A study evaluating the efficacy and safety of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis
- Conditions
- Idiopathic Pulmonary FibrosisMedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-005881-17-DK
- Lead Sponsor
- ITED THERAPEUTICS CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 396
1. Subject gives voluntary informed consent to participate in the study.
2. Subject is =40 years of age, inclusive, at the time of signing informed consent.
3. The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and confirmed by central review of HRCT (performed within the previous 12 months) and if available, surgical lung biopsy. HRCT imaging 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. Subpleural and basal predominant honeycombing
b. Subpleural and basal predominant reticular pattern with peripheral traction bronchiectasis or traction bronchiolectasis
c. Absence of atypical features (eg, predominant ground-glass opacity, nodules, consolidation, etc). If ground-glass opacity is present, it must be less than the accompanying reticular pattern.
Subjects with HRCT features deemed indeterminate for IPF (subpleural and basal predominant, subtle, reticulating pattern of fibrosis) may be considered for inclusion if coupled with a histopathological pattern of UIP” or probable UIP” on surgical lung biopsy and confirmed by central review.
4. FVC =45% predicted at Screening.
5. Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for =30 days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not permitted.
6. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will do 1 of the following:
a. Abstain from intercourse (when it is in line with their preferred and usual lifestyle)
b. Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
1. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide.
Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as
amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential.
7. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
8. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
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 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 547
1. Subject is pregnant or lactating
2. Subject has primary obstructive airway physiology: FEV1/FVC <0.70 at Screening.
3. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
4. The subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), or soluble guanylate cyclase stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours of any study-related efficacy assessments.
5. Use of any of the following medications:
a. Azathioprine (AZA), cyclosporine, mycophenolate mofetil, tacrolimus, oral corticosteroids (OCS) >20 mg/day or the combination of
OCS+AZA+N-acetylcysteine within 30 days prior to Baseline.
b. Cyclophosphamide within 60 days prior to Baseline
c. Rituximab within 6 months prior to Baseline
6. The subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
7. Exacerbation of IPF or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of IPF or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to
Baseline to be eligible.
8. Uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
9. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation.
10. Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible.
11. Life expectancy <6 months due to IPF or a concomitant illness.
12. Acute pulmonary embolism within 90 days prior to Baseline
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of RIN-PF-303 is to evaluate the superiority of inhaled treprostinil against placebo for annual rate of change in absolute forced vital capacity (FVC) from baseline to Week 52;Secondary Objective: Not Applicable;Primary end point(s): The primary endpoint of the study is the annual rate of change in absolute FVC in subjects with IPF from baseline to Week 52.;Timepoint(s) of evaluation of this end point: From baseline to Week 52.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary efficacy endpoints of the study are:<br>• Time to clinical worsening (including time to death, respiratory hospitalization, or =10% relative decline in % predicted FVC)<br>• Time to first acute exacerbation of IPF<br>• Overall survival at Week 52<br>• Change from baseline in % predicted FVC at Week 52<br>• Change from baseline in King’s Brief Interstitial Lung Disease Questionnaire score at Week 52<br>• Change from baseline in diffusion capacity of lungs for carbon monoxide at Week 52;Timepoint(s) of evaluation of this end point: From baseline to Week 52.