Dataset from A Multicenter, Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled Study to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis
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下载链接:
https://doi.org/10.25934/00007130
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资源简介:
This study is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase
inhibitor, in subjects with moderate to severe RA who are currently being treated with
disease modifying anti-rheumatic drugs (DMARDs). The primary objective of the study is to
investigate the safety and tolerability of repeat oral doses of GSK2982772 in subjects with
moderate to severe RA. In addition to the PK, a number of experimental and clinical endpoints
will be employed to obtain information on the PD, and preliminary efficacy in subjects with
active RA. Although no formal hypothesis will be tested, these endpoints will enable a
broader understanding of the mechanism of action and potential for clinical efficacy of
GSK2982772 in RA. After a screening period of up to 30 days, approximately 24 subjects will
be randomized to receive either GSK2982772 or placebo for 84 days (12 weeks), followed by a
follow-up period (28 days). The total duration of participation in the study will be
approximately 20 weeks from screening to the last study visit.
创建时间:
2024-11-26



