Back to resultsQAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis
Primary Purpose
Pulmonary Fibrosis Secondary to Systemic Sclerosis
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
QAX576
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Fibrosis Secondary to Systemic Sclerosis focused on measuring Pulmonary fibrosis, systemic sclerosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
QAX576
Placebo
Outcomes
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.
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.
Full Information
NCT ID
NCT00581997
First Posted
December 21, 2007
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00581997
Brief Title
QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date.
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis Secondary to Systemic Sclerosis
Keywords
Pulmonary fibrosis, systemic sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
QAX576
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
QAX576
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
- 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 Measure Information:
Title
- 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=14398
Description
Results for CQAX576A2201 from the Novartis Clinical Trials website
Learn more about this trial
QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis
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