A 28-day, Single-armed, Open-label Trial to Evaluate Safety of the House Dust Mite (HDM) Sublingual Allergy Immunotherapy (SLIT) Tablet in Adolescent Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 53
- 主要终点
- Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis.
The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies.
The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.
详细描述
This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Non applicable
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Male or female subjects aged ≥12 to ≤17 years
- •A clinical history of allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM
- •Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening
- •Lung function measured by Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value or according to local requirements while on subject's usual asthma medication
- •The subject must be willing and able to comply with trial protocol and adhere to IMP treatment
排除标准
- •A subject who has previously been included in studies with the HDM SLIT-tablet, or otherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA)
- •Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months prior to visit 1
- •Ongoing treatment with any allergy immunotherapy product at screening
- •Severe chronic oral inflammation
- •A diagnosis or history of eosinophilic oesophagitis
- •Any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration
- •Female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial
- •Sexually active female of childbearing potential without medically accepted contraceptive method
结局指标
主要结局
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
时间窗: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
At least one TEAE
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
时间窗: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
At least one TEAE
Number of Treatment-emergent Adverse Events (TEAEs)
时间窗: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
At least one TEAE
次要结局
- Number of IMP-related Adverse Events (AEs)(From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.)
- Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)(From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.)
- Proportion of Subjects With at Least One IMP-related Adverse Event (AE)(From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.)
- Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)(From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.)
- Number of Solicited Treatment-emergent Adverse Events (TEAEs)(From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.)
- Number of Subjects With at Least One IMP-related Adverse Event (AE)(From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.)
- Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)(From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.)
- Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)(From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.)
- Number of Treatment-emergent Serious Adverse Events (SAEs)(From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.)