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| ID | Type | Description | Link |
|---|---|---|---|
| PRM151F-12GL | Other Identifier | Promedior, Inc. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRM-151 | Experimental | 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. |
|
| Placebo | Placebo Comparator | 0.9% saline administered by 30 minute IV infusion Days 1, 3, 5, 8, and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRM-151 | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events | From first dose on Day 1 through Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration | Day 15 |
| Tmax | Time of Maximum observed concentration | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Getsy, DMD, DO | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Duke Clinical Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26869678 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
| FG001 | PRM-151 1 mg/kg | PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
| FG002 | PRM-151 5 mg/kg | PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
| FG003 | PRM-151 10 mg/kg | PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects enrolled in study
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
| BG001 | PRM-151 1 mg/kg | PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability | Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events | All subjects who received at least one dose of study treatment | Posted | Number | participants | From first dose on Day 1 through Day 57 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bernt van den Blink | Promedior, Inc. | 781-538-4203 | bvandenblink@promedior.com |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| C552898 | PRM-151 |
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| Placebo | Other | Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15. |
|
| AUC48 | 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. | Day 15 |
| Terminal Elimination Half Life | Day 15 |
| Total Body Clearance | Day 15 |
| Vss | Volume of Distribution at Steady State | Day 15 |
| FVC (Forced Vital Capacity) Change From Baseline to Day 57 | Change from Day 1 (Baseline) to Day 57 |
| FVC (Forced Vital Capacity) % Predicted Change From Baseline | Day 1 (Baseline) and Day 57 |
| DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline | Day 1 (Baseline) and Day 57 |
| FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline | Day 1 (Baseline) and Day 57 |
| 6MWT (6 Minute Walk Test) Distance Walked Change From Baseline | Change from baseline (measured during screening period) in distance walked during a 6 minute walk test | Screening (between Day -35 and Day 1) and Day 57 |
| SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline | 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. | Day 1 (Baseline) and Day 57 |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Center for Human Drug Research | Leiden | Netherlands |
| BG002 | PRM-151 5 mg/kg | PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
| BG003 | PRM-151 10 mg/kg | PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FVC | Forced Vital Capacity: volume of air that can forcibly be blown out after full inspiration, measured in liters | Mean | Standard Deviation | liters |
|
| FVC % Predicted | The % of the FVC that would be predicted for a subject based on physical characteristics that influence the maximal inhalation: height, age, and gender. | Mean | Standard Deviation | percent |
|
| FEV1 % Predicted | Forced Expiratory Volume 1 second: the volume of air expired in the first second during maximal expiratory effort. FEV1% predicted is the FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex and body composition | Mean | Standard Deviation | percent |
|
| DLCO | Diffusing capacity carbon monoxide is the carbon monoxide uptake from a single inspiration in a standard time (usually 10 seconds). DLCO% predicted is the % of the DLCO that would be predicted based on the subject's hemoglobin. | Mean | Standard Deviation | percent |
|
| PRM-151 5 mg/kg |
PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
| OG003 | PRM-151 10 mg/kg | PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 |
|
|
| Secondary | Cmax | Maximum concentration | Subjects who received all doses of study treatment | Posted | Mean | Standard Deviation | µg/mL | Day 15 |
|
|
|
| Secondary | Tmax | Time of Maximum observed concentration | Posted | Mean | Standard Deviation | hours | Day 15 |
|
|
|
| Secondary | AUC48 | 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. | Posted | Mean | Standard Deviation | µg*hr/mL | Day 15 |
|
|
|
| Secondary | Terminal Elimination Half Life | Posted | Mean | Full Range | hour | Day 15 |
|
|
|
| Secondary | Total Body Clearance | Posted | Mean | Full Range | ml/hr/kg | Day 15 |
|
|
|
| Secondary | Vss | Volume of Distribution at Steady State | Posted | Mean | Full Range | mL/kg | Day 15 |
|
|
|
| Secondary | FVC (Forced Vital Capacity) Change From Baseline to Day 57 | Posted | Mean | Standard Deviation | liters | Change from Day 1 (Baseline) to Day 57 |
|
|
|
| Secondary | FVC (Forced Vital Capacity) % Predicted Change From Baseline | Posted | Mean | Standard Deviation | absolute change in % predicted FVC | Day 1 (Baseline) and Day 57 |
|
|
|
| Secondary | DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline | Posted | Mean | Standard Deviation | Absolute change in % predicted DLCO | Day 1 (Baseline) and Day 57 |
|
|
|
| Secondary | FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline | Posted | Mean | Standard Deviation | Absolute change in FEV1 % predicted | Day 1 (Baseline) and Day 57 |
|
|
|
| Secondary | 6MWT (6 Minute Walk Test) Distance Walked Change From Baseline | Change from baseline (measured during screening period) in distance walked during a 6 minute walk test | Posted | Mean | Standard Deviation | meters | Screening (between Day -35 and Day 1) and Day 57 |
|
|
|
| Secondary | SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 (Baseline) and Day 57 |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | PRM-151 1 mg/kg | PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 | 0 | 6 | 6 | 6 |
| EG002 | PRM-151 5 mg/kg | PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 | 0 | 5 | 5 | 5 |
| EG003 | PRM-151 10 mg/kg | PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15 | 0 | 4 | 4 | 4 |
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hematoma | General disorders | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| Catheter site hematoma | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Investigators agree that the first public presentation of data will be a joint, multicentre publication of results. If this does not occur within 12 months after conclusion of the study, investigator may publish the results, provided that the complete manuscript or other publication is submitted to the sponsor for review 30 days prior to submission.
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |