Patients with grass pollen-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
Conditions
Interventions
Product Name: CLUSTOID Phleum pratense
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Subcutaneous u
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/rhinoconjunctivitis due to grass pollen for at least two years, according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline, either - with well-controlled mild-to-moderate asthma defined in GINA guideline (Global Initiative for Asthma, 2022) - or without Asthma • Forced expiratory volume (FEV1) in one second > 80 % of predicted normal value (only for asthmatic patients) • Sensitization to Phleum pratense pollen, 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 grass pollen allergen extracts according to the homologous group of grass pollen of the "Poaceae group", 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, 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 Phleum pratense • Patients with co-sensitizations to any pollen or mould with overlapping seasons but which are not cross-reactive with Phleum pratense and with specific IgE levels = class 2 CAP/PHADIA (unless the relevance can be excluded by component resolved diagnosis) • Simultaneous participation in other clinical trials • Simultaneous specific immunotherapy with other allergens • Participation in a trial in the last three months before enrolment • Contraindications for SCIT (Pfaar et al., 2014a; 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 = 80 % of predicted normal value at screening • Chronic or severe acute diseases of the 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 (like Omalizumab) and/or checkpoint-inhibitor • 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 • Systemic and local (eye drops) treatment with beta-blockers • Use of non-allowed medication (see section 5.3.1) • Contraindication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma) • 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 purpose and main objective of this trial is to establish the most effective and best-tolerated dose with CLUSTOID® Phleum pratense 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 CLUSTOID® Phleum pratense compared to 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 Peak Grass Pollen Period (PGPP) of each active treatment group compared to placebo treatment group. ;Timepoint(s) of evaluation of this end point: 15.10.2023 to 30.11.2025 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: - Absolute and relative differences in mean CSMS during Grass Pollen Season (GPS) between active and placebo treatment groups. - Absolute and relative differences in mean dSS during PGPP and GPS. - Absolute and relative differences in mean dMS during PGPP and GPS. - 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 < 0.34 (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 six symptoms. Percentages of well and severe days will be calculated for each subject as the number of well or severe days in the PGPP and GPS in relation to the number of days comprising both periods. - Symptom-free days during pollen season 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 PGPP and GPS. - tNPT titrated Nasal Provocation Test: To assess the efficacy of each dose of CLUSTOID® Phleum pratense 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 four study groups. This is based on the change of the response to nasal provocation (tNPT) with incremental concentrations of an allergen extract of Phleum pratense from baseline to end of treatment. Secondary safety endpoint: - To analyse the safety and tolerability of each dose of CLUSTOID® Phleum pratense compared to placebo by Treatment-Emergent Adverse Drug | — |
Countries
Germany, Kazakhstan, Turkey, Ukraine
Contacts
Public ContactMedical Manager
ROXALL Medizin GmbH
Outcome results
None listed