This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 4 for:    promedior
Previous Study | Return to List | Next Study

A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Promedior, Inc.
ClinicalTrials.gov Identifier:
NCT02550873
First received: August 27, 2015
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with IPF.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Biological: PRM-151 Other: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Resource links provided by NLM:


Further study details as provided by Promedior, Inc.:

Primary Outcome Measures:
  • Forced vital capacity (FVC)% predicted change from baseline [ Time Frame: 0 to 28 weeks ]

Secondary Outcome Measures:
  • Mean change from baseline in volume of interstitial lung abnormalities (ILA) on high-resolution computed tomography (HRCT) (ml) [ Time Frame: 0 to 28 weeks ]
    • Mean change from baseline in volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing, using quantitative imaging software

  • Mean change from baseline in % of total lung volume of interstitial lung abnormalities (ILA) on HRCT (%) [ Time Frame: 0 to 28 weeks ]
    • Mean change from baseline in % of total lung volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing, using quantitative imaging software

  • Mean change from Baseline in volume of normal lung on HRCT (ml) [ Time Frame: 0 to 28 weeks ]
  • Mean change from Baseline in % of total lung volume of normal lung on HRCT (%) [ Time Frame: 0 to 28 weeks ]
  • Correlation between mean change from Baseline in FVC % predicted and mean change from Baseline in interstitial lung abnormalities (ILA) [ Time Frame: 0 to 28 weeks ]
    • Correlation between mean change from Baseline in FVC % predicted and mean change from Baseline in volume of parenchymal features on HRCT representative of interstitial lung abnormalities (ILA), including ground glass density, reticular changes, and honeycombing by quantitative imaging software.

  • Incidence of adverse events (AEs) [Safety and Tolerability] [ Time Frame: 0 to 28 weeks ]
  • Incidence of serious adverse events (SAEs) [Safety and Tolerability] [ Time Frame: 0 to 28 weeks ]
  • Incidence of respiratory AEs [Safety and Tolerability] [ Time Frame: 0 to 28 weeks ]
  • Incidence of respiratory SAEs [Safety and Tolerability] [ Time Frame: 0 to 28 weeks ]
  • Proportion of subjects discontinuing study drug due to AEs [Safety and Tolerability] [ Time Frame: 0 to 28 weeks ]
  • All cause mortality rate [Safety and Tolerability] [ Time Frame: 0 to 28 weeks ]
  • Mortality rate due to respiratory deterioration [Safety and Tolerability] [ Time Frame: 0 to 28 weeks ]
  • Incidence of disease related events associated with mortality [Safety and Tolerability] [ Time Frame: 0 to 28 weeks ]

    Description: Number of "respiratory decline" events over the 28 week study period as defined below:

    • Unscheduled visits to a healthcare professional for respiratory status deterioration.
    • Urgent care visit for respiratory status deterioration.
    • Hospitalization due to a worsening or exacerbation of respiratory symptoms.
    • Acute onset of symptoms (< 30 days in duration)
    • New radiographic abnormalities (bilateral ground glass or consolidation on HRCT with no pneumothorax or pleural effusion)
    • Absence of an identified infectious etiology by routine clinical practice
    • Exclusion of alternative causes by routine clinical practice, including:

      • Left heart failure
      • Pulmonary embolism
      • Identifiable cause of acute lung injury

  • Proportion (%) of subjects with a decline in FVC% predicted of ≥ 5% and ≥ 10% from Baseline to Week 28. [ Time Frame: 0 to 28 weeks ]
  • Proportion (%) of subjects with a decline in FVC of ≥ 100ml and ≥ 200ml from Baseline to Week 28. [ Time Frame: 0 to 28 weeks ]
  • Proportion of subjects with an increase in FVC % predicted of ≥ 5% and ≥10% from Baseline to Week 28. [ Time Frame: 0 to 28 weeks ]
  • Proportion of subjects with an increase in FVC of ≥ 100 ml and ≥ 200 ml from Baseline to Week 28 [ Time Frame: 0 to 28 weeks ]
  • Proportion of subjects with stable disease by FVC %, defined as a change in FVC % predicted of < 5% from Baseline to Week 28. [ Time Frame: 0 to 28 weeks ]
  • Proportion of subjects with stable disease by FVC in ml, defined as a change in FVC of < 100ml from Baseline to Week 28. [ Time Frame: 0 to 28 weeks ]
  • Mean change from Baseline to Week 28 in % predicted diffusion capacity of carbon monoxide (DLCO). [ Time Frame: 0 to 28 weeks ]
  • Change in 6-minute walk distance, in meters, from Baseline to Week 28. [ Time Frame: 0 to 28 weeks ]

