QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00581997

Purpose

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

Condition	Intervention	Phase
Pulmonary Fibrosis Secondary to Systemic Sclerosis	Drug: QAX576 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Fibrosis Scleroderma

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

- 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. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

- 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. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	December 2007
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental QAX576	Drug: QAX576
2: Placebo Comparator Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581997

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CQAX576A2201
Study First Received:	December 21, 2007
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00581997 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Pulmonary fibrosis, systemic sclerosis

Additional relevant MeSH terms:

Lung Diseases, Interstitial
Pulmonary Fibrosis
Lung Diseases
Fibrosis
Skin Diseases
Sclerosis
Neoplastic Processes

Neoplasms
Pathologic Processes
Respiratory Tract Diseases
Neoplasm Metastasis
Connective Tissue Diseases
Scleroderma, Diffuse
Scleroderma, Systemic

ClinicalTrials.gov processed this record on February 08, 2010