Status:
COMPLETED
A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis
Lead Sponsor:
Lynk Pharmaceuticals Co., Ltd
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 match...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2023
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06099535
Start Date
November 18 2021
End Date
April 11 2023
Last Update
October 25 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China