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Study of LW402 Tablets in Moderate to Severe Rheumatoid Arthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of LW402 Tablets in Moderate to Severe Rheumatoid Arthritis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Study to Evaluate the Efficacy, Safety, and Tolerability of LW402 Tablets in Patients With Moderate to Severe Active Rheumatoid Arthritis

NCT06800157•Shanghai Longwood Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent;
•2. The patient voluntarily accept and is able to follow the protocol procedures including medication and follow-up examination;
•3. Age from 18 to 65 years old (including critical value), male or female;
•4. 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;
•5. Diagnosisof moderately to severely active rheumatoid arthritis who also meets the following disease activity criteria at screening:
•* 6 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；
•6. 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.

Exclusion Criteria

•1. 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;
•2. 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.);
•3. 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);
•4. Have a history of major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell or bone marrow transplant;
•5. 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;
•6. 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;
•7. 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;
•8. Presence of other diseases at screening that may interfere with the study evaluation;
•9. 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).
+18 more criteria

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

February 27, 2023

Primary Completion Date

May 26, 2024

Completion Date

August 30, 2024

Last Updated

October 2, 2025

Enrollment

ACTUAL participants

Conditions

Arthritis, Rheumatoid

Interventions

Drug: LW402

DRUG

Other: placebo

DRUG

MTX

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of LW402 Tablets in Moderate to Severe Rheumatoid Arthritis

Inclusion Criteria

Exclusion Criteria

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