臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 31, 2025
Last modified on	Mar. 31, 2025
Trial ID	jRCT2051240306

Scientific Title	A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease
Public Title	A Study of Mosliciguat in PH-ILD (PHocus) (Phocus)

Contact for Scientific Queries	Name	Martin Ubaldo
	Affiliation	Pulmovant, Inc.
	Address	303 Wyman St, Suite 300 Waltham, Massachusetts, 02451 USA
	Telephone	19194621310
	E-mail	clinicaltrials@pulmovant.com
Contact for Public Queries	Name	Clinical trial contact
	Affiliation	ICON Clinical Research GK
	Address	Kyutaromachi 4-chome 1-3, Chuo-ku, Osaka city, Osaka 541-0056, Japan
	Telephone	+81-6-4560-2001
	E-mail	ICONCR-Chiken@iconplc.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 04, 2025
Actual date of first enrollment
Target sample size		12
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Participants willing and able to provide informed consent. 2. Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed diseases include: a.Idiopathic interstitial pneumonia (IIP). b.Chronic hypersensitivity pneumonitis. c.ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) -<70% of predicted. 3. Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC). 4. Ability to perform 6MWD >= 100 meters. Note: Other inclusion criteria may apply.
	Exclusion Criteria	1. Diagnosis of PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified). 2. Exacerbation of underlying lung disease within 28 days prior to randomization. 3. Initiation of pulmonary rehabilitation within 28 days prior to randomization. 4. Receiving ->10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline. 5. History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators. 6. Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization. Note: Other exclusion criteria may apply.
	Age Minimum	18age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pulmonary Hypertension Associated with Interstitial Lung Disease
Intervention(s)		Investigational medical product: mosliciguat 1, 2 and 4mg Administration route: inhalation Part 1:All participants will be assessed for pre-dose 6MWD on Day 1 (6MWD baseline) and will initiate treatment at 1 mg or matched placebo once daily (QD) administered as inhaled dry powder. Uptitration will proceed over the protocol defined period up to the maximum delivered dose of 4 mg or matched placebo QD. Part 2: After Part 1 Week 24 assessments are complete, all participants will return to the clinic the next day to receive the first dose in the Extension period. Those initially randomized to mosliciguat will continue mosliciguat, and those initially randomized to placebo will start a mosliciguat uptitration[over the protocol defined period]. Reference product: placebo Administration route: inhalation
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Percent change from baseline in PVR assessed at estimated peak exposure at Week 16 by right heart catheterization (RHC)
Secondary Outcome(s)		1.Change in 6MWD from baseline measured at estimated peak exposure at Week 16 using the 6-Minute Walk Test (6MWT) 2.Change from baseline in NT-proBNP at Week 16

Primary Sponsor	Pulmovant, Inc.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Cerebral and Cardiovascular Center Institutional Review Board
Address	6-1 Kishibe-Shimmachi, Suita, Osaka
Telephone	+81-570-012-545
E-Mail
Approval Status	Approval
Date of approval	Jan. 21, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)	2024-513991-16-00
Issuing Authority

Countries of Recruitment（Except Japan）	Argentina/Australia/Belgium/Brazil/Canada/France/Germany/Italy/Mexico/Netherlands/New Zealand/South Korea/Spain/Turkey/United Kingdom/United States/Latvia/Czech Republic/Poland