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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 10 July 2015
Main ID:  EUCTR2014-004782-24-NL
Date of registration: 08/12/2014
Prospective Registration: Yes
Primary sponsor: Promedior inc
Public title: A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.
Scientific title: A Pilot Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF).
Date of first enrolment: 06/05/2015
Target sample size: 60
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004782-24
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Netherlands
Contacts
Name: Judith Pool   
Address:  Hoofdstraat 15 7902 EA Hoogeveen Netherlands
Telephone: 31524712456
Email: judith.pool@vlsworldwide.com
Affiliation:  Venn Life Sciences
Name: Judith Pool   
Address:  Hoofdstraat 15 7902 EA Hoogeveen Netherlands
Telephone: 31524712456
Email: judith.pool@vlsworldwide.com
Affiliation:  Venn Life Sciences
Key inclusion & exclusion criteria
Inclusion criteria:
1.Subject is aged 40-80 years.
2.Subject has IPF satisfying the ATS/ERS/JRS/ALAT diagnostic criteria(Raghu, Collard et al. 2011). In the absence of a surgical lung biopsy, HRCT must be “consistent with UIP” defined as meeting either criteria A, B, and C, or criteria A and C, or criteria B and C below:
A.Definite honeycomb lung destruction with basal and peripheral predominance.
B.Presence of reticular abnormality AND traction bronchiectasis consistent with fibrosis, with basal and peripheral predominance.
C.Atypical features are absent, specifically nodules and consolidation. Ground glass opacity, if present, is less extensive than reticular opacity pattern.
3.If on pirfenidone, subject must have been on a stable dose of pirfenidone for at least 3 months without increase in FVC% predicted on two consecutive PFTs, including screening PFTs.
4.If not currently receiving pirfenidone, subject must have been off pirfenidone for = 4 weeks before baseline.
5.Subject has a FVC =50% and= 90% of predicted.
6.Subject has a DLCO =25% and = 90% of predicted.
7.Minimum distance on 6MWT of 150 meters.
8.Subject has a forced expiratory volume in 1 second (FEV1)/FVC ratio >0.70 post-bronchodilator.
9.Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if =55 years or 12 months if >55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence.
10.Subject has a life expectancy of at least 9 months
11.Subject, according to the investigator’s best judgment, can comply with the requirements of the protocol.
12.Subject has provided written informed consent to participate in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
1.Subject has emphysema =50% on HRCT or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
2.Subject has a history of cigarette smoking within the previous 3 months.
3.Subject has received investigational therapy for IPF within 4 weeks before baseline.
4.Subject has received nintedanib within the 4 weeks before baseline.
5.Subject is receiving systemic corticosteroids equivalent to prednisone> 10 mg/day or equivalent within 2 weeks of baseline.
6.Subject received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline.
7.Subject has a history of a malignancy within the previous 5 years, with the exception of basal cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring prior to 5 years must be considered cured, inactive, and not under current treatment.
8.Subject has any concurrent condition other than IPF that, in the Investigator’s opinion, is unstable and/or would impact the likelihood of survival for the study duration or the subject’s ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study.
9.Subject has baseline resting oxygen saturation of < 89% on room air or supplemental oxygen.
10.Subjects that are unable to refrain from use of the following:
a)Short acting bronchodilators on the day of and within 12 hours of pulmonary function, DLCO, and 6 minute walk assessments.
b)Long acting bronchodilators on the day of and within 24 hours of these assessments.
11.Subject has a known post bronchodilator (short acting beta agonist [SABA] – albuterol or salbutamol) increase in FEV1of >10% and in FVC of >7.5%.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Intervention(s)

Product Code: PRM-151
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: Demonstrate the superiority of PRM-151 to placebo in preservation or increase from baseline to 28 weeks in mean FVC% predicted in subjects on a stable dose of pirfenidone and subjects not on other treatment for IPF..
