Overview

Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
0
Participant gender:
All
Summary
Study RIN-PF-301 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) over a 52-week period.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
United Therapeutics
Treatments:
Treprostinil
Criteria
Inclusion Criteria:

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 high-resolution
computed tomography (HRCT) (performed within the previous 12 months), and if
available, surgical lung biopsy.

4. FVC ≥45% and ≤80% 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 abstain from
intercourse (when it is in line with their preferred and usual lifestyle) or use 2
medically acceptable, highly effective forms of contraception for the duration of the
study, and at least 30 days after discontinuing study drug.

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.

Exclusion Criteria:

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: 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;
cyclophosphamide within 60 days prior to Baseline; or 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 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.