Active Clinical Trials and Investigational Research in IPF
 

IPFnet PANTHER study revised, Click Here for urgent information.

Researchers are developing and testing a variety of new ways to treat IPF. These approaches target the various steps in the disease process. Therapies under investigation include:

  • Antifibrotic or antifibrogenic agents (such as Pirfenidone, interferon and certain blood-pressure-lowering medications) to suppress the scarring process
  • Antioxidants (such as N-acetylcysteine) to prevent damage to lung tissue
  • Monoclonal antibodies to inhibit “bad” cytokines (protein growth factors, such as TGF-beta, TNF-Alpha, or CTGF, that activate inflammation)

Active Clinical Trials

Please note that this is not a comprehensive list. Visit www.coalitionforpf.org for information on new research programs or contact the departments of pulmonary and critical care medicine at the medical schools of local universities for current IPF studies.

Clinical trials are being conducted to better understand how pulmonary fibrosis develops and to advance the treatment of IPF. In a clinical trial, healthcare providers use a new treatment for patients to determine if it is safe and effective. These studies investigate the effectiveness of vaccines, new drugs, or new ways of using known treatments. A new drug, for example, might be tested to see if patients live longer than they would without the drug. Not all patients in a clinical trial will receive the new treatment-often these studies compare patients given the new treatment with patients given a placebo (sugar pill) or standard treatment. For more information on clinical trials, please consult your physician.

Please note that you do not necessarily need to live in the same city as the principal investigator (the person managing the clinical trial) in order to participate. Active clinical trials include:

PHASE III TRIALS – CURRENTLY RECRUITING

  • Thalomid (Thalidomide) – Manufactured by Celgene: A Phase III, double-blind, placebo-controlled safety and efficacy study investigating the Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis with Thalidomide. Please visit www.clinicaltrials.gov and search “IPF” for a complete description of this trial, including inclusion/exclusion criteria. The study is sponsored by Johns Hopkins Medical Center (Baltimore,MD). Please call 410-550-4764 for more information. Study Completed

PHASE III CLINICAL TRIALS – NOT RECRUITING

  • Pirfenidone – Manufactured by Intermune: A Phase III, double-blind, placebo-controlled trial to evaluate the treatment effect of pirfenidone on change in a lung function measure (percent predicted forced vital capacity, or %FVC) and to evaluate the safety of treatment with pirfenidone compared with placebo. For a complete description of the study, including participating sites in the United States and internationally, please go directly to http://www.ascendtrial.com/trial_center or www.clinicaltrials.gov
  • BIBF 1120 – Manufactured by Boehringer Ingelheim: A Phase III, double-blind trial in patients with PF to investigate the effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline. A primary outcome measure will be the annual rate of decline in in FVC over 32 weeks. For further information on this study, please visit www.clinicaltrials.gov

