Dataset from A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
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下载链接:
https://doi.org/10.25934/00007280
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资源简介:
Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory
airways disease. This study is designed to assess the dose response, efficacy, safety, and
pharmacokinetics of nemiralisib across a range of doses [up to 750 micrograms (µg)] compared
with placebo. The study consists of a Screening Period, a 12-Week Treatment Period and a
12-Week Post-Treatment Follow-Up Period. Approximately 1,250 subjects with an acute moderate
or severe exacerbation of COPD requiring standard of care (SoC) therapy will be randomized in
this double-blind study. Subjects will be randomized to receive different doses of
nemiralisib or placebo via ELLIPTA® inhaler. The total duration of study participation is
approximately 6 months (170 days). ELLIPTA is the registered trademark of GlaxoSmithKline
(GSK) group of companies.
创建时间:
2024-11-26



