Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

Trial ID or NCT#

NCT01933334

Status

not recruiting iconNOT RECRUITING

Purpose

PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).

Official Title

The LOTUSS Trial: An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone When Administered to Patients With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Diagnosis of systemic sclerosis-related (SSc) confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis less than (\<) 7 years2. Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan3. Screening forced vital capacity (FVC) greater than equal to (\>=) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (DLCO) \>=40% of the predicted value4. At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate
Exclusion Criteria:
  1. 1. Clinically significant pulmonary hypertension2. Known underlying liver disease3. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux4. History of clinically significant asthma or chronic obstructive pulmonary disease5. Active infection6. Diagnosis of another connective tissue disorder7. Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention8. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD)9. Pregnancy or lactation10. Creatinine clearance \<40 milliliters per minute (mL/min)11. Prior use of pirfenidone12. Unsuitable for enrollment or unlikely to comply with study requirements
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Investigator(s)

Lorinda Chung
Lorinda Chung
Rheumatologist, Immunologist
Professor of Medicine (Immunology and Rheumatology) and, by courtesy, of Dermatology

View on ClinicalTrials.gov