Interstitial Lung Disease Clinical Trials

This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts. For participants with non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected throughout the study for use in future research efforts.

This is a Phase 1b Double-Blind, Placebo-Controlled, Ascending Dose Trial: ORIN1001 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

The objective of the study is to evaluate the safety profile and tolerability of ORIN1001 alone and/or in combination with the local standard of care (SOC) in adult subjects with idiopathic pulmonary fibrosis.  This study design has three phases: screening (up to 28 days), double-blind treatment with 3 cycles (cycle 1- 28 days, cycle 2- 15 days, and cycle 3 15 days), and follow up (28 days after last dose).  The study medication is administered orally once daily for up to 84 days; ascending dose at 25 mg (cycle 1), 50 mg (cycle 2), or 100 mg (cycle 3).

To qualify for this study, patients must have a confirmed IPF diagnosis within 7 years of screening.   Standard of care (Esbriet or Ofev) is allowed but dose must be stable for 8 weeks.   Exclusions include:  IPF exacerbation within 3 months and full dose therapeutic anti-coagulation therapy.

This is a Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in patients with Idiopathic Pulmonary Fibrosis

The objective of the study is to evaluate the efficacy, safety, and pharmacokinetics of PRM-151 compared with placebo in patients with idiopathic pulmonary fibrosis (IPF).  This study design has three phases:  screening ( ), double-blind treatment (52 weeks), and follow up (4 weeks post last dose).  At the end of the 52-week treatment period, patients will be invited to enroll in an open-label extension study (Study WA42294) to receive treatment with PRM-151.  Patients who do not enroll in the OLE study will be followed up for an additional 4 weeks (to Week 56, for safety monitoring).  The study medication is administered by IV infusion over 50 to 70 minutes every 4 weeks. 

To qualify for this study, patients must have a confirmed IPF diagnosis.   Standard of care (Esbriet or Ofev) is allowed but dose must be stable for 4 weeks.   Exclusions include:  Acute infection within 4 weeks and Prednisone greater than 10 mg a day.

Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis.

This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled pilot study evaluating the efficacy and safety of Acthar gel in the treatment of pulmonary sarcoidosis. The objective of the study is to evaluate the efficacy and safety of H.P. Acthar® Gel (Acthar) in the treatment of pulmonary sarcoidosis. This study design has three phases: screening (up to 28 days),  double-blind treatment (24 weeks), and an optional open-label, which involves a 24 week extension. A follow-up visit will be conducted 4 weeks (± 2 days) after the last dose of study medication. This study medication is administered by subcutaneous injections two times a week.

To qualify for this study, patients must have a biopsy confirmed diagnosis of sarcoidosis greater than or equal to 1 year, able to administer self-injections, and demonstrate progression while on stable dose of Prednisone (or equivalent) 5mg -40 mg. 

A Phase II, double-blind, randomized, placebo-controlled trial evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily by mouth in patients with Idiopathic Pulmonary Fibrosis. 

To qualify for this study, patients must have an IPF diagnosis within 5 years, supported by HRCT scan and/or surgical lung biopsy.  Patients using Ofev to treat IPF cannot qualify.  Additional inclusion/exclusion criteria apply.     

A Phase II, subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with Idiopathic Pulmonary Fibrosis.  This study will investigate the safety and efficacy of VAY736 administered subcutaneously (s.c.) every 4 weeks for 48 weeks. Patients are randomized in a 1:1 ratio on top of local standard of care (SOC), to receive VAY736 or placebo.

To qualify for this study, patients must have an IPF diagnosis within 5 years.  The IPF diagnosis must be supported by HRCT scan and/or surgical lung biopsy.  In addition to an IPF diagnosis, patients must be seropositive for at least one of the following:   auto-antibodies:  RF. ANA, anti-dsDNA, anti-CCP, Scl-70, SSA (anti-La), anti-RNP, anti-Smith, Jo-1, PL-7, PL-12, EJ, OJ, SRP, Ku, Mi-2, anti-PM/Scl at screening visit.  If the patient is not seropositive but has the presence of hilar/mediastinal adenopathy identified on HRCT scan they will qualify. Patients can be taking therapy targeted to treat IPF (Ofev or Esbriet).  Additional inclusion/exclusion criteria apply.

Nitto Denko Juniper:   A phase II, randomized, double-blind, Placebo-Controlled study to evaluate the safety, tolerability, biological activity, and PK of ND-L02-s0201 in subjects with Idiopathic Pulmonary Fibrosis.

To qualify for this study, patients must have an IPF diagnosis within 5 years.  The IPF diagnosis must be supported by HRCT scan and/or surgical lung biopsy.  Patients can be taking therapy targeted to treat IPF (Ofev or Esbriet).  Additional inclusion/exclusion criteria apply.

RVT1601-CC-04 SCENIC:  A phase IIb randomized, double blind, placebo-controlled, dose-ranging, efficacy and safety study with inhaled RVT-1601 for the treatment of persistent cough in patients with IPF.

To qualify for this study, patients must have an IPF diagnosis with persistent cough for at least 8 weeks and not responded to antitussive therapy.  Patients can be taking therapy targeted to treat IPF (Ofev or Esbriet).  Additional inclusion/exclusion criteria apply.