Interstitial Lung Disease Clinical Trials

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 on the ClinicalTrials.gov website:

Mallinckrodt MNK14344100:  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

Celgene CC-90001:  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 4 years, supported by HRCT scan and/or surgical lung biopsy.  Patients using any therapy targeted to treat IPF (Ofev or Esbriet) cannot qualify.  Additional inclusion/exclusion criteria apply.     

Primary Investigator:  Lake Morrison, MD   

Novartis VAY736:  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 a definite or probable 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, antidsDNA, 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 subject is not seropositive but has the presence of hilar/mediastinal adenopathy identified by HRCT scan of chest 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

IPF-PRO BI 1199.174: Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry is a prospective registry; collecting information regarding the natural history, health care interaction, patient reported questionnaires, data assessing quality of life, and treatment methods for patients with a diagnosis of IPF. This is strictly an observational study.  Patients will not receive any medication or intervention by participating in the IPF-PRO Registry.

To qualify for this study, patients must have a new diagnosis (within the last six months) of Idiopathic Pulmonary Fibrosis (IPF) at Duke. For patients who participate, this registry involves data abstraction from you medical record, blood samples, and quality of life questionnaires every six months.  The study visits will coordinate along with your normal doctor visits at Duke. Duke Clinical Research Institute will contact you every six months to conduct a telephone interview, confirm vital status, and document any recent hospitalizations.

Primary Investigator:  Lake Morrison, MD

PF-ILD BI 1199.247: A Phase III, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD).

This trial has met target enrollment and is no longer able to screen patients.

To qualify for this study patients must have a diagnosis of worsening ILD, other than IPF (Idiopathic Pulmonary Fibrosis). Patients must have experienced a decline in PFTs, worsening of respiratory symptoms, and/or an increase in the extent of fibrotic changes on chest imaging. Patients will be randomized using a 2:3 ratio to placebo or nintedanib.

Treatment Period: Part A of this trial last for 52 weeks and involves nine clinic visits. These visits will be every two weeks for six weeks and every six weeks thereafter.

Variable Treatment: Part B involves continuing treatment with visits every four weeks until the last patient enrolled meets 52 weeks of treatment.

Primary Investigator: Lake Morrison, MD  

PFF Registry: Pulmonary Fibrosis Foundation Patient Registry is an observational registry. This means participants will not receive any investigational treatments or drugs. Disease management and treatment decisions will be determined by the participant and the health care professional.

This registry has met target enrollment for this site and is no longer accepting patients.

To qualify for this study participants must have Interstitial Lung Disease (ILD). Participants will have data abstracted from their medical records every six months. An optional biorepository study will be offered to participants, which requires a one-time blood draw, the equivalent of 30mL (two tablespoons). Participants will be followed through medical records and will be requested to complete questionnaires related to quality of life during their normally scheduled pulmonary doctor visits.

Primary Investigator: Lake Morrison, MD

For additional information contact Shannon D. Tilley RRT, RCP, Clinical Research Coordinator for Interstitial Lung Disease, 919-668-8854.

Enroll in a Pulmonary Clinical Trial at Duke

Researchers in our division are investigating a variety of treatments and therapies to respond to lung disease. Click here for a list of current clinical trials.