Study of LW402 Tablets in Moderate to Severe Rheumatoid Arthritis

NCT06800157 | Completed Phase 2 DMC

• 1 other identifier: LW402-II-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase IIa study is designed to evaluate the dose-response relationship, efficacy, safety, and tolerability of LW402 tablets administered for 12 weeks in adult patients with active rheumatoid arthritis receiving background methotrexate (MTX) therapy.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in DAS28-CRP at Week 12

  The DAS28-CRP is a composite measure of rheumatoid arthritis disease activity ranging from 0.0 to 9.4, calculated using tender joint count (28 joints), swollen joint count (28 joints), Patient's Global Assessment of Disease Activity (0-100 mm), and C-reactive protein (mg/L). Higher scores indicate greater disease activity.

  12 Weeks

Secondary Outcomes (5)

• Proportion of patients achieving ACR20 response at Week 12

  12 Weeks

• Proportion of patients achieving ACR50 response at Week 12

  12 Weeks

• Proportion of patients achieving ACR70 response at Week 12

  12 Weeks

• Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12

  12 Weeks

• Incidence of treatment-emergent adverse events (TEAEs)

  16 Weeks

Study Arms (3)

LW402 50 mg

EXPERIMENTAL

LW402 50mg BID, combined with MTX

Drug: Drug: LW402; Drug: MTX

Drug: LW402 125mg

EXPERIMENTAL

LW402 125mg BID, combined with MTX

Drug: Drug: LW402; Drug: MTX

Placebo

PLACEBO COMPARATOR

LW402 placebo BID, combined with MTX

Drug: Other: placebo; Drug: MTX

Interventions

Drug: LW402 DRUG

Oral tablets administered BID

Drug: LW402 125mg; LW402 50 mg

Other: placebo DRUG

Placebo to match LW402 administered BID

Placebo

MTX DRUG

Background treatment with MTX once a week

Drug: LW402 125mg; LW402 50 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• The patient voluntarily accept and is able to follow the protocol procedures including medication and follow-up examination;
• Age from 18 to 65 years old (including critical value), male or female;
• Have a diagnosis of adult-onset rheumatoid arthritis (RA) as defined by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA;
• Diagnosisof moderately to severely active rheumatoid arthritis who also meets the following disease activity criteria at screening:
• swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) ;C-Reactive Protein (CRP) ≥ 10 mg/L or Eerythrocyte sedimentation rate（ESR）≥ 28 mm/h; DAS28-CRP\>3.2；
• Subjects had been on methotrexate (MTX) for ≥12 weeks and on a stable oral dose (7.5-25 mg/ week) of MTX for ≥4 weeks prior to randomization and are able to continue a stable dose of MTX during the study.

You may not qualify if:

• Suspected or confirmed allergy to investigational drugs (including excipient and similar drugs) ,and other serious allergic diseases (except RA) judged by the investigator that may impair the safety of the subjects;
• Had any inflammatory joint disease or autoimmune disease other than RA at screening (such as Gout, Reactive arthritis, Psoriatic arthritis, Spinal arthritis, Systemic lupus erythematosus, Mixed connective tissue diseases, etc.);
• Have a history of lymphoproliferative disease; or have a current malignancy or history of malignancy (except Cutaneous squamous cell carcinoma in situ, Basal cell carcinoma or cervical carcinoma in situ, which have not shown any signs of recurrence for more than 5 years after achieving complete remission following radical treatment);
• Have a history of major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell or bone marrow transplant;
• Patients with Active tuberculosis at screening should be excluded.After a minimum of 4 weeks of treatment with 0.3g qd of isoniazid(or other prophylactic anti-tuberculosis treatments) for latent tuberculosis infection, continued screening could be considered when the investigator reassessed that the risk was controlled;
• Presence of active infection, or have a history of: Systemic anti-infective treatment within 4 weeks prior to randomization; Sore throat, nasal congestion, acute upper respiratory tract infection, or systemic acute infection within 2 weeks prior to randomization; Presence of recurrent, chronic or other active infections in the screening period which may increase the risk of the subjects according to the evaluation of the investigators;
• Have a history of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex, or have a history of herpes zoster or herpes simplex within 2 months before randomization;
• Presence of other diseases at screening that may interfere with the study evaluation;
• Abnormal laboratory values at screening:
• Hemoglobin \<10.0g/dL（100.0g/L） for male or \< 9.0g/dL (90.0g/L) for female;WBC count \<3.0×109/L;Neutrophil count \<1.5×109/L; Platelet count \<100×109/L; Lymphocyte count \<0.5×109/L; Alanine transaminase (ALT) and/or Serum aspartate transaminase (AST) \>1.5 upper limit of normal (ULN); Serum creatinine \>1.5×upper limit of normal (ULN).
• Positive for hepatitis B surface antigen and/or positive for hepatitis B core antibody (except HBV DNA negative or less than 500IU/ml) , positive for hepatitis C virus (HCV) antibody, positive for anti-human immunodeficiency virus (HIV) antibody, or anti-syphilis spiral antibody (except for TP-Ab positive but RPR or TRUST negative) at screening；
• Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator , are clinically significant and indicate an unacceptable risk for the participant's participation in the study;
• Previous use of any of the following medications or treatments:
• Have received potent opioids within 1 week before randomization;
• Have received any JAK inhibitor within 2 weeks before randomization;

Sponsors & Collaborators

• Shanghai Longwood Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, 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 Design

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

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: January 29, 2025
• Study Start: February 27, 2023
• Primary Completion: May 26, 2024
• Study Completion: August 30, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-01

Locations

CN (1)