Efficacy and safety of Janus kinase 1/2 inhibitor KL130008 in active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase II trial.

ABSTRACT:

Background

KL130008 is a selective Janus kinase 1/2 inhibitor with encouraging preclinical efficacy. Phase I trials in healthy volunteers and patients with rheumatoid arthritis (RA) showed favorable pharmacokinetics, dose-dependent inhibition of phosphorylated signal transducer and activator of transcription 3, good tolerability, and no clinically meaningful pharmacokinetic interaction with methotrexate, supporting further evaluation in active RA.

Methods

In this double-blind, placebo-controlled phase II trial at 24 centers in China, RA patients were randomized (1:1:1:1) to receive placebo or KL130008 capsules (0.5, 1 or 2 mg) once daily for 12 weeks. Week 13-24, the placebo group was switched 1:1 to KL130008 at 0.5 mg or 1 mg, while other groups continued their original dos

SUBMITTER: Cheng Y 

PROVIDER: S-EPMC12801910 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature