a study of lnk01001 capsule in moderately to severely active rheumatoid arthritis

Conditions: 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.

this study includes a 35-day screening period; a 12-week randomized, double-blind, parallel-group, placebo-controlled treatment period (period 1); a 12-week double-blind period (period 2); and a 28 to 35-day follow-up period (fu). participants who meet eligibility criteria will be randomized in a ratio of 1：1：1 to 3 treatment groups in period 1， the placebo group will be rerandomized in a 1:1 ratio to lnk01001 dose a or lnk01001 dose b at week 13. 1. group 1: lnk01001 dose a bid (day 1 to week 12)， lnk01001 dose a bid (week 13 and thereafter) 2. group 2：lnk01001 dose b bid (day 1 to week 12)， lnk01001 dose b bid (week 13 and thereafter) 3. group 3: placebo (day 1 to week12) ， lnk01001 dose a bid (week 13 and thereafter) 4. group 4: placebo (day 1 to week12) ， lnk01001 dose b bid (week 13 and thereafter) participants who complete the week 12 visit (end of period 1) will enter period 2, and continue to receive lnk01001 dose a or dose b treatment. starting at week 12, rescue therapy is allowed.

Eligibility criteria:
inclusion criteria: * participants between ≥ 18 and ≤70 years of age. * diagnosis of ra for ≥ 3 months at screening visit who also fulfill the 2010 american college of rheumatology (acr)/ european league against rheumatism (eular) classification criteria for ra. * ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at screening and baseline visit. * high-sensitivity c-reactive protein (hscrp) ≥ uln at screening. * participants have been receiving csdmard therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. exclusion criteria: * subjects who are allergy to any component of the study drug. * subjects who are acr functional class iv or long-term bedridden/long-term wheelchair. * prior exposure to janus kinase (jak) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). * subjects who received intra-articular, intramuscular, intravenous, trigger point or tender point, intracapsular, or intra-tendon injections of glucocorticoids within 8 weeks before randomization. * current use of oral or inhaled glucocorticoids and the daily dose is \>10 mg of prednisone (or equivalent dose) or on a not stable dose within 4 weeks before randomization. * current use of non-steroidal anti-inflammatory drugs and on a not stable dose within 4 weeks before randomization. * subjects who received iguratimod treatment within 4 weeks before randomization. * subjects who received interferon treatment within 4 weeks before randomization. * current diagnosis of systemic inflammatory disease other than ra. * history of malignancy or current diagnosis of malignancy within 5 years before screening visit. * uncontrolled diabetes, hypertension, kidney disease, liver disease, severe heart disease. * subject with any major surgery within 4 weeks before randomization or planned major surgery during study; history of chronic pain that may affect study evaluation; previous recipient of an organ transplant. * any clinically significant laboratory or ecg abnormal value, as determined by the investigator, may interfere with the evaluation of the study results.