Scientists in the Duke Division of Pulmonary, Allergy, and Critical Care Medicine are striving to improve our understanding of the molecular mechanisms leading to interstitial lung disease (ILD).
Currently, Duke is collaborating on research to investigate the biologic and genetic basis of idiopathic pulmonary fibrosis. The ILD Clinic at Duke is participating in several multi-center clinical trials to test new and promising medications for treatment of IPF.
Current Clinical Trials
Each study has specific pulmonary function, radiographic, pathologic, and disease history requirements. A surgical lung biopsy is often not required.
Inclusion criteria vary among the studies, but all require a confident diagnosis of IPF (rather than other interstitial lung diseases, such as those associated with connective tissue disorders).
Similarly, exclusion criteria vary among studies. Of particular relevance, a significant amount of either radiographic emphysema or frank airways’ obstruction will preclude patients from participating.
Select a trial to read the full description and view on the ClinicalTrials.gov website:
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.
Principal Investigator: Lake Morrison, MD
Status: Open to Enrollment
IRB Number: Pro00048515
Clinical Trials.gov #: NCT01915511
Study Team Contact: See below
This is a Phase 3 randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety of belimumab 200 mg administered subcutaneously in adults with interstitial lung disease (ILD) associated with connective tissue disease (CTD) GSK221672_BEconneCTD-ILD (BElimumab for conneCtive Tissue Disease ILD)
The objective of the study is to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with interstitial lung disease (ILD) associated with connective tissue disease (CTD). This study design has three phases: screening (up to 42 days), double-blind, placebo-controlled treatment period (52 weeks), and follow up period (8 weeks after last dose). This study may have an Open Label Extension option for patients that complete the 52-week treatment period. The study medication is administered subcutaneously every week for 52- weeks.
To qualify for this study, patients must have a confirmed interstitial lung disease (ILD) associated with connective tissue disease (CTD) diagnosis with progression within 24 months.
Principal Investigator: Lake Morrison, MD
Status: Open to Enrollment
IRB Number: Pro00116730
Clinical Trials.gov #: NCT06572384
Study Team Contact: Shannon Tilley
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF) MTX-463-I201
The objective of the study is to evaluate the efficacy and safety of MTX-463 administered by IV infusion in adults with Idiopathic Pulmonary Fibrosis (IPF). This study design has three phases: screening (up to 28 days), double-blind, placebo-controlled treatment period (24 weeks), and follow up period (4 weeks after last dose). The study medication is administered my IV infusion every 4 weeks for 24- weeks.
To qualify for this study, patients must have a confirmed IPF diagnosis. Ofev, Esbriet, and Jascayd allowed; but not in combination.
Principal Investigator: Lake Morrison, MD
Status: Open to Enrollment
IRB Number: Pro00118417
Clinical Trials.gov #: NCT06967805
Study Team Contact: Lauren Gray
For additional information contact:
- Shannon D. Tilley RRT, RCP, Clinical Research Coordinator for Interstitial Lung Disease, 919-668-8854
- Lisa Holmes, Clinical Research Coordinator for Interstitial Lung Disease, 919-684-8726
- Lauren Gray, Clinical Research Coordinator for Interstitial Lung Disease, 919-684-7317
Historically Relevant Clinical Trials
Select a trial to read the full description and view on the ClinicalTrials.gov website:
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.
Primary Investigator: Craig Rackley, MD
ClinicalTrials.gov #: NCT03320070
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.
Primary Investigator: Lake Morrison, MD
ClinicalTrials.gov #: NCT03142191
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.
Primary Investigator: Lake Morrison, MD
ClinicalTrials.gov #: NCT03287414
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.
Primary Investigator: Lake Morrison, MD
ClinicalTrials.gov #: NCT03538301
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.
Primary Investigator: Lake Morrison, MD
ClinicalTrials.gov #: NCT03864328
For additional information contact:
Shannon D. Tilley RRT, RCP, Clinical Research Coordinator for Interstitial Lung Disease, 919-668-8854
Lisa Holmes, Clinical Research Coordinator for Interstitial Lung Disease, 919-684-8726