Iguratimod in Systemic Sclerosis

Shanghai Jiao Tong University

Status: Unknown

Conditions: Systemic Sclerosis, Diffuse

Treatments: Drug: Iguratimod; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04515706

IGU

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Iguratimod

Experimental group

Description:

Iguratimod 25 twice a day (bid) on Week 1-48.

Treatment:

Drug: Iguratimod

Placebo

Placebo Comparator group

Description:

Placebo twice a day (bid) on Week 1-24, and Iguratimod 25 twice a day (bid) on Week 25-48.

Treatment:

Drug: Placebo

Drug: Iguratimod