PHASE II CLINICAL TRIALS – RECRUITING

  • BMS-986020 (Lysophosphatidic Acid Receptor Antagonist – Manufactured by Bristol-Myers-Squibb: A phase II, double-blind, placebo-controlled trial to determine if BMS-986020 will reduce the decline in forced vital capacity (FVC)  and be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).  To learn more, please go directly to: http://www.bms.com/studyconnect/Pages/ProtocolPage.aspx?govid=IM136-003,NCT01766817 or www.clinicaltrials.gov.   There are multiple participating locations throughout the United States.
  • MedImmune – A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults with Idiopathic Pulmonary Fibrosis. MedImmune is now enrolling for a clinical trial in patients with IPF. The study is investigating the effect of a drug called Tralokinumab on lung function in patients with mild to moderate IPF. Tralokinumab is a monoclonal antibody the blocks the action of a protein called IL-13 which is involved in wound healing and scarring after lung injury.  IL-13 has been found to be increased in the lungs of some patients with IPF.  If you would like to learn more about the study and are interested in taking part, further information including eligibility criteria is available at http://clinicaltrials.gov/ct2/show/NCT01629667. To learn more call toll free  1-855-498-5565.
  • Genentech is now enrolling for an active Phase 2 trial. Lebrikizumab – developed by Genentech/Roche – Lebrikizumab is a humanized monoclonal antibody targeting the protein IL-13.   The phase II study (RIFF) is designed to evaluate the safety and efficacy of lebrikizumab in patients with Idiopathic Pulmonary Fibrosis.  The primary outcome measure for the study is Progression Free Survival. Further information on the study including inclusion/exclusion criteria is available at www.clinicaltrials.gov and directly at http://www.clinicaltrials.gov/ct2/show/NCT01872689
  • FibroGen is enrolling for an active Phase II trial of FG-3019. FG-3019 is a human monoclonal antibody acting upon connective tissue growth factor. The Phase II study will measure the safety, tolerability and efficacy of the drug. Further information on the study is available at http://clinicaltrials.gov/ct2/show/NCT01890265 – Please also note that FibroGen is offering extended treatment for individuals in the earlier study – contact your Study Coordinator for more information or Loredie Lugos, RN, Clinical Program Manager at FibroGen (415-978-1353); llugos@fibrogen.com.
  • STX-100 – (Stromedix, Inc.): STX-100 is a monoclonal antibody being developed for the treatment of idiopathic pulmonary fibrosis (IPF). This multi-center, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of STX-100 in patients with IPF. The study began recruitment in Q4 ’11 and will enroll patients at sites across the United States. A complete description of the study is available at ClinicalTrials.gov.  Please refer to identifier: NCT01371305(http://clinicaltrial.gov/ct2/show/NCT01371305). For more information please contact Emily Graham at Emily.Graham@covance.com (Phone: 734-369-3873) or Kris Hermanson at Kris.Hermanson@covance.com (Phone: 608-310-4086).
  • Simtuzumab (formerly GS-6624 and AB004) developed by Gilead Sciences, Inc. – A Phase 2 drug candidate (humanized monoclonal antibody targeting the human LOXL2 protein) being evaluated for patients with idiopathic pulmonary fibrosis (IPF).  RAINIER is an ongoing Phase 2 study designed to evaluate the safety and efficacy of simtuzumab in patients with IPF.  Further information on the study including inclusion/exclusion criteria is available at www.clinicaltrials.gov and directly at http://www.clinicaltrials.gov/ct2/show/NCT01769196?term=simtuzumab&rank=1.   Please refer to this study by its ClinicalTrials.gov identifier: NCT01769196.

  • RISE-IIP trial.  Bayer HealthCare Pharmaceuticals is sponsoring a Phase II randomized, double-blind, placebo-controlled clinical trial to investigate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (IIP) including idiopathic pulmonary fibrosis (IPF). Patients must be between 18 to 80 years of age at screening and fulfill other eligibility criteria, including diagnosis of pulmonary hypertension confirmed by a right heart catheter. For more information, please go to ClinicalTrials.gov and use the following identifier: NCT02138825.  You may also contact Bayer Clinical Trials via email at: clinical-trials-contact@bayerhealthcare.com or call for trial location information (Phone Menu Options ’3′ or ’4′)  (+)1-888-842-2937

PHASE II CLINICAL TRIALS – NOT RECRUITING

  • FG-3019 — Manufactured by FibroGen, Inc. phase 2 study of FG-3019 (therapeutic antibody against connective tissue growth factor) for patients with IPF. The study is a Phase 2a, Open-Label, Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis. Enrollment is closed. Further information on the study is available at www.clinicaltrials.gov and directly at http://www.clinicaltrials.gov/ct2/show/NCT01262001?term=FG-3019&rank=6. Please refer to this study by its ClinicalTrials.gov identifier: NCT01262001. The study is sponsored by FibroGen. Please call Loredie Lugos, RN, BSN at 415-978-1353 or email at llugos@fibrogen.com for more information.

PHASE I CLINICAL TRIALS – RECRUITING

  • Combined PEX, Rituximab and Steroids in Acute IPF Exacerbations  – University of Pennsylvania. A Phase I/II study to assess the feasibility and safety of combined plasma exchange (PEX), rituximab, and conventional corticosteroid administration on the outcome of hospitalized patients with acute IPF exacerbations. The study will monitor indices of respiratory and cardiovascular function during the treatment interval and compare survival with historical controls.   Contact:  Nydia Chien, MSN, RN at 412-682-1626 or chienn@upmc.edu.  Refer to Trial NCT01266317.
  • SAR – Manufactured by Sanofi. To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period as well and efficacy as measured on pulmonary function tests (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers.  Visit Clinical Trials.gov for list of sites, refer to NCT01529853.  For site locations, use: Contact-US@sanofi.com.

ACTIVE PHASE I TRIAL – NOT RECRUITING

  • Aerosol Interferon-gamma - New York University School of Medicine.  Phase I study of effect of giving interferon-gamma as a nebulized mist directly into the lungs to affect the immune system in a way that decreases fibrosis.  Contact is Rany Condos, MD, Assistant Professor of Medicine, New York University School of Medicine, 718-278-6595.  Clinical Trials.gov reference:  NCT00563212.

