Clinical Research and Clinical Trials at Vanderbilt

The Idiopathic Pulmonary Fibrosis Center originated in 1998 with the enrollment of the first patient in the Avonex placebo-controlled trial for the treatment of Idiopathic Pulmonary Fibrosis (IPF).  Since that time the IPF Center has grown to become a nationally respected center of excellence for IPF healthcare, disease management, education, clinical trials, and lung transplantation.  Since our initial endeavor, our center has participated in 55 unique national and international clinical trials developed by pharmaceutical companies, NIH grants, and investigator initiated studies.  We were one of the initial members of both the IPFNet and the Pulmonary Fibrosis Foundation Care Center Network. 

The below describes clinical trials that are currently enrolling at our center, followed by studies that are expected to begin enrollment within the next few months. If you have questions about the studies or how to enroll in studies listed below, please contact Wendi Mason (wendi.mason@vumc.org or 615-343-7068).

Active Clinical Trials:

Celgene: CC-90001

Currently enrolling for IPF Patients currently not receiving FDA approved treatment of Esbriet or Ofev

Nationally, about 135 persons with IPF will enroll to receive either CC-90001 (at one of two doses) or placebo orally once daily for 24 weeks. More information about this drug and the study can be found on www.clinicaltrials.gov and search for NCT03142191.

 

VIP: Valgancyclovir with pirfenidone

Currently enrolling for those diagnosed with IPF who are currently prescribed and able to tolerate full dose pirfenidone (Esbriet) treatment. 

A trial being completed only at Vanderbilt, we expect to enroll 30 persons with IPF who are on full dose pirfenidone (Esbriet) therapy to receive either valgancyclovir or placebo orally once daily for 12 weeks.  More information about this drug study can be found on www.clinicaltrials.gov and search for NCT02871401.

 

EMD Serono: Abituzumab

Currently enrolling for patients with systemic scleroderma with related interstitial lung disease (SScILD)

Patients with SScILD will enroll to receive either Abituzumab (at one of two doses) or placebo intravenously once every four weeks for 100 weeks. More information about this drug and the study can be found on www.clinicaltrials.gov and search for NCT02745145. 

 

TRAIL-1: pirfenidone

Currently enrolling patients with RA-ILD.

Patients with RA-ILD will enroll to receive either pirfenidone or placebo orally three times daily with meals for 52 weeks. More information about this drug and the study can be found on www.clinicaltrials.gov and search for NCT02808871.

 

Biogen (SPIRIT): BG00011 vs. placebo.

Currently enrolling patients with IPF.

Patients with IPF will receive BG0001 or placebo by subcutaneous injection once weekly x 12 month. More information about this drug and the study can be found on www.clinicaltrials.gov and search for NCT03573505.

 

Novartis: VAY736 vs. placebo

Currently enrolling patients with IPF.

Patients with IPF will receive VAY736 or placebo by subcutaneous injection once montly x 12 month. More information about this drug and the study can be found on www.clinicaltrials.gov and search for NCT03287414.

 

Pulmonary Trials Cooperative: CleanUP IPF

Currently enrolling patients with IPF.

Patients with IPF will receive antibiotics (bactrim ds or doxycycline) daily x 2 years.  More information about this drug and the study can be found on www.clinicaltrials.gov and search for NCT02759120.

 

PULSE - iNO vs. placebo

Currently enrolling IPF patients.

Patients with IPF wearing oxygen >12 hours per day are randomized to wear a device administering placebo or inhaled nitric oxide x 16 weeks. More information about this drug and the study can be found on www.clinicaltrials.gov and search for NCT03267108.