QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

A Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System Sclerosis

This study will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis

Inclusion Criteria:

• Men and women between the ages of 18 and 65 years with a confirmed diagnosis of pulmonary fibrosis secondary to systemic sclerosis
• Both men and women must be willing to use two forms of contraception. Additional information regarding this requirement is available at screening

Exclusion Criteria:

• Certain medical conditions may exclude patients from participation.
• Should not have participated in another clinical study within 4 weeks of study start
• Smokers are not eligible for participation
• Blood loss of donation of 400 mL or more within 2 months of study start
• Pregnant women or women who are breast feeding
• Past medical history of clinically significant ECG abnormalities
• Connective tissue disorders other than systemic sclerosis.
• Active infection or history of systemic parasitic infection
• History of immunodeficiency diseases, including a positive HIV test result
• History of drug or alcohol abuse within 12 months of study start
• Any condition that may compromise patient safety

Other protocol-defined inclusion/exclusion criteria may apply