QAX576:Safety, Tolerability, Efficacy, PD & PK in progressive IPF
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, multiple-dose, exploratory proof of concept study to assess the safety, tolerability, efficacy, pharmcodynamics and pharmacokinetics of QAX576 in patients with rapidly progressive idiopathic pulmonary fibrosis.
IRAS ID
72507
Contact name
Toby Maher
Sponsor organisation
Novartis
Eudract number
2010-020688-18
Clinicaltrials.gov Identifier
Research summary
Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that causes swelling and scarring of the lungs, but does not have a known cause, The damage causes the lung to stiffen and makes breathing more difficult. Idiopathic pulmonary fibrosis has a poor prognosis, and, to date, no proven effective therapies are available for its treatment beyond lung transplantation.QAX576 is a Monoclonal antibody. QAX576 can find and bind to specific molecules such as human Interleukin -13 (IL-13). IL-13 is produced by the immune system and may be involved in idiopathic pulmonary fibrosis. By blocking the action of IL-13, QAX576 may be able to help pulmonary fibrosis.Patients will be treated with QAX576 or placebo (placebo looks like a study drug but contains no medicine).The patient will have a 3 to 1 chance of being treated with either QAX576 or placebo: A 75% chance of getting QAX576 and a 25% chance of getting placebo. Patients will be asked to have one intravenous (IV) infusion every four weeks for 48 weeks. This IV infusion takes about 2 hours. Patients will receive 13 doses of study medication.In addition to taking blood samples to examine the Pharmacodynamics and pharmacokinetics of QAX576. Adverse events and concomitant medication will be documented throughout the study.About 40 patients, with mild to moderate, progressively worsening IPF, will join in this study at many locations in the United States and the United Kingdom.At least every 4 months Safety Parameters will be reviewed by the Data Monitoring Committee(DMC)depending on the occurrence of any safety-related findings the DMC may recommend review of safety and suspension/ and or dosing. Any significant recommendations affecting the conduct of the study will be communicated to the Competent Authorities and Ethics Committees as appropriate.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
11/LO/0448
Date of REC Opinion
29 Jun 2011
REC opinion
Further Information Favourable Opinion