Back to resultsA Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
LNK01001 Dose A
LNK01001 Dose B
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
LNK01001 Dose A
LNK01001 Dose B
placebo/LNK01001 Dose A
placebo/LNK01001 Dose B
Arm Description
Participants will receive LNK01001 Dose A orally BID for up to 24 weeks.
Participants will receive LNK01001 Dose B orally BID for up to 24 weeks.
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.
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.
Outcomes
Primary Outcome Measures
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 68-tender joint count;
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).
Secondary Outcome Measures
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).
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 68-tender joint count;
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)
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
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
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.
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).
Full Information
NCT ID
NCT06099535
First Posted
October 10, 2023
Last Updated
October 24, 2023
Sponsor
Lynk Pharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT06099535
Brief Title
A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis Patients With Inadequate Response or Intolerance to csDMARDs
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
April 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lynk Pharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
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 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.
Group 1: LNK01001 Dose A BID (Day 1 to Week 12)， LNK01001 Dose A BID (Week 13 and thereafter)
Group 2：LNK01001 Dose B BID (Day 1 to Week 12)， LNK01001 Dose B BID (Week 13 and thereafter)
Group 3: Placebo (Day 1 to Week12) ， LNK01001 Dose A BID (Week 13 and thereafter)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LNK01001 Dose A
Arm Type
Experimental
Arm Description
Participants will receive LNK01001 Dose A orally BID for up to 24 weeks.
Arm Title
LNK01001 Dose B
Arm Type
Experimental
Arm Description
Participants will receive LNK01001 Dose B orally BID for up to 24 weeks.
Arm Title
placebo/LNK01001 Dose A
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
placebo/LNK01001 Dose B
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LNK01001 Dose A
Intervention Description
Capsules taken orally
Intervention Type
Drug
Intervention Name(s)
LNK01001 Dose B
Intervention Description
Capsules taken orally
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Capsules taken orally
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at week 12
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
20% improvement in 68-tender joint count;
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With an ACR50
Description
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
Title
Percentage of Participants With an ACR20
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
20% improvement in 68-tender joint count;
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
Title
Change From Baseline in Disease Activity Score 28 (DAS28)-CRP
Description
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
Time Frame
Week1,2,4,8,12
Title
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR
Description
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
Title
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI).
Description
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
Title
Percentage of Participants With an ACR70
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis
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