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

NCT07096440 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2025-07-31

No results posted yet for this study

Summary

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.

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

Sponsors & Collaborators

  • Allergopharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. med. Marek Jutel · "ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2026-06-30
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07096440 on ClinicalTrials.gov