jRCT2021220009进行中（未招募）不适用
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
GlaxoSmithKline K.K.0 个研究点目标入组 750 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
- 主要终点
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) over 52 weeks
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
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
- •Current smokers.
- •Participants with allergy/intolerance to the excipients of GSK3511294, a monoclonal antibody, or biologic.
- •Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation.
- •Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study.
- •Other investigational product/clinical study:
- •Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term ""investigational"" applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products.
- •Participants who are currently participating in any other interventional clinical study.
结局指标
主要结局
Number of participants with adverse events (AEs) and serious adverse events (SAEs) over 52 weeks
时间窗: Up to Week 52
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with immunogenicity as measured by the presence of anti-drug antibody (ADA)/Neutralizing antibody (NAb) to GSK3511294 over 52 weeks
时间窗: Up to Week 52
Number of participants with immunogenicity as measured by the presence of anti-drug antibody (ADA)/Neutralizing antibody (NAb) to GSK3511294
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic PhenotypeAsthmaNCT04718103GlaxoSmithKline397
招募中
不适用
A Phase 1 study of GSK5764227 in participants with advanced solid tumorsjRCT2031240381GlaxoSmithKline K.K.15
尚未招募
2 期
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of AgePaediatricsMalariaPACTR201905692900706GlaxoSmithKline Biologicals1,500
尚未招募
不适用
A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostrate CancerjRCT2031250111GlaxoSmithKline K.K.7
已完成
1 期
GSK1349572 First Time in Human StudyHealthy SubjectsNCT00555035GlaxoSmithKline20