Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PRM151F-12GL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01254409
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : November 2, 2014
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Promedior, Inc.

Tracking Information
First Submitted Date  ICMJE December 3, 2010
First Posted Date  ICMJE December 6, 2010
Results First Submitted Date  ICMJE April 11, 2014
Results First Posted Date  ICMJE November 2, 2014
Last Update Posted Date October 9, 2018
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
Safety and Tolerability [ Time Frame: From first dose on Day 1 through Day 57 ]
Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2014)
  • Cmax [ Time Frame: Day 15 ]
    Maximum concentration
  • Tmax [ Time Frame: Day 15 ]
    Time of Maximum observed concentration
  • AUC48 [ Time Frame: Day 15 ]
    Area under the curve from 0 to 48 hrs post dose, with samples collected at 0.5, 0.75, 1, 1.5, 2, 3,4,6,8,12,16, 24 and 48 hours post Day 15 dose.
  • Terminal Elimination Half Life [ Time Frame: Day 15 ]
  • Total Body Clearance [ Time Frame: Day 15 ]
  • Vss [ Time Frame: Day 15 ]
    Volume of Distribution at Steady State
  • FVC (Forced Vital Capacity) Change From Baseline to Day 57 [ Time Frame: Change from Day 1 (Baseline) to Day 57 ]
  • FVC (Forced Vital Capacity) % Predicted Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ]
  • DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ]
  • FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ]
  • 6MWT (6 Minute Walk Test) Distance Walked Change From Baseline [ Time Frame: Screening (between Day -35 and Day 1) and Day 57 ]
    Change from baseline (measured during screening period) in distance walked during a 6 minute walk test
  • SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ]
    St. George's Respiratory Questionnaire Total Score. Scores range from 0 (no impairment) to 100 (maximum impairment). A decrease in score represents a decrease in disease related symptoms. The SGRQ is not validated for IPF.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official Title  ICMJE A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients With Idiopathic Pulmonary Fibrosis
Brief Summary The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
Detailed Description

Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease with a histological picture of usual interstitial pneumonia and a deteriorating clinical course. The prognosis is poor. Chronic alveolar inflammation with associated parenchymal remodeling is theorized to promote an ongoing abnormal fibrogenic repair response. Corticosteroids and immunomodulatory agents have not been shown to benefit IPF patients. Recently several published clinical studies have indicated a strong correlation between IPF severity and/or disease progression and the levels of specific plasma biomarker proteins related to epithelial cell health and extracellular matrix turnover.

PRM-151 is being developed for potential therapeutic uses to prevent, treat, and reduce fibrosis.

This study is the first intravenous multiple-dose study in humans, and will be conducted in patients with IPF. Patients will be randomized to receive either PRM-151 or placebo.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Biological: PRM-151
    Intravenous PRM-151 administered over 30 minutes on study days 1, 3, 5, 8, and 15 at doses of 1.0, 5.0, or 10.0 mg/kg.
  • Other: Placebo
    Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.
Study Arms  ICMJE
  • Experimental: PRM-151
    PRM-151 administered at escalating doses of 1, 5, and 10 mg/kg by 30 minute intravenous (IV) infusion days 1, 3, 5, 8 and 15.
    Intervention: Biological: PRM-151
  • Placebo Comparator: Placebo
    0.9% saline administered by 30 minute IV infusion Days 1, 3, 5, 8, and 15.
    Intervention: Other: Placebo
Publications * van den Blink B, Dillingh MR, Ginns LC, Morrison LD, Moerland M, Wijsenbeek M, Trehu EG, Bartholmai BJ, Burggraaf J. Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy. Eur Respir J. 2016 Mar;47(3):889-97. doi: 10.1183/13993003.00850-2015. Epub 2016 Feb 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2010)
21
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women of non-childbearing potential aged 40 to 80 years at screening.
  • Diagnosis of idiopathic pulmonary fibrosis (IPF) as determined by high resolution computerized tomography (HRCT) and pulmonary function tests.

Exclusion Criteria:

  • History or presence of connective tissue disorder, tuberculosis (TB), cystic fibrosis, sarcoidosis, amyloidosis or other pulmonary disease except idiopathic pulmonary fibrosis (IPF).
  • History or presence of chronic pulmonary obstructive disease, severe pulmonary hypertension, drug-induced pulmonary toxicity, other forms of idiopathic pneumonia, or interstitial lung diseases associated with environmental exposure medication or systemic disease.
  • High resolution computerized tomography (HRCT) findings inconsistent with idiopathic pulmonary fibrosis(IPF).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01254409
Other Study ID Numbers  ICMJE PRM151F-12GL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Promedior, Inc.
Study Sponsor  ICMJE Promedior, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Getsy, DMD, DO Promedior, Inc.
PRS Account Promedior, Inc.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP