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

NCT07096440 | Not Yet Recruiting

• 1 other identifier: AL2501NH
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Allergen Immunotherapy; Allergopharma; Novo-Helisen Depot; Allergy; House Dust Mites; One Strength; NHD (D.p./D.f.); NHD; Children; poland; SCIT

Outcome Measures

Primary Outcomes (2)

• Safety of the One Strength dose escalation scheme in daily practice

  * Number, incidence, type, intensity and time of occurrence of (serious) adverse events ((S)AEs) * Number, incidence, type, intensity and time of occurrence of (serious) adverse drug reactions ((S)ADRs) * Frequency and intensity of systemic allergic reactions * Proportion of patients who reach the maintenance dose without/with dose adjustment

  up to study completion, approximately 11 to 20 weeks

• Tolerability of the One Strength dose escalation scheme in daily practice

  Tolerability will be assessed by both the treating physicians and the patients using a 5-point Likert scale (Likert, 1932) with the following categories: "Very bad," "Bad," "Average," "Good," and "Very good".

  up to study completion, approximately 11 to 20 weeks

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This NIS will enroll a total of 105 patients, including 35 children (aged ≥5 to \< 12 years), 35 adolescents (aged ≥12 to \<18 years), and 35 adults (aged ≥ 18 years). Patient recruitment will be conducted at six to eight allergy-specialized study sites across Poland. Participation in this NIS follows the independent and prior decision by the treating physician and the patient to begin therapy with the One Strength dose escalation scheme of NHD (D.p./D.f.). The indication and use of the One Strength up-dosing scheme of NHD (D.p./D.f.) is based exclusively on the individual therapeutic need.

You may qualify if:

• Written informed consent from the patient. For patients under the age of 18, the consent of both parents/legal guardians is also required.
• Patients who are eligible for treatment with the One Strength dose escalation scheme of NHD (D.p./D.f.) according to the specifications in the SmPC. These include children (5 to \<12 years), adolescents (≥12 to \<18 years) and adults (≥18 years) with allergic (IgE-mediated) diseases, such as allergic rhinitis, allergic conjunctivitis, allergic bronchial asthma (see section 4 of the current SmPC)
• The treatment decision must precede the decision to participate in the study and must be independent.

You may not qualify if:

• Any contraindication according to section 4.3 of the current SmPC for NHD (D.p./D.f.) for the One Strength dose escalation scheme.

Sponsors & Collaborators

• Allergopharma GmbH & Co. KG: lead

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Prof. Dr. med. Marek Jutel

  "ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Werner, PhD

CONTACT

+49 40 72765178; susanne.werner@dermapharm.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 31, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share