DERMATOPHAGOIDES PTERONYSSINUS EXTRACT for Allergic rhinitis due to house dust mite | Allergic rhinoconjunctivitis

Inclusion criteria

• {"criterion_text":"- Patients who signed and dated the informed consent form obtained prior to any study specific examination\n- Female or male patients between 18 and 65 years of age at the time of signing the informed consent form\n- Patients with moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to house dust mites (HDM) for at least one year according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline (Bousquet et al., 2008), either with well-controlled mild-to-moderate asthma defined in GINA guideline (Global Initiative for Asthma, 2025) or without asthma\n- Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients)\n- Sensitization to Dermatophagoides pteronyssinus, verified by: positive skin prick test (wheal diameter ≥ 3 mm and negative control < 2 mm and positive (histamine) control ≥ 3 mm) and serum allergen-specific IgE to D. pteronyssinus ≥ 0.7 kU/L (CAP EAST class ≥ 2) and a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) ≥ 2 (0-3 scale) based on the most severe days during winter preceding enrolment and positive response to nasal provocation with D. pteronyssinus allergen extract (at least at the third concentration step)\n- Assumed compliance and ability of the patient to understand the patient’s electronic diary and to follow the instructions of the study staff\n- Compliance and ability of the patient to complete an electronic diary for self-evaluation of the symptoms and rescue medication\n- Safety laboratory results within the normal range or considered to be not clinically significant in any other case"}

Exclusion criteria

• {"criterion_text":"- Previous immunotherapy with allergen extract of house dust mites (HDM) according to the homologous group of Dermatophagoides genus, as defined in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831/2008), within the last 5 years\n- Patients with co-sensitizations or co-allergies to any perennial, such as moulds, or seasonal allergen overlapping with the PEEP but which are not cross-reactive with D. pteronyssinus and, measured at the same time, with specific IgE levels ≥ class 2 CAP/PHADIA (unless the relevance can be excluded by component resolved diagnosis)\n- 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 or CSMS recording), especially if the result in SPT for this allergen is higher than that for D. pteronyssinus\n- Simultaneous participation in other clinical trials or finished randomized participation within the last year before enrolment in this clinical trial, although the patient could be screened but not randomized in another clinical trial at least three months before enrolment in this clinical trial\n- Simultaneous specific immunotherapy with other allergens\n- Contraindications for SLIT (Pitsios et al., 2015)\n- Contraindications for SPT\n- Contraindications for NPT\n- Serious systemic reactions to allergen-specific immunotherapy in the past\n- Hypersensitivity to excipients of the IMP\n- Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD\n- Severe, or partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2025)\n- Asthmatic patients with FEV1 ≤ 70 % of predicted normal value at screening\n- Chronic or severe acute diseases of nose or eyes\n- Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis)\n- Therapy with immunoglobulins\n- Completed or ongoing treatment with an anti-IgE-antibody (like omalizumab) and/or checkpoint-inhibitor\n- Diseases of the immune system including autoimmune and immune deficiencies (with exception to well-controlled Hashimoto thyroiditis and type-1 diabetes mellitus)\n- Severe acute or chronic inflammatory or infectious diseases\n- Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function\n- Malignancy within the previous 5 years\n- Active chronic urticaria\n- Active severe atopic eczema\n- Alcohol, drug, or medication abuse within the past year and/or during the study\n- Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening\n- Use of non-allowed medication\n- Severe psychiatric, psychological, or neurological disorders; completed or ongoing long-term treatment with tranquilizer or psychoactive drugs (including tricyclic anti-depressants)\n- Relationship or dependence with the sponsor and/or investigator\n- Legal incapacity\n- Patients who are jurisdictional or governmentally institutionalized\n- Risk of non-compliance by the patient with the study procedures"}

Primary endpoints

• {"endpoint_text":"- The primary (efficacy) endpoint is defined as the absolute differences in mean CSMS (Combined Symptom and Medication Score) during PEEP of each active treatment group compared with placebo treatment group.","definition_or_measurement_approach":"Difference in mean CSMS (Combined Symptom and Medication Score) during the PEEP comparing each active treatment group with placebo; measured as absolute differences in mean CSMS during the Peak Exposure Evaluation Period (PEEP)."}

Secondary endpoints

• {"endpoint_text":"- Absolute and relative differences in mean dSS during PEEP\n- Absolute and relative differences in mean dMS during PEEP.\n- Absolute and relative differences in the 4 mean nasal individual symptom scores during PEEP.\n- Change in Global Rhinoconjunctivitis Discomfort with a 10.0-point Visual Analogue Scale (VAS) between active and placebo treatment groups comparing pre- (baseline) and post-treatment scaling.\n- Change in Rhinoconjunctivitis quality of life questionnaire (RQLQ) between active and placebo treatment groups comparing pre- (baseline) and post-treatment scoring\n- 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., 2014) 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 PEEP in relation to 56 days comprising the PEEP.\n- Symptom-free days 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 PEEP.\n- titrated Nasal Provocation Test to assess the efficacy of each dose of SLI-RX-DPT compared to placebo. Defined as % of patients with an increased dosing step and the change in number of dosing steps needed to provoke a positive response in the tNPT post-treatment compared with pre-treatment in each of the 4 treatment groups. This is based on the change of the response to nasal provocation with incremental concentrations of an allergen extract of D. pteronyssinus from baseline to post-treatment.\n- To analyse the safety and tolerability of each dose of SLI-RX-DPT compared to placebo by Treatment-Emergent Adverse Drug Reactions (TEADR) and patients affected with TEADRs in each group","definition_or_measurement_approach":"Secondary endpoints measured during PEEP include mean daily Symptom Score (dSS) and daily Medication Score (dMS) differences (absolute and relative), four individual nasal symptom scores, change in VAS global discomfort (10-point VAS) baseline vs post-treatment, change in RQLQ baseline vs post-treatment, percent well and severe days over the 56-day PEEP (well day: dMS=0 and dSS<0.5; severe day: any single symptom score=3), percent symptom-free days (dSS=0 and dMS=0), tNPT assessed as percent of patients with increased dosing step and change in number of dosing steps from baseline to post-treatment, and safety assessed by TEADRs and number of patients affected."}

Germany

Earliest CTIS Part Ii Submission Date

08-12-2025

Latest Decision Or Authorization Date

13-01-2026

Processing Time Days

36

Number Of Sites

3

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

08-12-2025

Latest Decision Or Authorization Date

19-01-2026

Processing Time Days

42

Number Of Sites

2

Number Of Participants

10

Primary sponsor

Full Name

ROXALL Medizin GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"ICRC-Weyer GmbH","duties_or_roles":"10|6","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MVZ Medizinisches Labor Nord MLN GmbH","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}