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)

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

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

Who is eligible to participate?

Inclusion Criteria: 1. Diagnosis of SSc confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis <7 years 2. Diagnosis of SSc-ILD based on an HRCT scan 3. Screening FVC ≥50% of the predicted value, and screening DLCO ≥40% of the predicted value 4. At study entry, the patient either is not taking SSc-ILD medication or is taking cyclophosphamide or mycophenolate mofetil Exclusion Criteria: 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 mL/min 11. Prior use of pirfenidone 12. Unsuitable for enrollment or unlikely to comply with study requirements.

Last updated:

3/27/2014

NCT ID:

NCT01933334

IRB Number:

13-005205