QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis
Phase 2
Terminated
- Conditions
- Pulmonary Fibrosis Secondary to Systemic Sclerosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00581997
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 QAX576 QAX576 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method - Safety assessments including vital Signs, ECG's, Echocardiograms and blood draws. - The pharmacokinetics and pharmacodynamics of multiple doses of the drug will be assessed by blood draws at the 3 dosing visits. A blood sample will also be collected. throughout the study
- Secondary Outcome Measures
Name Time Method - The effect of the drug on biomarkers of pulmonary fibrosis and systemic sclerosis. - Pulmonary function tests. - Disease specific measurements, active hand extension, oral aperture, MRSS. throughout the study