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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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 years 2. Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan 3. 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 value 4. 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 hypertension 2. Known underlying liver disease 3. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux 4. History of clinically significant asthma or chronic obstructive pulmonary disease 5. Active infection 6. Diagnosis of another connective tissue disorder 7. Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention 8. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD) 9. Pregnancy or lactation 10. Creatinine clearance <40 milliliters per minute (mL/min) 11. Prior use of pirfenidone 12. Unsuitable for enrollment or unlikely to comply with study requirements


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