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Arthritis, RheumatoidPhase 2NCT06800157

Study of LW402 Tablets in Moderate to Severe Rheumatoid Arthritis

A Phase 2 study testing Drug: LW402 and MTX in people with Arthritis, Rheumatoid, run by Shanghai Longwood Biopharmaceuticals Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Drug: LW402 and MTX
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteChina
Study dates
27 Feb 2023to 30 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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；
  • 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.

Who cannot join

  • 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;
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  • 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;
  • Have received any drugs that may interact with this product within 4 weeks before randomization, such as potent inhibitors of CYP3A4 (such as ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, etc.), potent inducers of CYP3A4 (such as rifampicin);
  • Have received disease-modifying antirheumatic drugs (DMARDs) or biological agents other than MTX. before randomization:
  • Have received sulfasalazine, antimalarial drugs, penicillamine, oral gold salts, cyclosporine, azathioprine, cyclophosphamide, iguratimod, etc., within 4 weeks before randomization or no more than 5 half-life periods; Have received herbal medicines (including tripterygium wilfordii preparations, total glucosides of paeony, sinomenine and/or Chinese herbs) within 4 weeks before randomization; Have received Flunomide within 8 weeks before randomization; Have received TNF-α inhibitor (fusion protein) within 4 weeks, or received TNF-α inhibitor (monoclonal antibody) or abatacept within 12 weeks prior to randomization have received Tocilizumab within 10 weeks prior to randomization; Have received Rituximab within 24 weeks, or received another biologic agent with no more than 5 half-life periods before randomization.
  • Are currently receiving receiving non-steroidal anti-inflammatory drugs (NSAIDs) before randomization with an unstable dosing regimen within 4 weeks before randomization;
  • Are currently receiving corticosteroids at doses >10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids t within 4 weeks before randomization;
  • Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 4 weeks prior to randomization;
  • Have been enrolled in another clinical study within 4 weeks or been treated by the last dose of any investigational drug within 5 half-lives prior to randomization;
  • Have been exposed to a live/attenuated vaccine within 8 weeks prior to randomization or are expected to need/receive a live/attenuated vaccine during the course of the study;
  • Have a history of drug or alcohol abuse (defined as consuming more than 28 units of alcohol per week. 1 unit =285ml beer or 25ml spirits containing at least 40% alcohol or 1 glass of wine) within the last 6 months.
  • Have donated ≥300mL of blood within 4 weeks prior to screening (except physiological blood loss in female) or plan to donate blood during or within 4 weeks after the study;
  • Women and/or men of childbearing potential and their partners who refuse to use effective contraception from the time they sign the informed consent until 6 months after the last dose, or who are planning to have children, donate eggs (women) or donate sperm (men);
  • Female who is pregnant or breastfeeding;
  • Other situations which are not suitable for the study per Investigator judgment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: 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

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.

Being tested
Drug: LW402, Other: placebo, MTX
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug: LW402Drug

    Oral tablets administered BID

  • Other: placeboDrug

    Placebo to match LW402 administered BID

  • MTXDrug

    Background treatment with MTX once a week

Study groups in NCT06800157
Study groupRoleWhat they receive
LW402 50 mgExperimentalLW402 50mg BID, combined with MTX
Receives: Drug: Drug: LW402; Drug: MTX
Drug: LW402 125mgExperimentalLW402 125mg BID, combined with MTX
Receives: Drug: Drug: LW402; Drug: MTX
PlaceboPlacebo comparatorLW402 placebo BID, combined with MTX
Receives: Drug: Other: placebo; Drug: MTX

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 Weeks

Secondary outcomes (5)

  1. Proportion of patients achieving ACR20 response at Week 12

    ACR20 is defined as at least 20% improvement in tender and swollen joint counts and improvement in at least 3 of 5 additional core measures (Patient Global Assessment, Physician Global Assessment, Pain, Disability/HAQ, and CRP)

    Measured: 12 Weeks

  2. Proportion of patients achieving ACR50 response at Week 12

    ACR50 is defined as at least 50% improvement in tender and swollen joint counts and improvement in at least 3 of 5 additional core measures.

    Measured: 12 Weeks

  3. Proportion of patients achieving ACR70 response at Week 12

    ACR70 is defined as at least 70% improvement in tender and swollen joint counts and improvement in at least 3 of 5 additional core measures.

    Measured: 12 Weeks

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

    HAQ-DI assesses physical function in patients with rheumatoid arthritis. HAQ-DI has a score range from 0-3. Higher scores indicate greater disability.

    Measured: 12 Weeks

  5. Incidence of treatment-emergent adverse events (TEAEs)

    All adverse events occurring after the first dose of study drug are recorded and summarized.

    Measured: 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start27 Feb 2023
  3. Primary completion26 May 2024
  4. Study completion30 Aug 2024

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06800157
Sponsor's protocol ID
LW402-II-01
Status last verified
Jan 2025
First submitted
11 Oct 2024
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Drug: LW402 and MTX in people with Arthritis, Rheumatoid, run by Shanghai Longwood Biopharmaceuticals 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 7 inclusion and 28 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: finished, as of the sponsor's last update on 2 Oct 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline in DAS28-CRP at Week 12 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06800157.

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 2 Oct 2025.

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