Rheumatoid ArthritisPhase 3NCT06276998
A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis (COURAGE-RA)
A Phase 3 study testing LNK01001 in people with Rheumatoid Arthritis, run by Lynk Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- LNK01001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2023to 20 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 and above.
- Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months.
- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and baseline visit.
- Erythrocyte sedimentation rate (ESR) ≥ 28mm/h or 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.
- Have an inadequate response to ≥ 1 bDMARD.
Who cannot join
- Subjects who were prior exposure to Janus Kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib) and have evidence showing an inadequate response or intolerance.
- Subjects who received intra-articular, intramuscular, intravenous, trigger point or tender point, intracapsular, or intra-tendon injections of glucocorticoids 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-Blind Placebo-controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of LNK01001 (Zemprocitinib) in Patient With Moderate-to-Severe Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs (COURAGE-RA)
Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs).
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.
The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1.
Read the detailed description
This study includes a 35-day screening period; a 24-week randomized, double-blind, parallel-group, placebo-controlled treatment period (Period 1); a 52-week open label long-term extension period (Period 2); and a 28 to 35-day follow-up period (FU).
Participants who meet eligibility criteria will be randomized in a 1:1 ratio to two treatment groups:
Group 1: LNK01001 12 mg BID (Day 1 to Week 24)， LNK01001 12 mg BID (Week 24 and thereafter)
Group 2: Placebo (Day 1 to Week 24)， LNK01001 12 mg BID (Week 24 and thereafter)
Participants who complete the Week 24 visit (end of Period 1) will enter the extension portion of the study, Period 2, and continue to receive LNK01001 12 mg BID treatment. Starting at Week 12, rescue therapy is allowed if there's less than 20% improvement in both swollen joint count (SJC) and tender joint count (TJC) compared to Baseline. Starting at Week 24, initiation of or change in corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or adding or increasing doses in up to 2 csDMARDs (concomitant use of up to 2 csDMARDs except the combination of methotrexate and leflunomide) is allowed.
- Conditions
- Rheumatoid Arthritis
- Being tested
- LNK01001, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNK01001Drug
Capsule; Oral
PlaceboDrug
Capsule; Oral
| Study group | Role | What they receive |
|---|---|---|
| LNK01001 12 mg | Experimental | Period 1: Participants receive LNK01001 12 mg twice daily for 24 weeks. Period 2: Participants will continue on LNK01001 12 mg twice daily from Week 24 to Week 76. Receives: Drug: LNK01001 |
| Placebo / LNK01001 12 mg | Placebo comparator | Period 1: Participants receive a placebo twice daily for 24 weeks. Period 2: Participants will switch to receive LNK01001 12 mg twice daily from Week 24 to Week 76. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
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).
Measured: Baseline and Week 24
Secondary outcomes (8)
Change from Baseline in Disease Activity Score 28 (DAS28) (CRP) at week 24
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.
Measured: Baseline and Week 24
Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at week 24
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).
Measured: Baseline and Week 24
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at all visits.
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.
Measured: Baseline to Week 76.
Percentage of Participants with an American College of Rheumatology 70% (ACR70) Response at all visits.
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
- 70% improvement in 68-tender joint count;
- 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).
Measured: Baseline to Week 76.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at all visits.
Low disease activity. was defined as a DAS28 score less than or equal to 3.2.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.
Measured: Baseline to Week 76.
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at all visits
Clinical remission was defined as a DAS28 (CRP) score less than 2.6.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.
Measured: Baseline to Week 76.
Percentage of Participants with an American College of Rheumatology 20% (ACR20) Response at all visits (except week 24).
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 3. 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).
Measured: Baseline to Week 76 (except week 24).
Change from Baseline in the Severity of Morning Stiffness at all visits.
Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).
Measured: Baseline to Week 76.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start12 Dec 2023
- Primary completion22 Aug 2025
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lynk Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Wei, Study director, Lynk Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276998
- Sponsor's protocol ID
- LK001304
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of LNK01001 (Zemprocitinib) in Patient With Moderate-to-Severe Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs (COURAGE-RA)
- ClinicalTrials.gov ID
- NCT06276998
- Acronym / sponsor ID
- LK001304
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Lynk Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs).
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.
The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1.
Detailed description
This study includes a 35-day screening period; a 24-week randomized, double-blind, parallel-group, placebo-controlled treatment period (Period 1); a 52-week open label long-term extension period (Period 2); and a 28 to 35-day follow-up period (FU).
Participants who meet eligibility criteria will be randomized in a 1:1 ratio to two treatment groups:
Group 1: LNK01001 12 mg BID (Day 1 to Week 24)， LNK01001 12 mg BID (Week 24 and thereafter)
Group 2: Placebo (Day 1 to Week 24)， LNK01001 12 mg BID (Week 24 and thereafter)
Participants who complete the Week 24 visit (end of Period 1) will enter the extension portion of the study, Period 2, and continue to receive LNK01001 12 mg BID treatment. Starting at Week 12, rescue therapy is allowed if there's less than 20% improvement in both swollen joint count (SJC) and tender joint count (TJC) compared to Baseline. Starting at Week 24, initiation of or change in corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or adding or increasing doses in up to 2 csDMARDs (concomitant use of up to 2 csDMARDs except the combination of methotrexate and leflunomide) is allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNK01001 12 mg | Experimental | Drug: LNK01001Period 1: Participants receive LNK01001 12 mg twice daily for 24 weeks. Period 2: Participants will continue on LNK01001 12 mg twice daily from Week 24 to Week 76. |
| Placebo / LNK01001 12 mg | Placebo comparator | Drug: PlaceboPeriod 1: Participants receive a placebo twice daily for 24 weeks. Period 2: Participants will switch to receive LNK01001 12 mg twice daily from Week 24 to Week 76. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants aged 18 and above.
- Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months.
- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and baseline visit.
- Erythrocyte sedimentation rate (ESR) ≥ 28mm/h or 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.
Key exclusion criteria (5 listed)
- Subjects who were prior exposure to Janus Kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib) and have evidence showing an inadequate response or intolerance.
- Subjects who received intra-articular, intramuscular, intravenous, trigger point or tender point, intracapsular, or intra-tendon injections of glucocorticoids 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNK01001Capsule; Oral | Drug | LNK01001 12 mg |
| PlaceboCapsule; Oral | Drug | Placebo / LNK01001 12 mg |
Primary outcome
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Time frame: Baseline and Week 24
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 3. 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).
8 secondary outcomes
Change from Baseline in Disease Activity Score 28 (DAS28) (CRP) at week 24
Time frame: Baseline and Week 24
Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at week 24
Time frame: Baseline and Week 24
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at all visits.
Time frame: Baseline to Week 76.
Percentage of Participants with an American College of Rheumatology 70% (ACR70) Response at all visits.
Time frame: Baseline to Week 76.
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at all visits.
Time frame: Baseline to Week 76.
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at all visits
Time frame: Baseline to Week 76.
Percentage of Participants with an American College of Rheumatology 20% (ACR20) Response at all visits (except week 24).
Time frame: Baseline to Week 76 (except week 24).
Change from Baseline in the Severity of Morning Stiffness at all visits.
Time frame: Baseline to Week 76.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Wei study director
Lynk Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LNK01001 in people with Rheumatoid Arthritis, run by Lynk Pharmaceuticals Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.