A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    99
  • sponsor
    Insmed Incorporated
Updated on 7 June 2022

Summary

The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance.

Details
Condition Pulmonary Arterial Hypertension
Treatment Placebo, Treprostinil Palmitil
Clinical Study IdentifierNCT05147805
SponsorInsmed Incorporated
Last Modified on7 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must be ≥ 18 to ≤ 75 years at the time of signing the informed consent form (ICF). Participants in Japan must be ≥ 20 years of age at the time of signing the ICF
Participants must have a diagnosis of World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) (PAH) in any of the following subtypes
Idiopathic
Heritable
Drug/toxin-induced or connective tissue disease (CTD)-associated PAH
PAH diagnosis for at least 1 year
Participants must be on stable PH therapy consisting of up to 2 medications from the following classes
Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan)
Phosphoesterase type 5 inhibitors (eg, sildenafil, tadalafil)
Guanylate cyclase stimulator (eg, riociguat)
No change in PH medications (eg, ambrisentan, bosentan, macitentan, sildenafil
tadalafil, riociguat) or dosage for at least 60 days prior to Screening
No change in diuretic use or dosage for at least 30 days prior to Screening
Body Mass Index (BMI) within the range 19.0-32.0 kg/m^2 (inclusive)
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
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
Male participants with pregnant or non-pregnant woman of childbearing potential partner must use a condom in order to avoid potential exposure to embryo/fetus
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol

Exclusion Criteria

History of PH other than idiopathic, hereditary, drug/toxin-induced, or CTD-associated PAH (eg, congenital heart disease-associated PAH, portal hypertension-associated PAH, PH belonging to Groups 2 through 5)
Allergy, or documented hypersensitivity or contraindication, to TPIP or Treprostinil or mannitol (an excipient of the TPIP formulation)
Any known ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and 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 cardio-pulmonary rehabilitation program within 1 month of Screening Visit
Evidence of thromboembolic disease as assessed by ventilation-perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan
Active liver disease or hepatic dysfunction
History of HIV infection
Established diagnosis of hepatitis B viral infection, or positive for hepatitis B surface antigen (HBsAg) at the time of Screening
Established diagnosis of hepatitis C viral infection at the time of screening
Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19
Use of live attenuated vaccines within 4 weeks of the Screening Visit
Participants with Down's Syndrome
History of abnormal bleeding or bruising
History of solid organ transplantation
Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune compromised status, as judged by the Investigator
History of alcohol or drug abuse within 6 months prior to Screening
Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6-minute walk test (eg, angina pectoris, claudication, musculoskeletal disorder, need for walking aids)
Participants with current or recent (past 4 weeks) lower respiratory tract infection
History of malignancy in the past 5 years, with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin
Change in PH medication (endothelin receptor agonists, phosphoesterase type 5 inhibitors, and guanylate cyclase stimulators or diuretics) between Screening and Baseline
Have participated in any other interventional clinical studies within 30 days of Baseline
Current use of cigarettes (as defined by Centers for Disease Control and Prevention) or e-cigarettes
Participants who currently inhale marijuana (recreational or medical)
Pregnant or breastfeeding
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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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