Primary end point(s): •The primary endpoint is the mean absolute change from baseline in FVC % predicted from baseline to week 28
Secondary Objective: •Demonstrate the superiority of PRM-151 to placebo in preservation or increase from baseline to 28 weeks in normal lung as quantified by structural imaging in subjects on a stable dose of pirfenidone and subjects not on other treatment for IPF.
•Assess the tolerability and safety of PRM-151 in subjects with IPF treated through24 weeks
•Assess the ability of PRM-151 to reduce disease-related events associated with mortality
•Assess the ability of PRM-151 to preserve or increase 6 minute walk distance
Timepoint(s) of evaluation of this end point: Week 28 of treatment
Secondary Outcome(s)
Secondary end point(s): 1Structural Imaging:
•Mean absolute change from baseline at 28 weeks in total lung volume and volume of parenchymal features (normal, ground glass density, reticular changes, honeycombing, and low attenuation areas) using quantitative imaging software to measure absolute volume (in ml) and relative % of total lung volume.
•Transitions between all categories of lung features (normal, ground glass density, reticular changes, honeycombing, and low attenuation areas) by quantitative imaging software.
2.Safety: Tolerability/safety will be assessed over the 24 week dosing period by the following parameters:
•Incidence of AEs.
•Incidence of serious adverse events (SAEs).
•Incidence of respiratory AEs and SAEs.
•Proportion of subjects discontinuing study drug due to AEs.
•Change from Baseline in hematology and serum chemistries.
•All cause mortality.
•Mortality due to respiratory deterioration.
3.Disease related events associated with mortality: The number of “respiratory decline” events over the 24 week dosing period as defined below:
•Unscheduled visits to a healthcare professional for respiratory status deterioration.
•Urgent care visit for respiratory status deterioration.
•Hospitalization due to a worsening or exacerbation of respiratory symptoms.
All “respiratory decline” events will be further characterized according to the definitions of IPF related disease exacerbation, as defined according to American Thoracic Society (ATS) criteria(Raghu, Collard et al. 2011):
•Unexplained worsening of dyspnea over 1 month.
•Worsened or severely impaired gas exchange.
•New radiographic alveolar infiltrates.
•The absence of another reason for the worsening respiratory symptoms, (pulmonary embolism, congestive heart failure, pneumothorax).
•Acute, unexplained decline in oxygen saturation over 1 month.
4.Pulmonary Function Tests
•Time weighted average (TWA) of change in FVC% predicted from Baseline to Week 28.
•TWA of change in FVC in ml from Baseline to Week 28.
•Proportion (%) of subjects with an absolute decline in FVC% predicted of =5% and =10%from Baseline to Week 28.
•Proportion (%) of subjects with an absolute decline in FVC of= 100ml and =200 ml from Baseline to Week 28.
•Proportion of subjects with an absolute increase in FVC % predicted of =5% and =10% from Baseline to Week 28.
•Proportion of subjects with an absolute increase in FVC in ml of =100ml and = 200ml from Baseline to Week 28.
•Mean absolute change from baseline in % predicted diffusion capacity of carbon monoxide (DLCO).
•Change in 6-minute walk distance, in meters, from baseline to Week 28.

Exploratory endpoints:
1.Patient Reported Outcomes
•Change in Patient Reported Outcomes as measured by King’s Brief Interstitial Lung Disease Questionnaire (K-BILD) and Leicester Cough Questionnaire (LCQ) from baseline to Week 28.
2.Quantitative Functional Respiratory Imaging
•Change from baseline to 28 weeks in regional lung volumes, specific airway volumes and resistance as measured by quantitative imaging software (FluidDA).
3.Biomarkers
•Changes in serum and cellular biomarkers and response according to baseline genetic characteristics: including but not limited toTLR3 L412F polymorphism, MUC5B promoter polymorphism.
Timepoint(s) of evaluation of this end point: With every visit after randomisation and at week 28
Secondary ID(s)
PRM-151-202
Source(s) of Monetary Support
Promedior Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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