Patients with house dust mites related allergic rhinitis/rhinoconjunctivitis and well-controlled mild-to-moderate or without asthma MedDRA version: 21.1 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: PT Classification code 10010744 Term: Conjunctivitis allergic System Organ Class: 10015919 - Eye disorders MedDRA version: 21.1 Level: LLT Classification code 10001705 Term:
Conditions
Interventions
Product Name: SULGEN® Spray D. pteronyssinus
Pharmaceutical Form: Sublingual spray, solution
Pharmaceutical form of the placebo: Sublingual spray, solution
Route of administration of the placebo: Sub
Sponsors
ROXALL Medizin GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients who signed and dated informed consent form obtained prior to any study specific examination • Female or male patients between 18 and 65 years of age at the time of signing the informed consent form • Patients with moderate-to-severe allergic rhinitis / rhino-conjunctivitis due to house dust mites (HDM) for at least one year according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline • Patients with well controlled mild-to-moderate or without asthma defined in GINA guideline (Global Initiative for Asthma, 2022) • Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients) • Sensitization to Dermatophagoides pteronyssinus, verified by : - positive skin prick test (wheal diameter = 3 mm and negative control =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous immunotherapy with allergen extract of house dust mites (HDM) according to the homologous group of the Dermatophagoides genus, as defined in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831) within the last 5 years • Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen (with exception of D. farinae), which interfere with the conduct of the study (e. g. with the tNPT), especially if the result in SPT for this allergen is higher than that for D. pteronyssinus • Patients with co-sensitizations to any perennial or seasonal allergen with overlapping during PMP but which are not cross-reactive with D. pteronyssinus and with specific IgE levels = class 2 CAP/PHADIA • Simultaneous participation in other clinical trials • Simultaneous specific immunotherapy with other allergens • Participation in a clinical trial in the last three months before enrolment • Contraindications for SLIT (Pitsios et al., 2015) • Contraindications for SPT • Contraindications for NPT • Serious systemic reactions to allergen-specific immunotherapy in the past • Hypersensitivity to excipients of the IMP • Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD • Severe, or partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2022) • Asthmatic patients with FEV1 = 70 % of predicted normal value at screening • Chronic or severe acute diseases of nose or eyes • Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis) • Therapy with immunoglobulins • Completed or ongoing treatment with anti-IgE-antibody • Diseases of the immune system including autoimmune and immune deficiencies (with exception to well-controlled Hashimoto thyroiditis and type-1 diabetes mellitus) • Severe acute or chronic inflammatory or infectious diseases • Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function • Malignancy within the previous 5 years • Active chronic urticaria • Active severe atopic eczema • Alcohol, drug, or medication abuse within the past year and/or during the study • Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening • Use of non-allowed medication • Severe psychiatric, psychological, or neurological disorders; completed or ongoing long-term treatment with tranquilizer or psychoactive drugs (including tricyclic anti-depressants) • Relationship or dependence with the sponsor and/or investigator • Legal incapacity • Patients who are jurisdictional or governmentally institutionalized • Risk of non-compliance by the patient with the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to establish the most effective and best-tolerated dose of SULGEN® Spray D. pteronyssinus in terms of benefit-risk balance and CSMS (Combined Symptom and Medication Score). ;Secondary Objective: The secondary objective of the study is to support the evaluation of the efficacy of each dose treatment with SULGEN® Spray D. pteronyssinus compared to the placebo.;Primary end point(s): Primary efficacy endpoint The primary (efficacy) endpoint is defined as the absolute differences in mean CSMS (Combined Symptom and Medication Score) during the PMP of each active treatment group compared to the placebo treatment group. The CSMS is the EAACI-recommended end point for pivotal studies, described in detail in a Position Paper. Briefly, CSMS is the sum of the daily symptom score (dSS) plus daily medication score (dMS). ;Timepoint(s) of evaluation of this end point: 15.04.2023 - 10.06.2025 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints : - Absolute and relative differences in mean dSS during PMP. - Absolute and relative differences in mean dMS during PMP. - Global Rhinoconjunctivitis Discomfort with a 10-point Visual Analogue Scale (VAS). - Change in Rhinoconjunctivitis quality of life questionnaire (RQLQ) between active and placebo treatment groups comparing basal and post-treatment scoring. - Well and severe days: A well day is defined as a day without administration of any rescue medication (dMS = 0) and with dSS < 0.5 (range 0-3). A severe day is defined (acc. to Pfaar et al. 2014b) as a day with a single score = 3 in any of the four symptoms. Percentages of well and severe days will be calculated for each subject as the number of well or severe days in the PMP in relation to 56 days comprising the PMP. - Symptom-free days during PMP are defined as the days with absence of symptoms (dSS = 0) and without administration of any rescue medication (dMS = 0), expressed as percentage of days during the PMP. - tNPT titrated Nasal Provocation Test: To assess the efficacy of each dose of SULGEN® Spray D. pteronyssinus compared to placebo. Defined as percentage of patients with an increased dosing step and the change in number of dosing steps needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five study groups. This is based on the change of the response to nasal provocation (tNPT) with incremental concentrations of an allergen extract of D. pteronyssinus from baseline to end of treatment. Secondary safety endpoint : - To analyse the safety and tolerability of each dose of SULGEN® Spray D. pteronyssinus compared to placebo by Treatment-Emergent Adverse Drug Reactions (TEADR) and patients affected with TEADRs in each group. ;Timepoint(s) of evaluation of this end point: 15.04.2023 - 10.06.2025 | — |
Countries
Germany, Kazakhstan, Turkey, Ukraine
Contacts
Public ContactMedical Manager
ROXALL Medizin GmbH
Outcome results
None listed