ALLERGEN EXTRACT FROM PHLEUM PRATENSE POLLEN, GLUTARALDEHYDE-MODIFIED for Allergic rhinitis due to grass pollen | Allergic rhinoconjunctivitis

Inclusion criteria

• {"criterion_text":"- Patients who signed and dated 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 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 the GINA guideline (Global Initiative for Asthma, 2024) or without asthma\n- Forced expiratory volume (FEV1) in one second > 80 % of predicted normal value (only for asthmatic patients)\n- Sensitization to Phleum pratense pollen, 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 Phleum pratense ≥ 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 one of the two GPS preceding enrolment and a positive response to nasal provocation with Phleum pratense pollen 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 are within the normal range or considered to be not clinically significant in any other case"}

Exclusion criteria

• {"criterion_text":"- 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\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 the GINA guideline (Global Initiative for Asthma, 2024)\n- Asthmatic patients with FEV1 ≤ 80 % 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 anti-IgE-antibody (like omalizumab) and/or checkpoint-inhibitor\n- Diseases of the immune system including autoimmune and immune deficiencies (with exception of well-controlled Hashimoto thyroiditis and type-1 diabetes mellitus)\n- Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen (with the exception of cross-reacting grasses/grains), which interfere with the conduct of the study (e. g. with the tNPT or the CSMS recording), especially if the result in SPT for this allergen is higher than that for Phleum pratense\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 women with childbearing potential or a positive pregnancy test at screening\n- Systemic and local (eye drops) treatment with beta-blockers\n- Use of non-allowed medication\n- Contraindication for adrenaline (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma)\n- Patients with co-sensitizations to any pollen or mould overlapping during PGPP and GPS but which are not cross-reactive with Phleum pratense 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- Severe psychiatric, psychological, or neurological disorders; completed or ongoing long-term treatment with tranquilizers 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\n- Simultaneous participation in other clinical trials\n- Simultaneous specific immunotherapy with other allergens\n- Participation, meaning randomization, in a trial in the last three months before enrolment\n- Contraindications for SCIT (Pfaar et al., 2022; Pitsios et al., 2015)\n- Contraindications for SPT\n- Contraindications for NPT"}

Primary endpoints

• {"endpoint_text":"- 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 with placebo treatment group.","definition_or_measurement_approach":"Mean Combined Symptom and Medication Score (CSMS) during the Peak Grass Pollen Period (PGPP); primary analysis compares absolute differences in mean CSMS between each active dose group and placebo."}

Secondary endpoints

• {"endpoint_text":"- Absolute and relative differences in mean CSMS during the Grass Pollen Season (GPS) between active and placebo treatment groups.","definition_or_measurement_approach":"Comparison of absolute and relative differences in mean CSMS between active and placebo groups during the full Grass Pollen Season (GPS)."}
• {"endpoint_text":"- Absolute and relative differences in mean dSS during PGPP and GPS.","definition_or_measurement_approach":"Comparison of absolute and relative differences in mean daily Symptom Score (dSS) during Peak Grass Pollen Period (PGPP) and Grass Pollen Season (GPS)."}
• {"endpoint_text":"- Absolute and relative differences in the 6 mean individual symptom scores (4 nasal and 2 ocular) during PGPP and GPS.","definition_or_measurement_approach":"Comparison of absolute and relative differences in mean scores for each of six individual symptoms (four nasal, two ocular) during PGPP and GPS."}
• {"endpoint_text":"- Absolute and relative differences in mean dMS during PGPP and GPS.","definition_or_measurement_approach":"Comparison of absolute and relative differences in mean daily Medication Score (dMS) during PGPP and GPS."}
• {"endpoint_text":"- Change in Global Rhinoconjunctivitis Discomfort with a 10.0-point Visuaobl Analogue Scale (VAS) between active and placebo treatment groups comparing basal and post-treatment scaling.","definition_or_measurement_approach":"Change from baseline to post-treatment in Global Rhinoconjunctivitis Discomfort measured by a 10-point Visual Analogue Scale (VAS), compared between active and placebo groups."}
• {"endpoint_text":"- Change in Rhinoconjunctivitis quality of life questionnaire (RQLQ) between active and placebo treatment groups comparing basal and post-treatment scoring","definition_or_measurement_approach":"Change from baseline to post-treatment in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores between active and placebo groups."}
• {"endpoint_text":"- 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 period","definition_or_measurement_approach":"Percentages of well days (dMS = 0 and dSS < 0.34) and severe days (any single symptom score = 3) during PGPP and GPS calculated per subject."}
• {"endpoint_text":"- Symptom-free days during PGPP and PGP 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","definition_or_measurement_approach":"Percentage of days during PGPP and GPS with dSS = 0 and dMS = 0 (symptom-free days)."}
• {"endpoint_text":"- titrated Nasal Provocation Test: To assess the efficacy of each dose of CLU-RX-PHL compared to placebo. Defined as % of patients with an increased dosing step and change in number of dosing steps needed to provoke a positive response in tNPT post-treatment compared with pre-treatment (i. e. any improvement) in each of the 4 treatment groups.This is based on the change of the response to nasal provocation (tNPT) from baseline to end of treatment.","definition_or_measurement_approach":"tNPT: percentage of patients with improvement (increase in dosing step and change in number of dosing steps required to provoke positive response) post-treatment vs pre-treatment, compared across dose groups and placebo."}

Germany

Earliest CTIS Part Ii Submission Date

04-07-2025

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

45

Number Of Sites

3

Number Of Participants

30

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":"[{\"id\":733010,\"code\":\"6\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MVZ Medizinisches Labor Nord MLN GmbH","duties_or_roles":"[{\"id\":733009,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}