Interstitial Lung Disease

  • An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone when Administered to Patients with Systemic Sclerosis Related Interstitial Lung Disease (LOTUSS)

    PSSC–001 is a phase 2, open – label, randomized trial testing the safety and tolerability of pirfenidone at 2403 mg/d in patients with Systemic Sclerosis Related Interstitial Lung Disease (SSc – ILD). Participants will be monitored on pirfenidone alone or concurrently with a stable dose of oral cyclophosphamide or mycophenolate mofetil (MMF). Two dose titration schedules (2 vs. 4 wk) will be evaluated to determine if tolerability is enhanced with a slower titration schedule. Total exposure to pirfenidone for both groups is 16 wks. Eligible patients are males and females (18-70 yrs) with a confirmed diagnosis of SSc- ILD, forced vital capacity ≥ 50% and diffusion capacity of the lungs for carbon monoxide ≥ 40%. Eligible patients should either not be on any therapy for SSC ILD or be on a stable dose of MMF or oral cyclophosphamide, with a concurrent prednisone dose of < 10 mg QD. Ineligible patients include those with a history of pulmonary hypertension, COPD, evidence of significant aspiration, esophageal dysfunction limiting ability to swallow, prior use of tobacco, and history of asthma.

    PI: Nina Patel, MD (212) 342- 6924

    Contact: Nathalie Lissain (212) 342-3756

  • A Phase II Trial of Inhaled Carbon Monoxide for the Treatment of Idiopathic Pulmonary Fibrosis: The purpose of this 12-week phase II parallel-arm double-blind placebo-controlled randomized clinical trial of twice weekly inhaled CO for adults with IPF is to evaluate the safety and efficacy of inhaled CO for adults with IPF.
    PI: David Lederer, MD, MS
    Contact:
    Amisha Desai (212) 305-9434
  • 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

  • MedImmune CD-RI-CAT-354-1066: A Phase 2, Randomized, Dose Ranging Study to Evaluate the Efficacy of Tralokinumab in Adults with Idiopathic Pulmonary Fibrosis
    Study investigating a new medical therapy that seeks to understand the effect of two IV dosing regimens of tralokinumab on the change in percent-predicted FVC in adult subjects with mild to moderate Idiopathic Pulmonary Fibrosis (IPF). The study is a Phase II, dose-ranging, randomized, double-blind, parallel-arm, placebo controlled multi-centered trial. Participants will be randomly assigned in a 1:1:1 ratio to one of two doses of IV tralokinumab (400 or 800mg) or placebo every 4 weeks for 68 weeks for a total of 18 doses. The complete study will be approximately 90 weeks, which includes 4 follow-up visits.
    The inclusion criteria calls for participants who are age 50-79 with an IPF diagnosis for less than 4 years, and have an FVC between 50% and 90%, SpO2 on room air greater than 90% and a DLco between 30% and 90%.
    PI: David Lederer, MD, MS
    Contact:
    Tatiana Blue (212) 342-4167
  • 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
  • PIPF 016: A Randomized, Double Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
    A double blind, randomized, placebo-controlled trial evaluating the effect of oral Pirfenidone on the rate of decline of FVC (forced vital capacity) in patients with IPF. Results from 4 previous controlled trials suggest that Pirfenidone treatment is safe and well tolerated and results in clinically meaningful benefits in a variety of domains, including lung volume, exercise tolerance, and progression-free survival time in patients with IPF. Given the primacy of loss of lung volumes over time in patients with IPF, this protocol is intended to confirm that Pirfenidone 2403 mg/d reduces decline in FVC over 52 weeks compared with placebo in patients with IPF.
    PI: Nina Patel, MD
    Contact:
    Patricia Jellen (212) 305-1158
    Jaya Tiwari (212) 342-1518
    Nisha Philip (212) 305-7720
  • BIBF 1120: A 52 Week, Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, On Annual Forced Vital Capacity Decline, In Patients with Idiopathic Pulmonary Fibrosis (IPF)
    A double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, on annual decline in FVC in patients with IPF. The study drug, called BIBF 1120, is a small molecule antifibrotic kinase inhibitor (PDGF/R [platelet derived growth factor/receptor], FGF/R [fibroblast growth factor/receptor], VEGF/R [vascular endothelial growth factor/receptor]) being developed for the treatment of IPF. Theoretical and pharmacological models suggest that inhibition of these kinase receptors may interfere with the fibrotic signaling cascade. BIBF 1120 has been studied in a large Phase 2 trial in patients with IPF. In this first study the drug has shown promising effects in reducing the rate of decline of FVC and reducing exacerbation, as well as several other endpoints.
    PI: David Lederer, MD, MS
    Contact:
    Patricia Jellen (212) 305-1158
    Jaya Tiwari (212) 342-1518
    Nisha Philip (212) 305-7720
  • An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies
    PI: Nina Patel, MD
    Contact:
    Pat Jellen (212) 305-1158
    Not recruiting; roll over study