by asthma-related concomitant medication use, asthma related adverse events and lung function tests.—

Countries

Austria, Bulgaria, Germany, Latvia, Lithuania, Poland

Outcome results

None listed

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