A Randomized, Double-blind, Placebo-controlled, study of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis

Phase 3

Recruiting

Conditions: J841 Other interstitial pulmonary diseases with fibrosis
Other interstitial pulmonary diseases with fibrosis
J841

Registration Number: PER-052-22

Lead Sponsor: ITED THERAPEUTICS CORPORATIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: In enrollment

Sex: All

Target Recruitment: 13

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 (the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association) Clinical Practice Guideline and confirmed by central review of HRCT (High-resolution computed tomography; performed within the previous 12 months) and if available, surgical lung biopsy.
4.FVC (Forced vital capacity) =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 measures established in the protocol.
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: (Forced expiratory volume in 1 second/ Forced vital capacity) 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 Pulmonary arterial hypertension-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 Idiopathic pulmonary fibrosis 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, edication/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 Idiopathic pulmonary fibrosis or a concomitant illness.
12.Acute pulmonary embolism within 90 days prior to Baseline.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spirometry<br> NAME OF THE RESULT: Change in absolute<br>forced vital capacity (FVC)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: From baseline to Week 52.

Secondary Outcome Measures