QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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