Iguratimod in Systemic Sclerosis

NCT04515706 | Unknown

• 1 other identifier: IGU
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24

  Primary outcome is met if any participants experience a grade 3 or higher event prior to Week 24. A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03.

  Week 24

Secondary Outcomes (6)

• Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study

  Week 12, 24, 36, and 48

• Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study

  Week 12, 24, 36, and 48

• Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis

  Week 12, 24, and 48

• Scleroderma Clinical Trials Consortium Damage Index

  Week 24, 48

• Change in Modified Rodnan Skin Score (mRSS)

  Week 12, 24, 36, and 48

Study Arms (2)

Iguratimod

EXPERIMENTAL

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

Drug: Iguratimod

Placebo

PLACEBO COMPARATOR

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

Drug: Iguratimod; Drug: Placebo

Interventions

Iguratimod DRUG

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

Iguratimod; Placebo

Placebo DRUG

Placebo of Iguratimod

Placebo

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

iguratimod

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: January 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2024
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share