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

Idiopathic Pulmonary Fibrosis Clinical Trial

— PRM151F-12GL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254409
• Other study ID #: WA42403
• Secondary ID: PRM151F-12GL
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2011
• Est. completion date: July 2, 2012

Study information

• Verified date: March 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2, 2012
• Est. primary completion date: July 2, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Center for Human Drug Research	Leiden
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke Clinical Research Unit	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Cmax	Maximum concentration	Day 15
Secondary	Tmax	Time of Maximum observed concentration	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.	Day 15
Secondary	Terminal Elimination Half Life		Day 15
Secondary	Total Body Clearance		Day 15
Secondary	Vss	Volume of Distribution at Steady State	Day 15
Secondary	FVC (Forced Vital Capacity) Change From Baseline to Day 57		Change from Day 1 (Baseline) to Day 57
Secondary	FVC (Forced Vital Capacity) % Predicted Change From Baseline		Day 1 (Baseline) and Day 57
Secondary	DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline		Day 1 (Baseline) and Day 57
Secondary	FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline		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	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.	Day 1 (Baseline) and Day 57