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

Sponsored by:	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

MedlinePlus related topics: Pulmonary Fibrosis Scleroderma

U.S. FDA Resources

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

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 ]

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 ]

Estimated Enrollment:	24
Study Start Date:	December 2007
Estimated Primary Completion Date:	January 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

Contacts

Contact: Novartis

862 778 8300

Locations

United States, California
Novartis Investigator Site	Recruiting
Los Angeles, California, United States, 90095
Contact: NOVARTIS 862-778-8300
United States, Colorado
Nation Jewish Health	Recruiting
Denver, Colorado, United States, 80206
Contact: Morrison 303-270-2053
United States, Maryland
John Hopkins University	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Anderson 410-550-8582
United States, Massachusetts
Novartis Investigator Site	Recruiting
Boston, Massachusetts, United States, 02118
Contact: NOVARTIS 862-778-8300
United States, Texas
Novartis Investigator Site	Recruiting
Houston, Texas, United States, 77030
Contact: NOVARTIS 862-778-8300
United States, Wisconsin
Novartis Investigator Site	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: NOVARTIS 414-456-7022

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

NOVARTIS

Novartis investigator site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQAX576A2201
Study First Received:	December 21, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00581997
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Pulmonary fibrosis, systemic sclerosis

Study placed in the following topic categories:

Lung Diseases, Interstitial
Skin Diseases
Respiratory Tract Diseases
Fibrosis
Lung Diseases

Connective Tissue Diseases
Neoplasm Metastasis
Sclerosis
Scleroderma, Systemic
Pulmonary Fibrosis

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009