IPF Studies

Active:

GALAPAGOS NV: A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care (ISABELA1)

The main purpose of this study is to see how GLPG1690 works together with your current standard treatment on your lung function and IPF disease in general. The study will also investigate how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).

Principal Investigator: Diana Gomez Manjarres, MD

Sub-Investigator: Diya Patel, DO 

Clinicaltrials.gov identifier: NCT03711162

If you are interested in participating in this study or would like more information, please contact Rosie Kizza, RN at 352-273-7225


Closed:

Boehringer Ingelheim: A 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).

The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopatic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD..

Principal Investigator: Ibrahim Faruqi, MD

Clinicaltrials.gov identifier: NCT02999178


Rainier: A Phase 2, Randomized, Double-blind, Placebo Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects with Idiopathic Pulmonary Fibrosis.

This is a multi-center, randomized, double-blind, placebo controlled study for Simtuzumab (GS-6624) by Rainier to assess the efficacy of study treatment for IPF patients. The study will last up to 3.5 years. Throughout the study you will take the study drug, either the investigation drug or placebo, as a once weekly injection. The purpose is to evaluate if the investigational drug may slow the progression of IPF disease.

Principal Investigator: Ibrahim Faruqi, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01769196?term=RAINIER&rank=2


Stromedix: Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This is a multi-center, randomized, double-blind, placebo-controlled, multiple dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and impact on BAL and peripheral blood biomarkers of STX-100 in patients with IPF. Approximately 32 patients will be enrolled into 4 sequential ascending dose cohorts. Each cohort will include 8 patients randomized to receive either STX-100 (6 patients) or placebo (2 patients). Additional patients may be enrolled if deemed appropriate by the Data Safety Monitoring Board (DSMB).

Principal Investigator: Mark Brantly, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01371305?term=Stromedix&rank=2


BMS: Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis

The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).

Principal Investigator: Mark Brantly, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/study/NCT01766817?term=BMS+IPF&rank=1&show_locs=Y#locn


InterMune:  A Treatment Protocol to Allow Patients in the US with Idiopathic Pulmonary

Fibrosis Access to Pirfenidone 

The purpose of this study is to provide individuals who meet study inclusion criteria early access to pirfenidone.

Principal Investigator: Mark Brantly, MD

Clinicaltrials.gov link: http://www.clinicaltrials.gov/ct2/show/NCT02141087?term=InterMune&rank=20


InterMune: Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PIPF-012)

This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.

Principal Investigator: Mark Brantly, MD

ClinicalTrials.gov link: http://clinicaltrials.gov/ct2/show/NCT00662038?term=PIPF-012&rank=1


ASCEND: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.

The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.

Principal Investigator: Mark Brantly, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/results?term=IPF&pg=2



QAX576: A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF

This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.

Principal Investigator: Ibrahim Faruqi, MD

ClinicalTrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01266135