Interstitial Lung Disease

  • A randomized, double-blind, placebo-controlled phase II study to investigate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (RISE-IIP)

    Study investigating the safety and efficacy of riociguat in adults with symptomatic pulmonary hypertension. This is a phase II, randomized, double-blind, placebo controlled trial. Participants will be randomly assigned in a 1:1 ratio to either riociguat or placebo orally for 26 weeks with center visits every 2 weeks during the 10 week dose titration phase and every 4 weeks henceforth. After 26 weeks, patients will enter the long-term extension phase and all be placed on riociguat.
    PI: David Lederer, MD, MS
    Contact:
    Amika McBurnie (212) 342-1518

  • BI 1199.33: An open-Label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)
    PI: David Lederer, MD, MS
    Contact:
    Tatiana Blue (212) 342-4167
  • Not recruiting, Roll over study

  • A Phase 2, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis
    Study investigating a new medical therapy that seeks to understand the effect of simtuzumab on progression free survival (PFS) as determined by a categorical decline in forced vital capacity (FVC) in adult subjects with mild to moderate Idiopathic Pulmonary Fibrosis (IPF). The study is a Phase II, randomized, double-blind, placebo controlled multi-center trial. Participants will be randomly assigned in a 1:1 ratio to either simtuzumab or placebo by subcutaneous injection for 78 weeks with center visits every 4 weeks. Since this is an event-driven study, the treatment period will conclude once the requisite number of events have occurred, or at 182 weeks, whichever comes first.
    PI: David Lederer, MD, MS
    Contact:
    Tatiana Blue (212) 342-4167