NCT02858492

Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	GSK2982772 60 mg	GSK2982772 is available as a 30 mg white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.
DRUG	Placebo	Placebo is available as a white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.

Timeline

• Start date: 2016-10-17
• Primary completion: 2018-10-22
• Completion: 2018-10-22
• First posted: 2016-08-08
• Last updated: 2021-06-15
• Results posted: 2019-11-01

Locations

16 sites across 6 countries: Germany, Italy, Poland, Russia, Spain, United Kingdom