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RECRUITING
NCT07179380
PHASE3

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Sponsor: Insmed Incorporated

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

344

Start Date

2026-01-07

Completion Date

2028-12-30

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Treprostinil Palmitil Inhalation Powder

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

DRUG

Placebo

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

Locations (49)

USA001

Santa Barbara, California, United States

USA006

Naples, Florida, United States

USA003

Bend, Oregon, United States

USA008

Richmond, Virginia, United States

ARG003

Río Cuarto, Córdoba Province, Argentina

ARG008

San Miguel de Tucumán, Tucumán Province, Argentina

BEL002

Leuven, Belgium

CZE001

Prague, Czechia

FRA003

Le Kremlin-Bicêtre, France

GEO002

Tbilisi, Georgia

GEO004

Tbilisi, Georgia

GEO003

Tbilisi, Georgia

GEO001

Tbilisi, Georgia

DEU012

Stuttgart, Baden-Wurttemberg, Germany

DEU003

München, Bavaria, Germany

DEU006

München, Bavaria, Germany

DEU005

Immenhausen, Hesse, Germany

DEU008

Bonn, North Rhine-Westphalia, Germany

DEU010

Gauting, Germany

ISR003

Petah Tikva, Central District, Israel

ISR001

Haifa, Israel

ISR002

Jerusalem, Israel

ISR004

Tel Aviv, Israel

ITA012

Sassari, Italy

JPN006

Nagakute, Aichi-ken, Japan

JPN002

Narashino-shi, Chiba, Japan

JPN004

Narita, Chiba, Japan

JPN001

Sapporo, Hokkaido, Japan

JPN007

Yokohama, Kanagawa, Japan

JPN013

Bunkyo-Ku, Tokyo, Japan

JPN008

Kiyose, Tokyo, Japan

JPN003

Shibuya City, Tokyo, Japan

JPN005

Nagano, Japan

NZL001

Christchurch, Canterbury, New Zealand

NZL002

Dunedin, Otago, New Zealand

PRT001

Lisbon, Portugal

KOR001

Seoul, South Korea

KOR006

Seoul, South Korea

KOR005

Wŏnju, South Korea

ESP010

Majadahonda, Madrid, Spain

ESP012

Barcelona, Spain

ESP004

Barcelona, Spain

ESP006

Madrid, Spain

ESP009

Madrid, Spain

ESP003

Madrid, Spain

ESP002

Palma de Mallorca, Spain

ESP011

Santiago de Compostela, Spain

ESP001

Seville, Spain

TWN001

Kaohsiung City, Taiwan