A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis

Summary

This study includes two periods. In Period 1, Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose B or a matching placebo for 12 weeks. Participants who receive a placebo in Period 1 will be re-randomized at Week 13 in a 1:1 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose B for 12 weeks (period 2). Participants who receive LNK01001 ( Dose A and Dose B) in Period 1 will maintain the treatment dose in Period 2.

Timeline

Start

2021-11-18

Primary completion

2022-12-29

Completion

2023-04-11

Outcome

Met primary endpoint

release “both low dose and high dose groups of LNK01001 improved patient conditions markedly and the efficacy exceeded all projected primary” simcere.com ↗

Drugs

Indications