NCT04878354已完成3 期
Efficacy and Safety of the SQ Tree Sublingual Immunotherapy Tablet in Children and Adolescents With Moderate to Severe Allergic Rhinitis and/or Conjunctivitis Induced by Pollen From Birch and Trees Belonging to the Birch Homologous Group
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 952
- 试验地点
- 79
- 主要终点
- Average Total Combined Score (TCS) During the Birch Pollen Season (BPS)
研究概览
简要总结
This is a clinical study in children and adolescents (5-17 years) with allergy to pollen from birch (or related trees). It compares the tree SLIT-tablet with placebo in relieving rhinoconjunctivitis symptoms during the birch/tree pollen season based on the average allergic rhinoconjunctivitis daily total combined score.
The study will also collect health-related quality of life information in the groups treated with the tree SLIT-tablet or with placebo during the pollen season.
The trial medication used is already approved to treat allergic rhinitis caused by birch/tree pollen in adults in several countries?.
详细描述
This is a phase III, parallel-group, double-blind, placebo-controlled study to evaluate efficacy and safety of the tree SLIT-tablet in children and adolescents (5-17 years) who have rhinoconjunctivitis (with or without asthma) induced by pollen from birch trees or by trees belonging to the birch homologous group. Approximately 1000 children and adolescents will be enrolled in the trial and will receive either the tree SLIT-tablet or placebo.
The trial consists of 3 periods: a screening period, a treatment period, which includes pre-seasonal and co seasonal treatment, and a follow-up period. The duration is up to 13 months for each participant.
The trial is conducted in several European countries and in Canada.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race/ethnicity aged ≥4 to <18 years on the day informed consent is obtained from the parent/caregiver; the subject must be ≥5 to <18 years old at the randomisation visit
- •A documented , physician diagnosed, clinically relevant history of moderate to severe AR/C induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous tree pollen season for ages 4 through 6 years at screening or at least 2 previous tree pollen seasons for ages 7 through 17 years at screening
- •Positive skin prick test (SPT) to Betula verrucosa at screening
- •Positive specific IgE to Bet v at screening
- •Presence of 1 or more of the following Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to AR/C during the previous BPS:
- •Sleep disturbance
- •Impairment of daily activities, leisure and/or sport
- •Impairment of school or work
- •Troublesome symptoms
排除标准
- •A clinically relevant history of symptomatic seasonal AR/C caused by an allergen source, other than tree pollen from the birch homologous group, with a season overlapping the TPS
- •A clinically relevant history of symptomatic perennial AR/C caused by an allergen source such as animal hair and dander to which the subject is exposed during the TPS
- •Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation
- •Reduced lung function at randomisation defined as forced expiratory volume in 1 second (FEV1) <70% of predicted value. For subjects with asthma, this is assessed on subject's usual asthma medication following at least a 6-hour wash-out of SABA. This criterion does not need to be fulfilled if the subject is <7 years old, cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma
- •Ongoing treatment with any allergy immunotherapy product
- •Severe chronic oral inflammation
- •A diagnosis of eosinophilic oesophagitis
- •A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern
- •Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
研究组 & 干预措施
Placebo
Placebo Comparator
Gelatine (fish source), mannitol and sodium hydroxide
干预措施: Placebo SLIT-tablet (Drug)
Intervention/treatment
Experimental
Sublingual allergy immunotherapy tablet, for daily administration SQ tree SLIT-tablet
干预措施: Tree SLIT-tablet (Drug)
结局指标
主要结局
Average Total Combined Score (TCS) During the Birch Pollen Season (BPS)
时间窗: During the BPS (mean duration of approximately 3-4 weeks)
The primary endpoint of the trial was the average allergic rhinitis and/or conjunctivitis TCS during the BPS. The average TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
次要结局
- Average Total Combined Score (TCS) During the Tree Pollen Season (TPS)(During the TPS (mean duration of approximately 11 weeks))
- Average Daily Symptoms Score (DSS) During the Birch Pollen Season (BPS)(During the BPS (mean duration of approximately 3-4 weeks))
- Average Daily Symptoms Score (DSS) During the Tree Pollen Season (TPS)(During the TPS (mean duration of approximately 11 weeks).)
- Average Daily Medication Score (DMS) During the Birch Pollen Season (BPS)(During the BPS (mean duration of approximately 3-4 weeks))
- Average Daily Medication Score (DMS) During the Tree Pollen Season (TPS)(During the TPS (mean duration of approximately 11 weeks))
- Average Total Combined Score (TCS) During the Alder Hazel Pollen Season (AHPS)(During the AHPS (mean duration of approximately 6-7 weeks))
- Average Daily Symptoms Score (DSS) During the Alder Hazel Pollen Season (AHPS)(During the AHPS (mean duration of approximately 6-7 weeks))
- Average Daily Medication Score (DMS) During the Alder Hazel Pollen Season (AHPS)(During the AHPS (mean duration of approximately 6-7 weeks))
- Average Total Combined Score (TCS) During the Oak Pollen Season (OPS)(During the OPS (mean duration of approximately 3 weeks))
- Average Daily Symptoms Score (DSS) During the Oak Pollen Season (OPS)(During the OPS (mean duration of approximately 3 weeks))
- Average Daily Medication Score (DMS) During the Oak Pollen Season (OPS)(During the OPS (mean duration of approximately 3 weeks))
- Number of Severe Days During the Birch Pollen Season (BPS)(During the BPS (mean duration of approximately 3-4 weeks))
- Number of Severe Days During the Tree Pollen Season (TPS)(During the TPS (mean duration of approximately 11 weeks))
- Number of Well Days During the Birch Pollen Season (BPS)(During the BPS (mean duration of approximately 3-4 weeks))
- Number of Well Days During the Tree Pollen Season (TPS)(During the TPS (mean duration of approximately 11 weeks))
- Number of Symptom-free Days During the Birch Pollen Season (BPS)(During the BPS (mean duration of approximately 3-4 weeks))
- Number of Symptom-free Days During the Tree Pollen Season (TPS)(During the TPS (mean duration of approximately 11 weeks))
- Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Birch Pollen Season (BPS)(During the BPS (mean duration of approximately 3-4 weeks))
- Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Tree Pollen Season (TPS)(During the TPS (mean duration of approximately 11 weeks))
- Average Total Combined Score (TCS) (EAACI Scoring) During Birch Pollen Season (BPS)(During the BPS (mean duration of approximately 3-4 weeks))
- Average Total Combined Score (TCS) (EAACI Scoring) During Tree Pollen Season (TPS)(During the TPS (mean duration of approximately 11 weeks).)
- Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Birch Pollen Season (BPS) (12-17 Years Only)(During the BPS (mean duration of approximately 3-4 weeks))
- Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Tree Pollen Season (TPS) (12-17 Years Only)(During the TPS (mean duration of approximately 11 weeks))
- Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score During the Birch Pollen Season (BPS) (5-11 Years Only)(During the BPS (mean duration of approximately 3-4 weeks))
- Treatment Satisfaction (TSQM-9)(After ending treatment (after approximately 52 weeks of treatment))
- Patient-rated Global Evaluation of Treatment Efficacy(End of treatment (after approximately 52 weeks of treatment))
- Change From Baseline in Birch Specific IgE(From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average))
- Change From Baseline in Birch Specific IgG4(From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average))
- Change From Baseline in Birch Specific IgE-Blocking Factor (IgE-BF)(From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average))
- Change From Baseline in Alder, Hazel and Oak Specific IgE(From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average))
- Change From Baseline in Alder, Hazel and Oak Specific IgG4(From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average))
- Change From Baseline in Alder and Hazel Specific IgE- Blocking Factor (IgE-BF)(From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks treatment, on average))
研究者
研究点 (79)
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