NCT05621317进行中（未招募）2 期
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- Ratio of maximum tolerated dose (MTD) of peanut protein at the Week 46 double blind placebo-controlled food challenge (DBPCFC) relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo
研究概览
简要总结
The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with peanut allergy.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed immunoglobulin E (IgE) mediated peanut allergy;
- •Peanut specific serum IgE measured by ImmunoCAP® ≥ 0.7 kilounit allergy specific antibody per litre (kUA/L) at screening;
- •Positive skin prick test to peanut with mean wheal diameter ≥5 mm greater than negative control at screening;
- •Positive peanut double blind placebo-controlled food challenge (DBPCFC) with a reactive dose ≤300 mg peanut protein (≤443 mg cumulative reactive dose [CRD]);
- •Able to perform spirometry or peak expiratory flow. Children who are 4 years of age at Screening Stage 1 visit and unable to perform peak expiratory may be enrolled providing they had no clinical features of moderate or severe persistent asthma within 1 year prior to the Screening visit;
- •Forced expiratory volume in 1 second (FEV1) ≥80% predicted in adolescents and children with asthma capable of performing spirometry, or peak expiratory flow ≥80% predicted in participants with asthma unable to perform spirometry (at investigator's discretion).
排除标准
- •History of or current clinically significant medical conditions or laboratory abnormalities which in the opinion of the investigator would jeopardise the safety of the participant or the validity of the study results;
- •Severe or unstable asthma as assessed by the Global Initiative for Asthma (GINA) assessment of asthma control OR current treatment for asthma at GINA ≥Step 4 level;
- •Participants with skin disorders that would hinder skin prick testing and/or its interpretation or study drug administration (eg, severe generalised poorly controllable atopic dermatitis);
- •Any medical condition in which epinephrine (adrenaline) is contraindicated;
- •Prior therapy aimed at desensitising peanut allergy, either in a formal study or in clinical practice;
- •Severe or life-threatening reaction during the screening food challenge, at investigator discretion.
研究组 & 干预措施
PVX108 50 nmol in adolescents
Experimental
Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1)
干预措施: PVX-108 (Biological)
Placebo in adolescents
Placebo Comparator
Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1)
干预措施: Placebo (Biological)
PVX108 5 nmol in children
Experimental
Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2)
干预措施: PVX-108 (Biological)
PVX108 50 nmol in children
Experimental
Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2)
干预措施: PVX-108 (Biological)
Placebo in children
Placebo Comparator
Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2)
干预措施: Placebo (Biological)
结局指标
主要结局
Ratio of maximum tolerated dose (MTD) of peanut protein at the Week 46 double blind placebo-controlled food challenge (DBPCFC) relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo
时间窗: 46 weeks
次要结局
- Percentage of children aged 4 to 11 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 46 DBPCFC compared to placebo(46 weeks)
- Ratio of MTD of peanut protein at the Week 71 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo(71 weeks)
- Percentage of children aged 4 to 11 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 71 DBPCFC compared to placebo(71 weeks)
- Ratio of cumulative reactive dose (CRD) of peanut protein at the Week 46 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo(46 weeks)
- Ratio of CRD of peanut protein at the Week 71 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo(71 weeks)
- Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo(71 weeks)
- Frequency of events of each severity grade during the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo(46 weeks)
- Frequency of events of each severity grade during the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo(71 weeks)
- Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo(46 weeks)
- Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) during 45 weeks treatment and 26 weeks following treatment with PVX108 compared to placebo(Up to 74 weeks)
- Change from baseline in peak expiratory flow(Up to 73 weeks)
- Severity of symptoms upon unintentional exposure to peanut (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007)(Up to 73 weeks)
- Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs(Up to 46 weeks)
- Number of participants with abnormal physical examination data(Up to 74 weeks)
- Incidence of concomitant medication use(Up to 74 weeks)
- Number of participants with abnormal vital signs(Up to 74 weeks)
- Number of participants with abnormal clinical laboratory data(Up to 74 weeks)
研究者
研究点 (14)
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