A Multi-centre, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety of GSK3511294 (Depemokimab) in Adult and Adolescent Participants With Severe Asthma With an Eosinophilic Phenotype From Studies 206713 or 213744
概览
- 阶段
- 3 期
- 干预措施
- GSK3511294 (Depemokimab)
- 疾病 / 适应症
- Asthma
- 发起方
- GlaxoSmithKline
- 入组人数
- 641
- 试验地点
- 137
- 主要终点
- Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic phenotype following completion of clinical studies 206713 or 213744.
研究者
入排标准
入选标准
- •Participants who completed the double-blind study intervention treatment during Study 206713 or Study
- •Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
排除标准
- •Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
- •A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localized carcinoma of the skin that was resected for cure will not be excluded).
- •Participants who have other clinically significant medical conditions uncontrolled with Standard of Care (SoC) therapy not associated with Asthma, for example (e.g.), uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study.
- •Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK
- •Participants who meet the following based on results of Week 48 assessment from Study 206713 or Study 213744 or from a later result:
- •Alanine aminotransferase (ALT) greater than (\>)2 times upper limit of normal (ULN).
- •Total bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than \[\<\] 35 percent \[%\]).
- •Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
- •Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
- •Electrocardiogram (ECG) assessment: QTc corrected by Fridericia's formula (QTcF) greater than or equal to (\>=)450 milliseconds (msec) or QTcF \>=480 msec for participants with Bundle Branch Block at Visit
研究组 & 干预措施
Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)
干预措施: GSK3511294 (Depemokimab)
结局指标
主要结局
Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
时间窗: Up to Week 56
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA)
时间窗: Up to Week 52
Serum samples were collected for the determination of anti-GSK3511294 antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive worst case post-Baseline ADA result. Number of participants with worst case post-Baseline positive anti-GSK3511294 antibodies are presented.
Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies
时间窗: Up to Week 52
Blood samples were collected for the determination of positive neutralizing antibodies. Neutralizing antibody (NAb) test was only carried out on samples that were positive in the confirmatory binding antibody assay. A participant was considered positive for NAb if they had at least one positive worst case post-Baseline neutralizing antibody result. Number of participants with worst case post-Baseline positive neutralizing antibodies are presented.
次要结局
- Annualized Rate of Clinically Significant Exacerbations(Up to Week 52)
- Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score(Baseline (Day 1), Weeks 4, 8, 12, 20, 26, 28, 32, 40 and 52)
- Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 26 and 52(Baseline (Day 1), Weeks 26 and 52)
- Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at Weeks 26 and 52(Baseline (Day 1), Weeks 26 and 52)