臨床研究等提出・公開システム

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

A Study of GSK3511294 (Depemokimab) in participants who were previously enrolled In 206713 or 213744; Open-Label Extension

Kamimoto Masato

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo

212895_JAPAN_jRCT@iqvia.com

Kuwahara Chiaki

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo

+81-120-229-053

212895_JAPAN_jRCT@iqvia.com

Not Recruiting

July. 11, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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.

- 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:
1. Alanine aminotransferase (ALT) greater than (>)2 times upper limit of normal (ULN).
2. 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 [%]).
3. 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:
1. 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.
2. Participants who are currently participating in any other interventional clinical study.

Both

asthma

Biological: GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.

- Number of participants with adverse events (AEs) and serious adverse events (SAEs) over 52 weeks [ Time Frame: Up to Week 52 ]
- Number of participants with immunogenicity as measured by the presence of anti-drug antibody (ADA)/Neutralizing antibody (NAb) to GSK3511294 over 52 weeks [ Time Frame: Up to Week 52 ]

+81-22-346-0325

May. 23, 2022

Yes

[Plan Description] IPD for this study will be made available via the Clinical Study Data Request site. [URL] http://clinicalstudydatarequest.com

none