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
  • An exploratory multicenter, open-label, single arm study of the safety and tolerability of pirfenidone (Esbriet®) in combination with nintedanib (Ofev®) in patients with idiopathic pulmonary fibrosis

    Study investigating the safety of adding nentedanib to treatment with pifenidone in patients with Idiopathic Pulmonary Fibrosis (IPF).  Eligible patients must be receiving consistent treatment with pifenidone for at least 16 weeks on a stable dose.  Nintedanib will be added as an additional treatment for IPF (combination treatment) for 24 weeks.  This is a phase IV, open-label, single armed trial. Participants will have center visits weekly for the first 4 weeks, and biweekly until 24 weeks.

    PI: Nina Patel, MD
    Contact:
    Allison Wolf (212) 342-4412

  • A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’(SSc-ILD)

    Study investigating the safety and efficacy of nintedanib in adult patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD). This is a phase III, randomized, double-blind, placebo controlled trial. Participants will be randomly assigned in a 1:1 ratio to either nintedanib treatment or placebo orally for 52 or more weeks with center visits every 2 weeks for the first 6 weeks of treatment, every 6 weeks until 36 weeks, and every 8 weeks until 52 weeks. 

    PI: Nina Patel, MD
    Contact:
    Allison Wolf (212) 342-4412