Idiopathic Pulmonary Fibrosis (IPF)
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This is a multi-center, randomized, double-blind, placebo-controlled, multiple dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and impact on BAL and peripheral blood biomarkers of STX-100 in patients with IPF. Approximately 32 patients will be enrolled into 4 sequential ascending dose cohorts. Each cohort will include 8 patients randomized to receive either STX-100 (6 patients) or placebo (2 patients). Additional patients may be enrolled if deemed appropriate by the Data Safety Monitoring Board (DSMB).
Contact Pamela Schreck at (352) 264-5195.
http://clinicaltrials.gov/ct2/results?term=IPF ClinicalTrials.gov Link: http://clinicaltrials.gov/ct2/show/NCT01371305
PI: Ibrahim Faruqi, MD
A Phase 2, Randomized, Double-blind, Placebo Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects with Idiopathic Pulmonary Fibrosis.
This is a multi-center, randomized, double-blind, placebo controlled study for Simtuzumab (GS-6624) by Rainier to assess the efficacy of study treatment for IPF patients. The study will last up to 3.5 years. Throughout the study you will take the study drug, either the investigation drug or placebo, as a once weekly injection. The purpose is to evaluate if the investigational drug may slow the progression of IPF disease.
Contact Pam Schreck/ Elaine Davis at (866)229-6312
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Mark Brantly, MD
PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.
Contact Pamela Schreck at (352) 294-5195
A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF
Principal Investigator: Ibrahim Faruqi, MD
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
Contact Carolyn Graisbery at (352) 273-8666.
ClinicalTrials.gov Link: http://clinicaltrials.gov/ct2/show/NCT01266135