Iguratimod in Systemic Sclerosis

• Status: Not yet recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital

Criteria

Inclusion Criteria:

• Diagnosis of systemic sclerosis (SSc), as classified using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.

• Diffuse Cutaneous Systemic Sclerosis (dcSSc) as defined by 2001 LeRoy and Medsger Disease duration ≤ 3 years (defined as time from the first non-Raynaud phenomenon manifestation).

• Agree to use effective contraception during the study period (women of childbearing age).

• Smokers agreed to quit smoking during the study.

• Ability to provide informed consent.

Exclusion Criteria:

• The following drugs have been used within one month before screening: including TNF-α inhibitors (continuous use for more than 14 days), IL-6 inhibitors, abatacept (continuous use for more than 14 days), JAK inhibitors (continuous use for more than 14 days).

• Used rituximab within 3 months before screening.

• SSc with tumor.

• People with various lung infections, asthma or other lung diseases such as bronchiectasis.

• For patients with severe heart, liver, kidney and other important organ dysfunction, the evaluation criteria are as follows: ALT or AST is greater than 2 times the upper limit of normal, or total bilirubin rises twice; CPK>400; Renal crisis, or hypertension of various causes (≥160/100mmHg) is not controlled; Creatinine clearance rate <30ml/min; White blood cell count<3×109/L; Hemoglobin <80g/L; Platelet count<60×109/L; Heart function level III-IV; PaO2<50mmHg in resting state; FEV1/FVC<0.7.

• In the period of acute or chronic infection (not including finger ulcer combined infection).

• A history of peptic ulcer or bleeding within 6 months before screening.

• People with allergies or multiple drug allergies.

• People with mental illness or other reasons who cannot cooperate with treatment.