Enrollment: 117
Study Start Date: August 2015
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRM-151 10mg / kg
Dosing Every 4 Weeks
Biological: PRM-151
PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks
Placebo Comparator: Placebo
Dosing Every 4 weeks
Other: placebo
Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Detailed Description:
PRM-151 is an anti-fibrotic immunomodulator being developed for treatment of fibrotic diseases.
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Is aged 40-80 years.
  2. Has IPF satisfying the American Thoracic Society/European Respiratory Society /Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu, Collard et al. 2011). In the absence of a surgical lung biopsy, HRCT must be "consistent with "usual interstitial pneumonia" (UIP) defined as meeting either criteria A, B, and C, or criteria A and C, or criteria B and C below:

    • Definite honeycomb lung destruction with basal and peripheral predominance.
    • Presence of reticular abnormality AND traction bronchiectasis consistent with fibrosis, with basal and peripheral predominance.
    • Atypical features are absent, specifically nodules and consolidation. Ground glass opacity, if present, is less extensive than reticular opacity pattern.
  3. If on pirfenidone or nintedanib, subject must have been on a stable dose of pirfenidone or nintedanib for at least 3 months without increase in FVC% predicted on two consecutive pulmonary function tests (PFTs), including screening PFTs. Subjects may not be on both pirfenidone and nintedanib.
  4. If not currently receiving pirfenidone or nintedanib, subject must have been off pirfenidone or nintedanib for ≥ 4 weeks before baseline.
  5. Has a FVC ≥ 50% and ≤ 90% of predicted.
  6. Has a DLCO ≥ 25% and ≤ 90% of predicted.
  7. Minimum distance on 6-Minute Walk Test (6MWT) of 150 meters.
  8. Has a forced expiratory volume in 1 second (FEV1)/FVC ratio > 0.70.
  9. Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ≤ 55 years or 12 months if > 55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception are defined in the protocol.
  10. Has a life expectancy of at least 9 months
  11. According to the investigator's best judgment, can comply with the requirements of the protocol.
  12. Has provided written informed consent to participate in the study.

Exclusion Criteria:

  1. Has emphysema ≥ 50% on HRCT or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
  2. Has a history of cigarette smoking within the previous 3 months.
  3. Has received investigational therapy for IPF within 4 weeks before baseline.
  4. Is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks of baseline.
  5. Received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline.
  6. Has a history of a malignancy within the previous 5 years, with the exception of basal cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring prior to 5 years must be considered cured, inactive, and not under current treatment.
  7. Has any concurrent condition other than IPF that, in the Investigator's opinion, is unstable and/or would impact the likelihood of survival for the study duration or the subject's ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study.
  8. Has baseline resting oxygen saturation of < 89% on room air or supplemental oxygen.
  9. Is unable to refrain from use of the following:

    • Short acting bronchodilators on the day of and within 12 hours of pulmonary function, DLCO, and 6 minute walk assessments.
    • Long acting bronchodilators on the day of and within 24 hours of these assessments.
  10. Has a known post bronchodilator (short acting beta agonist [SABA] - albuterol or salbutamol) increase in FEV1 of >10% and in FVC of >7.5%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02550873

Locations
United States, California
UCSF Interstitial Lung Disease Program
San Francisco, California, United States, 94143
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Texas
UT - Southwestern Medical School
Dallas, Texas, United States, 75930
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53715
Czech Republic
Thomayer Hospital
Prague, Czech Republic, 14059
Germany
Justus-Liebig University Giessen
Giessen, Germany, D-35392
Thoraxklinik University of Heidelberg
Heidelberg, Germany, D-69126
Italy
Az. Ospedaliera Universitaria-Policlinico V. Emanuele di Catania
Catania, Italy, 78-95123
Azienda Ospedaliera San Gerardo
Monza, Italy, 20900
Netherlands
Erasmus Medical Center
Rotterdam, Zuid Holland, Netherlands, 3015 CE
Spain
Hospital University de Bellvitge
Barcelona, Spain, 08907
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Promedior, Inc.
Investigators
Study Director: Bernt van den Blink, MD, PhD Promedior, Inc.
  More Information

Responsible Party: Promedior, Inc.
ClinicalTrials.gov Identifier: NCT02550873     History of Changes
Other Study ID Numbers: PRM-151-202
Study First Received: August 27, 2015
Last Updated: October 26, 2016

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on June 27, 2017