QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00581997
• Date of registration: 21/12/2007
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis
• Scientific 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
• Date of first enrolment: December 2007
• Target sample size: 8
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00581997
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Fibrosis Secondary to Systemic Sclerosis

Intervention(s)

Drug: Placebo

Drug: QAX576

Primary Outcome(s)

- 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(s)

- 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]

Secondary ID(s)

CQAX576A2201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors