- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06099535
A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Beijing, China
- Peking Union Medical College Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LNK01001 Dose A
Participants will receive LNK01001 Dose A orally BID for up to 24 weeks.
|
Capsules taken orally
|
Experimental: LNK01001 Dose B
Participants will receive LNK01001 Dose B orally BID for up to 24 weeks.
|
Capsules taken orally
|
Placebo Comparator: placebo/LNK01001 Dose A
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.
|
Capsules taken orally
Capsules taken orally
|
Placebo Comparator: placebo/LNK01001 Dose B
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.
|
Capsules taken orally
Capsules taken orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at week 12
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With an ACR50
Time Frame: Week1,2,4,8,12
|
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:
|
Week1,2,4,8,12
|
Percentage of Participants With an ACR20
Time Frame: Week1,2,4,8
|
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
Time Frame: Week1,2,4,8,12
|
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
Time Frame: Week1,2,4,8,12
|
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).
Time Frame: Week1,2,4,8,12
|
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
Time Frame: Week1,2,4,8,12
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaofeng Zeng, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LNK01001-2020-02RA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on LNK01001 Dose A
-
Lynk Pharmaceuticals Co., LtdCompletedAtopic DermatitisChina
-
Lynk Pharmaceuticals Co., LtdRecruitingAtopic DermatitisChina
-
Lynk Pharmaceuticals Co., LtdRecruiting
-
Lynk Pharmaceuticals Co., LtdCompleted
-
SeqirusDepartment of Health and Human ServicesRecruitingInfections | Virus Diseases | Respiratory Tract Infections | Influenza, Human | Infection ViralPhilippines, United States
-
Zhejiang UniversityCompletedHyperlipoproteinemia
-
AbbVieCompleted
-
Aventure ABCompletedBlood Glucose ResponseSweden
-
Sunshine Lake Pharma Co., Ltd.RecruitingProgressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)China
-
Ventyx Biosciences, IncTerminatedPsoriatic ArthritisUnited States, Bulgaria, Czechia, Germany, Hungary, Poland, Spain