A Study of LY3337641 in Rheumatoid Arthritis

Summary

The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).

Timeline

Start

2016-08-22

Primary completion

2018-04-25

Completion

2018-08-15

Outcome

Missed primary endpoint

Stopped: “The trial was terminated after an interim analysis of efficacy and safety data did not warrant continuation of the trial.”

paper There was no statistically significant difference in ACR20 response between any dose of poseltinib and placebo at Week 12. PMID 33323529 ↗

registry analysis (superiority test); Part B: Placebo vs Part B: 5 mg LY3337641; p = 0.473; Regression, Logistic NCT02628028 ↗

registry analysis (superiority test); Part B: Placebo vs Part B: 10 mg LY3337641; p = 0.670; Regression, Logistic NCT02628028 ↗

registry analysis (superiority test); Part B: Placebo vs Part B: 30 mg LY3337641; p = 0.823; Regression, Logistic NCT02628028 ↗

Publications

• Genovese MC, Spindler A, Sagawa A, Park W, Dudek A, Kivitz A, Chao J, Chan LSM, Witcher J, Barchuk W, Nirula A. Safety and Efficacy of Poseltinib, Bruton's Tyrosine Kinase Inhibitor, in Patients With Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled, 2-part Phase II Study. J Rheumatol. 2021 Jul;48(7):969-976. doi: 10.3899/jrheum.200893. Epub 2020 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Poseltinib	Unknown	5 mg	Oral
Subject	Poseltinib	Unknown	10 mg	Oral
Subject	Poseltinib	Unknown	30 mg	Oral

Indications