Overview

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