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Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | QAX576 |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAX576 | Drug |
| ||
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Principal Investigator |
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| Label | URL |
|---|---|
| Results for CQAX576A2201 from the Novartis Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |