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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
156
Capsules taken orally
Capsules taken orally
Capsules taken orally
Peking Union Medical College Hospital
Beijing, China
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. 20% improvement in 68-tender joint count; 2. 20% improvement in 66-swollen joint count; and 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: week 12
Percentage of Participants With an ACR50
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: 1.50% improvement in 68-tender joint count; 2.50% improvement in 66-swollen joint count; and 3.50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Week1,2,4,8,12
Percentage of Participants With an ACR20
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. 20% improvement in 68-tender joint count; 2. 20% improvement in 66-swollen joint count; and 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame: Week1,2,4,8
Change From Baseline in Disease Activity Score 28 (DAS28)-CRP
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity
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Time frame: Week1,2,4,8,12
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and ESR. Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity
Time frame: Week1,2,4,8,12
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI).
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Time frame: Week1,2,4,8,12
Percentage of Participants With an ACR70
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: 1\. 70% improvement in 68-tender joint count; 2. 70% improvement in 66-swollen joint count; and 3.70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Week1,2,4,8,12