問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol Number212895
NCT Number(ClinicalTrials.gov Identfier)NCT05243680

2022-09-30 - 2025-05-31

Phase III

Recruiting9

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Ping-Hung Kuo Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming -Cheng Chan Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林慶雄 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shu-Min Lin Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭世隆 Division of Thoracic Medicine
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曹世明 Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Xin-Min Liao Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Asthma

Objectives

Primary (Security) • To describe the long-term safety profile of GSK3511294 100 mg (SC) every 26 weeks in participants with severe asthma with an eosinophilic phenotype during a 12-month open-label extension period on existing asthma therapy Secondary (Efficacy) • To evaluate the effects of long-term administration of GSK3511294 100 mg (SC) every 26 weeks on various clinical markers of asthma control and other efficacy measures in a 12-month open-label extension period in addition to existing asthma therapy

Test Drug

GSK3511294

Active Ingredient

GSK3511294

Dosage Form

PFS

Dosage

100 mg/mL

Endpoints

Primary (Security)
• Incidence of adverse events (AEs)/serious adverse events (SAEs) during 52 weeks
• The incidence of immunogenicity during 52 weeks, as measured by the presence of GSK3511294 anti-drug antibodies (ADA)/neutralizing antibodies (Nab)
Secondary (Efficacy)
• Annualized incidence of clinically significant acute exacerbations during the 52-week period
• Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) scores at discrete time points over 52 weeks
• Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52
• Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Weeks 26 and 52

Inclution Criteria

Inclusion criteria:

Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744.
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.

Exclusion Criteria

Exclusion criteria:

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 GSK3511294.
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 1.
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.

The Estimated Number of Participants

  • Taiwan

    27 participants

  • Global

    540 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB