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

NCT05176951 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: INS1009-2112021-003294-66
• Study Type: interventional
• Target: 39
• Locations: 7 countries
• Sites: 25

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

Keywords

Pulmonary Hypertension; Interstitial Lung Disease; Treprostinil Palmitil

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)

  Up to Day 140

• Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)

  Up to Day 140

• 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 Outcomes (16)

• Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil

  Day 1 to Week 16

• Cmax of Treprostinil

  Day 1 to Week 16

• Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil

  Day 1 to Week 16

• Tmax of Treprostinil

  Day 1 to Week 16

• Area Under Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUCtau) of Treprostinil Palmitil

  Day 1 to Week 16

Study Arms (2)

Treprostinil Palmitil

EXPERIMENTAL

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.

Drug: Treprostinil Palmitil

Placebo

PLACEBO COMPARATOR

Participants will be administered a placebo matching TPIP once daily.

Drug: Placebo

Interventions

Treprostinil Palmitil DRUG

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

Also known as: INS1009

Treprostinil Palmitil

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (25)

ARG003

Barracas, Ciudad Autónoma de BuenosAires, C1280AEB, Argentina

Location

ARG001

Rosario, Santa Fe Province, S2013KDS, Argentina

Location

ARG008

Buenos Aires, CI094AAD, Argentina

Location

AUS003

Camperdown, New South Wales, 2050, Australia

Location

AUS005

Macquarie Park, New South Wales, 2109, Australia

Location

BEL002

Liège, 4000, Belgium

Location

GER006

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

GER010

Giessen, Hesse, 35392, Germany

Location

GER003

Essen, North Rhine-Westphalia, 45239, Germany

Location

GER001

Dresden, Saxony, 01307, Germany

Location

GER002

Berlin, 13125, Germany

Location

GER012

Berlin, 14050, Germany

Location

GER004

Munich, 81377, Germany

Location

ITA003

Napoli, Campania, 80131, Italy

Location

ITA004

Milan, Lombardy, 20123, Italy

Location

ITA002

Monza, Lombardy, 20900, Italy

Location

ITA001

Palermo, Sicily, 90127, Italy

Location

ESP003

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

ESP007

Oviedo, Principality of Asturias, 33011, Spain

Location

ESP010

Barcelona, 08035, Spain

Location

ESP005

Barcelona, 08907, Spain

Location

ESP006

Las Palmas de Gran Canaria, 35010, Spain

Location

ESP009

Santiago de Compostela, 15706, Spain

Location

GBR003

Glasgow, Lanarkshire, G81 4HX, United Kingdom

Location

GBR001

Sheffield, Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 4, 2022
• Study Start: December 22, 2022
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); GB (2); DE (7); AU (2); AR (3); IT (4); ES (6)