Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites

The goal of this non-interventional study is to investigate the safety and tolerability of a new simplified up-dosing schedule for Novo-Helisen Depot. Novo-Helisen Depot is an approved allergen immunotherapy used to treat allergies to house dust mites. For allergen immunotherapy, it is important that the allergen dose is gradually increased, a process known as up-dosing to induce immune tolerance to the allergen. The recently approved One Strength up-dosing scheme for Novo-Helisen Depot allows up-dosing with 6 injections instead of the previously required 14 injections. The main questions the study aims to answer are: How is the tolerability and the safety of One Strength up-dosing scheme in daily practice? This study includes approximately 105 patients (children (≥5 years), adolescents, and adults), receiving this treatment as part of their usual care. Study data on safety and tolerability wil be collected for each patient during the first 8 injection visits. The study will be conducted at 6-8 study sites in Poland.

NCT Number	NCT07096440
Lead Sponsor	Allergopharma GmbH & Co. KG
Conditions	Allergic Rhinitis Due to House Dust Mite, Allergic Conjunctivitis Due to Dermatophagoides Farinae, Allergic Conjunctivitis Due to Dermatophagoides Pteronyssinus, Allergic Asthma Due to Dermatophagoides Farinae, Allergic Asthma Due to Dermatophagoides Pteronyssinus
Enrollment	105 participants
Start Date	2025-07-30
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-31