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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    32
  • sponsor
    Insmed Incorporated
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Updated on 17 June 2022
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sarcoidosis
treprostinil

Summary

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

Details
Condition Pulmonary Hypertension
Treatment Placebo, Treprostinil Palmitil
Clinical Study IdentifierNCT05176951
SponsorInsmed Incorporated
Last Modified on17 June 2022

Eligibility

 Yes No Not Sure

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
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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