QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Pulmonary Fibrosis Secondary to Systemic Sclerosis

Intervention / Treatment
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* Drug: QAX576
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>QAX576 | Drug: QAX576<br> <br> |
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary fibrosis, systemic sclerosis