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

Pulmonary Hypertension Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05176951
• Other study ID #: INS1009-211
• Secondary ID: 2021-003294-66
• Status: Completed
• Phase: Phase 2
• Start date: December 22, 2022
• Est. completion date: March 14, 2024

Study information

• Verified date: March 2024
• Source: Insmed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Hypertension

Intervention

Drug:
• Treprostinil Palmitil
Oral inhalation using a capsule-based dry powder inhaler device.
• Placebo
Oral inhalation using a capsule-based dry powder inhaler device.

Locations

Country	Name	City	State
Argentina	ARG003	Barracas	Ciudad Autónoma De BuenosAires
Argentina	ARG008	Buenos Aires
Argentina	ARG001	Rosario	Santa Fe
Australia	AUS003	Camperdown	New South Wales
Australia	AUS005	Macquarie Park	New South Wales
Belgium	BEL002	Liège
Germany	GER002	Berlin
Germany	GER012	Berlin
Germany	GER001	Dresden	Sachsen
Germany	GER003	Essen	Nordrhein-Westfalen
Germany	GER010	Gießen	Hessen
Germany	GER006	Heidelberg	Baden-Württemberg
Germany	GER004	Munich
Italy	ITA004	Milano	Lombardia
Italy	ITA002	Monza	Lombardia
Italy	ITA003	Napoli	Campania
Italy	ITA001	Palermo	Sicilia
Spain	ESP005	Barcelona
Spain	ESP010	Barcelona
Spain	ESP006	las Palmas de Gran Canaria
Spain	ESP007	Oviedo	Asturias
Spain	ESP003	Palma de Mallorca	Baleares
Spain	ESP009	Santiago de Compostela
United Kingdom	GBR003	Glasgow	Lanarkshire
United Kingdom	GBR001	Sheffield	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)		Up to Day 140
Primary	Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)		Up to Day 140
Primary	Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels		Pre-, during, and post- 6-minute walk test (6MWT) at Baseline, Week 5, Week 10, and Week 16
Secondary	Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil		Day 1 to Week 16
Secondary	Cmax of Treprostinil		Day 1 to Week 16
Secondary	Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil		Day 1 to Week 16
Secondary	Tmax of Treprostinil		Day 1 to Week 16
Secondary	Area Under Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUCtau) of Treprostinil Palmitil		Day 1 to Week 16
Secondary	AUCtau of Treprostinil		Day 1 to Week 16
Secondary	Area Under Concentration-time Curve From 0 to Infinity (AUC8) of Treprostinil Palmitil		Day 1 to Week 16
Secondary	AUC8 of Treprostinil		Day 1 to Week 16
Secondary	Area Under Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil		Day 1 to Week 16
Secondary	AUClast of Treprostinil		Day 1 to Week 16
Secondary	Apparent Total Clearance (CL/F) of Treprostinil Palmitil		Day 1 to Week 16
Secondary	CL/F of Treprostinil		Day 1 to Week 16
Secondary	Elimination Half-life (t1/2) of Treprostinil Palmitil		Day 1 to Week 16
Secondary	t1/2 of Treprostinil		Day 1 to Week 16
Secondary	Apparent Volume of Distribution After Terminal Phase (Vd/F) of Treprostinil Palmitil		Day 1 to Week 16
Secondary	Vd/F of Treprostinil		Day 1 to Week 16