QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

NCT00581997 | Terminated Phase 2

• 1 other identifier: CQAX576A2201
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pulmonary Fibrosis Secondary to Systemic Sclerosis

Keywords

Pulmonary fibrosis, systemic sclerosis

Outcome Measures

Primary Outcomes (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.

  throughout the study

Secondary Outcomes (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.

  throughout the study

Study Arms (2)

1

EXPERIMENTAL

QAX576

Drug: QAX576

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

QAX576 DRUG

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Related Links

• Results for CQAX576A2201 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Pulmonary Fibrosis; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: December 1, 2007
• Primary Completion: April 1, 2009
• Last Updated: December 19, 2020

Record last verified: 2012-05