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
Conditions
Interventions
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
Sponsors
Promedior inc
Eligibility
Sex/Gender
All
Inclusion 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
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 10% and in FVC of >7.5%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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;Timepoint(s) of evaluation of this end point: Week 28 of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Contacts
Public ContactJudith Pool
Venn Life Sciences
Outcome results
None listed