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Completed

NCT Number: NCT01254409

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Human Drug Research, Leiden, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Placebo

Other

Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: PRM151F-12GL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 6, 2010
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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