2024-517515-75-00招募中3 期
Phase II-III study to assess the efficacy and safety of subcutaneous cluster-immunotherapy in patients suffering from birch pollen allergy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- The primary (efficacy) endpoint is defined as the absolute differences in mean CSMS (Combined Symptom and Medication Score) during Peak Birch Pollen Period (PBPP) of each active treatment group compared with placebo treatment group.
研究概览
简要总结
The purpose of this trial is to establish the most effective and best-tolerated dose of CLU-RX-BET in terms of benefit-risk balance and CSMS (Combined Symptom and Medication Score).
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients who signed and dated the 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 birch pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline (Bousquet et al., 2008), with well-controlled mild-to-moderate asthma defined in GINA guidelines (Global Initiative for Asthma, 2024), or without asthma
- •Forced expiratory volume (FEV1) in one second > 80 % of predicted normal value (only for asthmatic patients)
- •Sensitization to Betula verrucosa 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 Betula verrucosa ≥ 0.7 kU/L (CAP EAST class ≥ 2) and a Retrospective Rhinitis Total Symptom Score (RRTSS) ≥ 2 (0-3 scale) based on the most severe days during one of the two BPS preceding enrolment and positive response to nasal provocation with Betula verrucosa pollen allergen extract (at least at the third concentration step)
- •Assumed compliance and ability of the patient to understand the patient´s electronic diary and to follow the instructions of the study staff
- •Compliance and ability of the patient to complete an electronic diary for self-evaluation of the symptoms and rescue medication
- •Safety laboratory results within the normal range or considered to be not clinically significant in any other case
排除标准
- •Previous immunotherapy with birch pollen allergen extracts according to the homologous group of tree pollen of the "Birch group" / “Fagales group”, 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
- •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, 2024)
- •Asthmatic patients with FEV1 ≤ 80 % 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 (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)
- •Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen (with exception of alder, hazel and hornbeam), 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 Betula verrucosa
- •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 women with child-bearing potential or a positive pregnancy test at screening
- •Systemic and local (eye drops) treatment with beta-blockers
- •Use of non-allowed medication
- •Contraindication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma)
- •Patients with co-sensitizations to any perennial or seasonal allergen overlapping during PBPP or BPS but which are not cross-reactive with Betula verrucosa and, measured at the same time, with specific IgE levels ≥ class 2 CAP/PHADIA (unless the relevance can be excluded by component resolved diagnosis)
- •Severe psychiatric, psychological, or neurological disorders; completed or ongoing longterm 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
- •Simultaneous participation in other clinical trials
- •Simultaneous specific immunotherapy with other allergens
- •Participation, meaning randomization, in a clinical trial in the last three months before enrolment
- •Contraindications for SCIT (Pfaar et al., 2022; Pitsios et al., 2015)
- •Contraindications for SPT
- •Contraindications for NPT
结局指标
主要结局
The primary (efficacy) endpoint is defined as the absolute differences in mean CSMS (Combined Symptom and Medication Score) during Peak Birch Pollen Period (PBPP) of each active treatment group compared with placebo treatment group.
The primary (efficacy) endpoint is defined as the absolute differences in mean CSMS (Combined Symptom and Medication Score) during Peak Birch Pollen Period (PBPP) of each active treatment group compared with placebo treatment group.
次要结局
- Absolute and relative differences in mean CSMS during the Birch Pollen Season (BPS) between active and placebo treatment groups.
- Absolute and relative differences in mean dSS during PBPP and BPS.
- Absolute and relative differences in the 6 mean individual symptom scores (4 nasal and 2 ocular) during PBPP and BPS.
- Absolute and relative differences in mean dMS during PBPP and BPS.
- Global Rhinoconjunctivitis Discomfort with a 10.0-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 PBPP and BPS in relation to the number of days comprising both periods.
- Symptom-free days during PBPP and PBP 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 PBPP and BPS.
- tNPT titrated Nasal Provocation Test: To assess the efficacy of each dose of CLURX- BET 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)
- To analyse the safety and tolerability of each dose of CLU-RX-BET compared to placebo by Treatment-Emergent Adverse Drug Reactions (TEADR) and patients affected with TEADRs in each group.
研究者
Leire Begona
Scientific
ROXALL Medizin GmbH
研究点 (3)
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