A Study of Mosliciguat in PH-ILD (PHocus)

September 9, 2026 updated by: Pulmovant, Inc.

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

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, double-blind, placebo-controlled study with an extension.

The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks).

Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period.

All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Santa Fe, Argentina, S3000EOZ
        • Clinical Research Site
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1426
        • Clinical Research Site
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Clinical Research Site
      • Westmead, New South Wales, Australia, 2145
        • Clinical Research Site
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Clinical Research Site
  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1070
        • Clinical Research Site
    • Flanders
      • Leuven, Flanders, Belgium, 3000
        • Clinical Research Site
  • Brazil
      • São Paulo, Brazil, 04024-002
        • Clinical Research Site
      • São Paulo, Brazil, 05403-904
        • Clinical Research Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020090
        • Clinical Research Site
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-906
        • Clinical Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Clinical Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Clinical Research Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Clinical Research Site
  • Czechia
    • Prague
      • Prague, Prague, Czechia, 128 08
        • Clinical Research Site
      • Prague, Prague, Czechia, 140 59
        • Clinical Research Site
  • France
    • Auvergne-Rhône-Alpes
      • Bron, Auvergne-Rhône-Alpes, France, 69677
        • Clinical Research Site
      • Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France, 42270
        • Clinical Research Site
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67091
        • Clinical Research Site
    • Île-de-France Region
      • Le Kremlin-Bicêtre, Île-de-France Region, France, 94270
        • Clinical Research Site
  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Clinical Research Site
    • Bavaria
      • München, Bavaria, Germany, 81377
        • Clinical Research Site
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Clinical Research Site
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Clinical Research Site
  • Italy
      • Naples, Italy, 80131
        • Clinical Research Site
      • Palermo, Italy, 90127
        • Clinical Research Site
      • Roma, Italy, 00161
        • Clinical Research Site
    • Genoa
      • Genova, Genoa, Italy, 16132
        • Clinical Research Site
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Clinical Research Site
  • Japan
    • Chiba
      • Narashino, Chiba, Japan, 2758580
        • Clinical Research Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Clinical Research Site
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Clinical Research Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Clinical Research Site
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 701-1192
        • Clinical Research Site
    • Osaka
      • Suita, Osaka, Japan, 564-8565
        • Clinical Research Site
    • Tokyo
      • Chiyoda City, Tokyo, Japan, 102-0071
        • Clinical Research Site
  • Latvia
      • Riga, Latvia, 1002
        • Clinical Research Site
  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • Clinical Research Site
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Clinical Research Site
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • Clinical Research Site
  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8041
        • Clinical Research Site
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3240
        • Clinical Research Site
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61 848
        • Clinical Research Site
    • Lódzkie
      • Lodz, Lódzkie, Poland, 91-347
        • Clinical Research Site
    • Masovian Voivodeship
      • Otwock, Masovian Voivodeship, Poland, 05-400
        • Clinical Research Site
  • South Korea
    • Incheon Gwang'yeogsi [Inch'on-Kwangyokshi]
      • Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], South Korea, 21565
        • Clinical Research Site
    • Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
      • Dongjak, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 7061
        • Clinical Research Site
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 06351
        • Clinical Research Site
    • Seoul-Teukbyeolsi
      • Seoul, Seoul-Teukbyeolsi, South Korea, 05505
        • Clinical Research Site
  • Spain
      • Madrid, Spain, 28041
        • Clinical Research Site
      • Toledo, Spain, 45007
        • Clinical Research Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Clinical Research Site
    • Málaga
      • Marbella, Málaga, Spain, 29603
        • Clinical Research Site
  • Turkey (Türkiye)
    • Istanbul
      • Pendik, Istanbul, Turkey (Türkiye), 34899
        • Clinical Research Site
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Clinical Research Site
  • United Kingdom
    • England
      • Cambridge, England, United Kingdom, CB2 0AY
        • Clinical Research Site
      • London, England, United Kingdom, NW3 2QG
        • Clinical Research Site
      • London, England, United Kingdom, SW3 6NP
        • Clinical Research Site
      • London, England, United Kingdom, W12 0HS
        • Clinical Research Site
    • Scotland
      • Clydebank, Scotland, United Kingdom, G81 4DY
        • Clinical Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Clinical Research Site
    • California
      • Los Angeles, California, United States, 90024
        • Clinical Research Site
      • Sacramento, California, United States, 95817
        • Clinical Research Site
      • Santa Barbara, California, United States, 93105
        • Clinical Research Site
      • Torrance, California, United States, 90502
        • Clinical Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Clinical Research Site
    • Florida
      • Celebration, Florida, United States, 34746
        • Clinical Research Site
    • Illinois
      • Chicago, Illinois, United States, 60026
        • Clinical Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Clinical Research Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Clinical Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Clinical Research Site
      • Boston, Massachusetts, United States, 02115
        • Clinical Research Site
    • New York
      • New York, New York, United States, 10016
        • Clinical Research Site
      • New York, New York, United States, 10029
        • Clinical Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Clinical Research Site
      • Greensboro, North Carolina, United States, 27403
        • Clinical Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Clinical Research Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Clinical Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Clinical Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Clinical Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Clinical Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Clinical Research Site
      • Houston, Texas, United States, 77030
        • Clinical Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84132-0001
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants willing and able to provide informed consent

  • 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 one of the following:

    1. Idiopathic interstitial pneumonia (IIP)
    2. Chronic hypersensitivity pneumonitis
    3. ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) < 70% of predicted
  • Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
  • Ability to perform 6MWT ≥100 meters.

Exclusion Criteria:

  • Diagnosis of WHO 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).
  • Exacerbation of underlying lung disease requiring augmentation of therapy or emergent hospitalization within 28 days prior to randomization.
  • Initiation of pulmonary rehabilitation within 28 days prior to randomization.
  • Receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
  • History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators.
  • Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mosliciguat
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Drug: Mosliciguat
Dose level 1, 2, or 3 for inhalation
Device: Dry Powder Inhaler
Dry powder inhaler for mosliciguat or placebo delivery
Placebo Comparator: Matched Placebo
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Device: Dry Powder Inhaler
Dry powder inhaler for mosliciguat or placebo delivery
Drug: Placebo
Matching placebo for inhalation
Experimental: Extension
After Week 24, all participants may receive mosliciguat through an Extension period
Drug: Mosliciguat
Dose level 1, 2, or 3 for inhalation
Device: Dry Powder Inhaler
Dry powder inhaler for mosliciguat or placebo delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
Time Frame: Baseline, Week 16
PVR evaluated using right heart catheterization (RHC).
Baseline, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time Frame: Baseline, Week 16
The NT-proBNP serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 16.
Baseline, Week 16
Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)
Time Frame: Baseline, Week 16
The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.
Baseline, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulmovant, Inc.

Investigators

  • Study Director: Ubaldo Martin, MD, Pulmovant, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Actual)

May 26, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVT-2301-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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