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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05176951
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Insmed Incorporated
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension
Arms & Interventions

Arms

Experimental: Treprostinil Palmitil

Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.

Placebo Comparator: Placebo

Participants will be administered a placebo matching treprostinil palmitil (TPIP) once daily.

Interventions

Drug: - Treprostinil Palmitil

Oral inhalation using a capsule-based dry powder inhaler device

Drug: - Placebo

Oral inhalation using a capsule-based dry powder inhaler device.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

USA010, Altamonte Springs, Florida

Status

Recruiting

Address

USA010

Altamonte Springs, Florida, 32701-4817

USA002, Austell, Georgia

Status

Recruiting

Address

USA002

Austell, Georgia, 30106-1110

USA013, Indianapolis, Indiana

Status

Recruiting

Address

USA013

Indianapolis, Indiana, 46260-1992

USA003, Kansas City, Kansas

Status

Recruiting

Address

USA003

Kansas City, Kansas, 66160-8500

USA004, McKinney, Texas

Status

Recruiting

Address

USA004

McKinney, Texas, 75069-1898

International Sites

USA014, Guaynabo, Puerto Rico

Status

Recruiting

Address

USA014

Guaynabo, , 00926

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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