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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNK01001 Dose A | Experimental | Participants will receive LNK01001 Dose A orally BID for up to 24 weeks. |
|
| LNK01001 Dose B | Experimental | Participants will receive LNK01001 Dose B orally BID for up to 24 weeks. |
|
| placebo/LNK01001 Dose A | Placebo Comparator | Participants will receive a placebo orally BID for 12 weeks in Period 1. Participants will be re-randomized at Week 13 in a 1:1 ratio to receive LNK01001 Dose A orally BID for up to 24 weeks. |
|
| placebo/LNK01001 Dose B | Placebo Comparator | Participants will receive a placebo orally BID for 12 weeks in Period 1. Participants will be re-randomized at Week 13 in a 1:1 ratio to receive LNK01001 Dose B orally BID for up to 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNK01001 Dose A | Drug | Capsules taken orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
20% improvement in at least 3 of the 5 following parameters:
| week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zeng | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| LNK01001 Dose B |
| Drug |
Capsules taken orally |
|
| placebo | Drug | Capsules taken orally |
|
| 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:
20% improvement in at least 3 of the 5 following parameters:
| 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 | 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 | 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. | 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:
| Week1,2,4,8,12 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |