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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Pirfenidone

Criteria

Inclusion Criteria:

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. 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