QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00581997

Enrollment

Registered

2007-12-28

Start date

2007-12-31

Completion date

Unknown

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis Secondary to Systemic Sclerosis

Keywords

Pulmonary fibrosis, systemic sclerosis

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

Interventions

DRUGQAX576

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame
- 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026