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QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00581997
Recruitment Status : Terminated (Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date.)
First Posted : December 28, 2007
Last Update Posted : May 4, 2012
Information provided by (Responsible Party):
Novartis ( 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

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Secondary to Systemic Sclerosis Drug: QAX576 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2007
Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: QAX576
Placebo Comparator: 2
Drug: Placebo

Primary Outcome Measures :
  1. - 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 :
  1. - 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581997

Sponsors and Collaborators
Novartis Pharmaceuticals
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00581997     History of Changes
Other Study ID Numbers: CQAX576A2201
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pulmonary fibrosis, systemic sclerosis

Additional relevant MeSH terms:
Pulmonary Fibrosis
Lung Diseases
Neoplasm Metastasis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Neoplastic Processes
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases