QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

Novartis

Status and phase

Terminated

Phase 2

Conditions

Pulmonary Fibrosis Secondary to Systemic Sclerosis

Treatments

Drug: QAX576

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00581997

CQAX576A2201

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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