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

Completed · Phase 2

Conditions studied: Systemic Sclerosis

In brief

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).

Key facts

Study ID

NCT01933334

Run by

Genentech, Inc.

People needed

63

Starts

2013-10-01

Expected to finish

2014-09-01

Last updated by the study team

2016-08-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan
• 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
• At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate

You may not qualify if…

• Clinically significant pulmonary hypertension
• Known underlying liver disease
• Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux
• History of clinically significant asthma or chronic obstructive pulmonary disease
• Active infection
• Diagnosis of another connective tissue disorder
• Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention
• History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD)
• Pregnancy or lactation
• Creatinine clearance <40 milliliters per minute (mL/min)
• Prior use of pirfenidone
• Unsuitable for enrollment or unlikely to comply with study requirements

Where it is running

• Mayo Clinic, Scottsdale — Scottsdale, Arizona, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Stanford University School of Medicine — Redwood City, California, United States
• University of California, San Francisco — San Francisco, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Northwestern University, Chicago — Chicago, Illinois, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia University — New York, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Toledo — Toledo, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University South Carolina — Charleston, South Carolina, United States
• University of Texas, Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• St. Joseph's Healthcare — Hamilton, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Università di Torino — Orbassano, Turin, Italy
• University of Florence — Florence, Italy

Full record on ClinicalTrials.gov

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