COMPLETED TRIALS:

  • IW001 – Manufactured by Immuneworks. A phase I study of the safety and tolerability of 3 doses of IW001 per day in patients with IPF over a 24 week treatment period. To explore the biologic effects of IW001 on T-cell and B-cell reactivity. This study will also explore relationships between Collagen V reactivity and clinical measures of lung function in patients with IPF
  • CNTO 888 (Manufactured by Centocor, Inc.): A Phase 2, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously. The primary objective is to determine the efficacy (as measured by pulmonary function) and safety of CNTO 888 in patients with IPF. The secondary outcome measures are to assess the effect of CNTO 888 on measures of disease progression, patient reported outcomes, functional capacity and health-related quality of life, and to assess the pharmacokinetics and pharmacodynamics of CNTO 888 in IPF. Study Completed
  • PRM-151 – Manufactured by Promedior, Inc. A phase 1b study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of IV PRM-151 in patients with idiopathic pulmonary fibrosis has initiated in the US and the Netherlands. PRM-151 is being developed for potential therapeutic uses to prevent, treat, and reduce fibrosis in a number of disease settings.

TERMINATED:

  • QA576 – Manufactured by Novartis – A phase II double-blind, placebo-controlled trial to demonstrate the efficacy and safety of QAX576, as well as changes in FVC . The trial is currently recruiting. The study will evaluate time to clinical worsening, exacerbation of PF, progression of disease and pharmacokinetics of QAX576. For a complete description of the study and a list of the sites where it is being conducted, please go to clinicaltrials.gov

Investigational Research

The National Institutes of Health (NIH) offers an informative web page at www.clinicaltrials.gov for those interested in identifying IPF-related research at medical centers across the United States. It represents the most up-to-date research information for patients including trial sites, patient inclusion/exclusion criteria, and contact information for each trial. For further information please visit www.clinicaltrials.gov, and enter ‘pulmonary fibrosis’ or ‘IPF’ in the “Search Clinical Trials” area of the home page.

Familial Pulmonary Fibrosis Study – National Jewish Health
The purpose of this study is to investigate inherited genetic factors that play a role in the development of familial pulmonary fibrosis and to identify a group of genes that predispose individuals to develop pulmonary fibrosis. This investigation seeks to identify a group of genetic loci that play a role in the development of familial interstitial pneumonia (FIP or FPF), where 2 or more cases of IIP are seen within a family. To be eligible for this study, patients must have at least 2 members of the family diagnosed with Idiopathic Interstitial Pneumonia (IIP). The patient may be included in this number and does not have to live near the centers affiliated with the study. If you wish to join this study, please go to http://www.clinicaltrials.gov/ct2/show/study/NCT01088217?term=pulmonary fibrosis&rank=3 for further information or contact Janet Talbert at National Jewish Medical Center (1-800-423-8891 X 1022). This study is ongoing.

Peripheral Blood Biomarkers in Idiopathic Interstitial Pneumonias – Duke University Medical Center
The current diagnostic tools for IIP are inadequate. In addition to inaccurate diagnosis, they are very costly, and often result in delayed diagnosis and treatment. The challenge(s) we intend to address in this proposal is to improve the accurate and early diagnosis of idiopathic interstitial lung pneumonia (IIP), and to improve the ability to differentiate the subtypes of idiopathic interstitial pneumonias (IIPs) by developing peripheral blood biomarkers. The Broad Challenge Area addressed in this proposal is Biomarker Discovery and Validation, and the Specific Challenge Topic is 03-HL-101 (Identify and validate clinically relevant, quantifiable biomarkers of diagnostic and therapeutic responses for blood, vascular, cardiac, and respiratory tract dysfunction). For further information please go to http://www.clinicaltrials.gov/ct2/show/NCT01151527?term=pulmonary fibrosis&intr=pulmonary fibrosis blood biomarkers&rank=1 or contact Raven Kidd at Duke University raven.kidd@duke.edu
This study is ongoing.

IPFnet
The IPFnet is a national clinical research trial program of vital interest to the PF community. If you or someone in your family would like to participate in an IPFnet trial, please contact the appropriate center for you using the contact names and numbers listed on www.ipfnet.org or www.coalitionforpfor.org.

For information only, these studies have been completed:

  • The PANTHER-IPF: Prednisone, Azathioprine, and N-Acetylcysteine: PFnet PANTHER is now closed to enrollment.
  • The ACE-IPF: Anticoagulant Effectiveness in Idiopathic Pulmonary Fibrosis trial is investigating whether treatment with warfarin improves clinical outcome in subjects with IPF. The study is a 2-arm study with a 1 to 1 randomization to Warfarin or placebo. This study has now been completed.