A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 163
- 试验地点
- 74
- 主要终点
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.
详细描述
This was a 3-year extension study with a 16-week follow-up period. The study enabled participants from planned multiple Phase III "core" studies to roll over to this extension study once the participants had completed predefined minimal requirements of a "core" study and agreed to consent to participate in this study.
Participants received ligelizumab treatment allocated in the core study, except for maximum responder (MR) participants performing conditional discontinuation of study treatment. Any participant considered a MR, as defined by an oral food challenge (OFC), performed conditional discontinuation of study treatment. This was to assess whether further treatment was still required because of disease modification by ligelizumab and/or a change in the underlying phenotype following the natural history of the disease (outgrowth of allergy) demonstrated by sustained unresponsiveness.
A subset of participants was offered administration of study treatment at home either by the participant him/herself (self-administration) or by parent/caregiver following training at three visits at the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 6 Years 至 57 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent and or/assent (where applicable) obtained from participant/legal representative prior to enrolling in the rollover study and receiving study medication. If a minor participant providing assent reached the age of legal majority (as defined by local law), he/she was to be re-consented at the next study visit.
- •Participants had completed the treatment period in any ligelizumab's Phase III studies in food allergy.
- •Participants who were willing to adhere to the study visits and procedures, including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge).
- •Participants who agreed to continue avoiding exposure to allergens (per core study) and any other foods they were allergic to throughout this study.
- •Participants who were able to safely continue into the study as judged by the investigator.
排除标准
- •Development of a severe or life-threatening episode of an allergic reaction that required intubation and/or intensive care unit (ICU) admission during the core studies.
- •Development of a serious adverse event which was suspected to be related to the study treatment judged by the investigator during the core study.
- •Development of uncontrolled asthma during the core study that compromised the safety of the participants judged by the investigator.
- •Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator.
- •Participants who failed to comply with the protocol requirements and procedures during the core study, and in the Investigator's opinion, should not participate in this extension study.
- •Platelets <75,000/ul at end of treatment of the core study.
研究组 & 干预措施
Ligelizumab 120 mg
Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.
干预措施: Ligelizumab 120 mg (Drug)
Ligelizumab 240 mg
Participants received ligelizumab 240 mg every 4 weeks.
干预措施: Ligelizumab 240 mg (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
时间窗: Up to approximately 81 weeks
TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment.
次要结局
- Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms(Up to approximately 97 weeks)
- Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug(Up to approximately 81 weeks)
- Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF)(Up to approximately 97 weeks)
- Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF)(Up to approximately 97 weeks)
- Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF)(Up to approximately 97 weeks)
- Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Adult Form (FAIM-AF)(Up to approximately 97 weeks)
- Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS)(Up to approximately 97 weeks)