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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 : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Biological: PRM-151 Other: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 29, 2011
Actual Primary Completion Date : July 2, 2012
Actual Study Completion Date : July 2, 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
Placebo Comparator: Placebo
0.9% saline administered by 30 minute IV infusion Days 1, 3, 5, 8, and 15.
 Other: Placebo
Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Day 15 ]
    Maximum concentration

  2. Tmax [ Time Frame: Day 15 ]
    Time of Maximum observed concentration

  3. 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.

  4. Terminal Elimination Half Life [ Time Frame: Day 15 ]
  5. Total Body Clearance [ Time Frame: Day 15 ]
  6. Vss [ Time Frame: Day 15 ]
    Volume of Distribution at Steady State

  7. FVC (Forced Vital Capacity) Change From Baseline to Day 57 [ Time Frame: Change from Day 1 (Baseline) to Day 57 ]
  8. FVC (Forced Vital Capacity) % Predicted Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ]
  9. DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ]
  10. FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ]
  11. 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

  12. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254409


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
Netherlands
Center for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: John Getsy, DMD, DO Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01254409    
Other Study ID Numbers: WA42403
PRM151F-12GL ( Other Identifier: Promedior, Inc. )
First Posted: December 6, 2010    Key Record Dates
Results First Posted: November 2, 2014
Last Update Posted: April 20, 2022
Last Verified: March 2022
Keywords provided by Hoffmann-La Roche:
pulmonary, fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases