Iguratimod in Systemic Sclerosis

NCT ID: NCT04515706

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-01-31

Brief Summary

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

Conditions

Systemic Sclerosis, Diffuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Iguratimod

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

Group Type: EXPERIMENTAL

Iguratimod

Intervention Type: DRUG

Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Iguratimod

Intervention Type: DRUG

Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect.

Placebo

Intervention Type: DRUG

Placebo of Iguratimod

Interventions

Iguratimod

Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect.

Intervention Type: DRUG

Placebo

Placebo of Iguratimod

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IGU

Identifier Type: -

Identifier Source: org_study_id