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

NCT ID: NCT05176951

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-22
• Study Completion Date: 2024-03-14

Brief Summary

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

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Treprostinil Palmitil

Intervention Type: DRUG

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

Placebo

Participants will be administered a placebo matching TPIP once daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Treprostinil Palmitil

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

INS1009

Eligibility Criteria

Inclusion Criteria

• Males and females must be ≥ 18 to ≤ 80 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).
• 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,hysterectomy and/or bilateral salpingo-oophorectomy) 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, endothelin 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. Participation in the maintenance program of a cardiopulmonary rehabilitation program is allowed.
• Acutely decompensated heart failure within 30 days of Screening Visit.
• Active and current symptomatic coronavirus disease 2019 (COVID-19) and/or previous diagnosis of moderate to severe disease, or hospitalization due to COVID-19.
• Supplemental oxygen requirement > 10L/min at rest 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: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days.
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ARG003

Barracas, Ciudad Autónoma de BuenosAires, Argentina

ARG001

Rosario, Santa Fe Province, Argentina

ARG008

Buenos Aires, , Argentina

AUS003

Camperdown, New South Wales, Australia

AUS005

Macquarie Park, New South Wales, Australia

BEL002

Liège, , Belgium

GER006

Heidelberg, Baden-Wurttemberg, Germany

GER010

Giessen, Hesse, Germany

GER003

Essen, North Rhine-Westphalia, Germany

GER001

Dresden, Saxony, Germany

GER002

Berlin, , Germany

GER012

Berlin, , Germany

GER004

Munich, , Germany

ITA003

Napoli, Campania, Italy

ITA004

Milan, Lombardy, Italy

ITA002

Monza, Lombardy, Italy

ITA001

Palermo, Sicily, Italy

ESP003

Palma de Mallorca, Balearic Islands, Spain

ESP007

Oviedo, Principality of Asturias, Spain

ESP010

Barcelona, , Spain

ESP005

Barcelona, , Spain

ESP006

Las Palmas de Gran Canaria, , Spain

ESP009

Santiago de Compostela, , Spain

GBR003

Glasgow, Lanarkshire, United Kingdom

GBR001

Sheffield, Yorkshire, United Kingdom

Countries

Argentina; Australia; Belgium; Germany; Italy; Spain; United Kingdom

Other Identifiers

2021-003294-66

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INS1009-211

Identifier Type: -

Identifier Source: org_study_id