Allergic Rhinitis Due to House Dust MiteNOVUS-UPNCT07096440
Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites
An observational study of Allergic Rhinitis Due to House Dust Mite and Allergic Conjunctivitis Due to Dermatophagoides Farinae, run by Allergopharma GmbH & Co. KG.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergic Rhinitis Due to House Dust Mite, Allergic Conjunctivitis Due to Dermatophagoides Farinae, Allergic Conjunctivitis Due to Dermatophagoides Pteronyssinus
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Any contraindication according to section 4.3 of the current SmPC for NHD (D.p./D.f.) for the One Strength dose escalation scheme.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: NOVo-Helisen Depot HoUSe Dust Mites - A Prospective, Multicenter, Noninterventional Clinical Study on the Tolerability and Safety of Short One Strength UP-dosing in Children, Adolescents, and Adults in Daily Practice
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.
Read more
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.
Read the detailed description
The Standard dose escalation scheme with the unmodified (native) SCIT house dust mite preparation Novo-Helisen Depot consists of 14 injections.
The newly approved One Strength dose escalation scheme, recently approved for children (≥5 years), adolescents (12-17 years) and adults (≥18 years), offers a simplified dose escalation scheme with only 6 injections. To date, the safety and tolerability of this One Strength escalation scheme has been demonstrated in 2 clinical trials involving 243 patients (aged 5-65 years). The objective of the present non-interventional study is to compare the safety and tolerability of the One Strength dose escalation scheme (6 injections) in different age groups (children, adolescents, adults) and to supplement available clinical trial data on safety and tolerability with clinical study data in daily practice.
Data collection during the first 8 visits of treatment with NHD (D.p./D.f.) using the One Strength dose escalation scheme:
Visit 1: Informed consent, In-/Exclusion-criteria, demographics, medical history, first injection (dose escalation)
Visits 2-6: 2nd to 6th injection (dose escalation)
Visits 7-8: 7th and 8th injection (maintenance doses)
In line with the SmPC recommendations, all patients must be monitored for at least 30 minutes after each injection and then be examined by the physician. Individually, this observation time may be prolonged.
- 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
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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".
Measured: up to study completion, approximately 11 to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to House Dust MiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Marek Jutel, Principal investigator, "ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096440
- Sponsor's protocol ID
- AL2501NH
- Acronym
- NOVUS-UP
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOVo-Helisen Depot HoUSe Dust Mites - A Prospective, Multicenter, Noninterventional Clinical Study on the Tolerability and Safety of Short One Strength UP-dosing in Children, Adolescents, and Adults in Daily Practice
- ClinicalTrials.gov ID
- NCT07096440
- Acronym / sponsor ID
- NOVUS-UP / AL2501NH
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Standard dose escalation scheme with the unmodified (native) SCIT house dust mite preparation Novo-Helisen Depot consists of 14 injections.
The newly approved One Strength dose escalation scheme, recently approved for children (≥5 years), adolescents (12-17 years) and adults (≥18 years), offers a simplified dose escalation scheme with only 6 injections. To date, the safety and tolerability of this One Strength escalation scheme has been demonstrated in 2 clinical trials involving 243 patients (aged 5-65 years). The objective of the present non-interventional study is to compare the safety and tolerability of the One Strength dose escalation scheme (6 injections) in different age groups (children, adolescents, adults) and to supplement available clinical trial data on safety and tolerability with clinical study data in daily practice.
Data collection during the first 8 visits of treatment with NHD (D.p./D.f.) using the One Strength dose escalation scheme:
Visit 1: Informed consent, In-/Exclusion-criteria, demographics, medical history, first injection (dose escalation)
Visits 2-6: 2nd to 6th injection (dose escalation)
Visits 7-8: 7th and 8th injection (maintenance doses)
In line with the SmPC recommendations, all patients must be monitored for at least 30 minutes after each injection and then be examined by the physician. Individually, this observation time may be prolonged.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Any contraindication according to section 4.3 of the current SmPC for NHD (D.p./D.f.) for the One Strength dose escalation scheme.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of the One Strength dose escalation scheme in daily practice
Time frame: up to study completion, approximately 11 to 20 weeks
* 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
Tolerability of the One Strength dose escalation scheme in daily practice
Time frame: up to study completion, approximately 11 to 20 weeks
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".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. med. Marek Jutel principal investigator
"ALL-MED" Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis Due to House Dust Mite and Allergic Conjunctivitis Due to Dermatophagoides Farinae, run by Allergopharma GmbH & Co. KG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Werner, PhD (+49 40 72765178, susanne.werner@dermapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the One Strength dose escalation scheme in daily practice (time frame: up to study completion, approximately 11 to 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.