A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Treprostinil

Criteria

Inclusion Criteria:

• Males and females must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent form (ICF).

• Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonary fibrosis [IPF], connective tissue disease [CTD], sarcoidosis) at least 6 months prior to Screening.

• Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• Male participants:

Male participants who are not sterile, with female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.

Male participants with women of child bearing potential (WOCBP) partner must use a condom in order to avoid potential exposure to embryo/fetus.

• Female participants: Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie, post-tubal ligation for at least 12 months) or using highly effective contraception methods (ie, methods that alone or in combination achieve <1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose of study drug.

• Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

• Primary diagnosis of chronic obstructive pulmonary disease (COPD).

• Allergy, or documented hypersensitivity or contraindication to TPIP or treprostinil (TRE) or mannitol (an excipient of the TPIP formulation).

• Received or currently treated with riociguat, endothelial receptor antagonists, selexipag, phosphodiesterase 5 (PDE5) inhibitors and/or prostacyclin analogues within 30 days prior to Screening.

• Started therapy with pirfenidone or nintedanib < 90 days prior to Screening, OR, if already receiving either medication, there is a dose change within 30 days of Screening Visit

• Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmal atrial fibrillation), and/or any symptomatic bradycardia.

• History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).

• Participation in a cardiopulmonary rehabilitation program within 30 days of the first Screening Visit.

• Acutely decompensated heart failure within 30 days of Screening Visit.

• Active and current symptomatic COVID-19 and/or previous diagnosis of moderate to severe disease, or hospitalization due to COVID-19.

• Supplemental oxygen requirement > 10L/min at Screening.

• Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of the first dose of study drug (may be rescreened at appropriate time).

• Current or recent (past 30 days) lower respiratory tract infection (may be rescreened at appropriate time).

• Any form of congenital heart disease or congenital heart defect (repaired or unrepaired) other than a patent foramen ovale.

• History of alcohol or drug abuse within 6 months prior to Screening.

• Current use of cigarettes (as defined by Center for Disease Control (CDC)) or e-cigarettes

• Participants who currently inhale marijuana (recreational or medical).

• Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6-minute walk test (6MWT) (eg, angina pectoris, claudication, musculoskeletal disorder, need for walking aids).