A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis

NCT06099535 | Completed Phase 2

• 1 other identifier: LNK01001-2020-02RA
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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: 1. 20% improvement in 68-tender joint count; 2. 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).

  week 12

Secondary Outcomes (6)

• Percentage of Participants With an ACR50

  Week1,2,4,8,12

• Percentage of Participants With an ACR20

  Week1,2,4,8

• Change From Baseline in Disease Activity Score 28 (DAS28)-CRP

  Week1,2,4,8,12

• Change From Baseline in Disease Activity Score 28 (DAS28)-ESR

  Week1,2,4,8,12

• Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI).

  Week1,2,4,8,12

Study Arms (4)

LNK01001 Dose A

EXPERIMENTAL

Participants will receive LNK01001 Dose A orally BID for up to 24 weeks.

Drug: LNK01001 Dose A

LNK01001 Dose B

EXPERIMENTAL

Participants will receive LNK01001 Dose B orally BID for up to 24 weeks.

Drug: LNK01001 Dose B

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.

Drug: LNK01001 Dose A; Drug: placebo

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.

Drug: LNK01001 Dose B; Drug: placebo

Interventions

LNK01001 Dose A DRUG

Capsules taken orally

LNK01001 Dose A; placebo/LNK01001 Dose A

LNK01001 Dose B DRUG

Capsules taken orally

LNK01001 Dose B; placebo/LNK01001 Dose B

placebo DRUG

Capsules taken orally

placebo/LNK01001 Dose A; placebo/LNK01001 Dose B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lynk Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xiaofeng Zeng

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 25, 2023
• Study Start: November 18, 2021
• Primary Completion: December 29, 2022
• Study Completion: April 11, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

CN (1)