Pulmonary HypertensionPhase 2PHocusNCT06635850
A Study of Mosliciguat in PH-ILD
A Phase 2 study testing Mosliciguat and Dry Powder Inhaler in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Pulmovant, Inc. at 85 sites in 20 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases
- What is being tested?
- Mosliciguat and Dry Powder Inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 85 sitesin 20 countries
- Study dates
- 29 Oct 2024to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Idiopathic interstitial pneumonia (IIP)
- Chronic hypersensitivity pneumonitis
- 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.
Who cannot join
- 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.
Trial locations and contacts
85 sites in 20 countries.
85 sites in 20 countries
United States25 sites
Clinical Research Site
Bend, Oregon, 97701
Clinical Research Site
Boston, Massachusetts, 02111
Clinical Research Site
Boston, Massachusetts, 02115
Clinical Research Site
Celebration, Florida, 34746
Clinical Research Site
Charleston, South Carolina, 29425
Clinical Research Site
Chicago, Illinois, 60026
Clinical Research Site
Cincinnati, Ohio, 45267
Clinical Research Site
Dallas, Texas, 75390
Clinical Research Site
Durham, North Carolina, 27710
Clinical Research Site
East Providence, Rhode Island, 02915
Clinical Research Site
Greensboro, North Carolina, 27403
Clinical Research Site
Houston, Texas, 77030
Clinical Research Site
Iowa City, Iowa, 52242
Clinical Research Site
Kansas City, Kansas, 66160
Clinical Research Site
Los Angeles, California, 90024
Clinical Research Site
Louisville, Kentucky, 40202
Clinical Research Site
New York, New York, 10016
Clinical Research Site
New York, New York, 10029
Clinical Research Site
Philadelphia, Pennsylvania, 19140
Clinical Research Site
Phoenix, Arizona, 85012
Clinical Research Site
Sacramento, California, 95817
Clinical Research Site
Salt Lake City, Utah, 84132-0001
Clinical Research Site
Santa Barbara, California, 93105
Clinical Research Site
Torrance, California, 90502
Clinical Research Site
Washington D.C., District of Columbia, 20037
Japan7 sites
Clinical Research Site
Chiyoda City, Tokyo, 102-0071
Clinical Research Site
Kobe, Hyōgo, 650-0017
Clinical Research Site
Narashino, Chiba, 2758580
Clinical Research Site
Okayama, Okayama-ken, 701-1192
Clinical Research Site
Sapporo, Hokkaido, 060-8648
Clinical Research Site
Suita, Osaka, 564-8565
Clinical Research Site
Yokohama, Kanagawa, 236-0051
Italy5 sites
Clinical Research Site
Genova, Genoa, 16132
Clinical Research Site
Naples, 80131
Clinical Research Site
Palermo, 90127
Clinical Research Site
Pavia, Lombardy, 27100
Clinical Research Site
Roma, 00161
United Kingdom5 sites
Clinical Research Site
Cambridge, England, CB2 0AY
Clinical Research Site
Clydebank, Scotland, G81 4DY
Clinical Research Site
London, England, NW3 2QG
Clinical Research Site
London, England, SW3 6NP
Clinical Research Site
London, England, W12 0HS
Brazil4 sites
Clinical Research Site
Blumenau, Santa Catarina, 89010-906
Clinical Research Site
Porto Alegre, Rio Grande do Sul, 90020090
Clinical Research Site
São Paulo, 04024-002
Clinical Research Site
São Paulo, 05403-904
France4 sites
Clinical Research Site
Bron, Auvergne-Rhône-Alpes, 69677
Clinical Research Site
Le Kremlin-Bicêtre, Île-de-France Region, 94270
Clinical Research Site
Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42270
Clinical Research Site
Strasbourg, Bas-Rhin, 67091
Germany4 sites
Clinical Research Site
Dresden, Saxony, 01307
Clinical Research Site
Halle, Saxony-Anhalt, 06120
Clinical Research Site
Heidelberg, Baden-Wurttemberg, 69126
Clinical Research Site
München, Bavaria, 81377
South Korea4 sites
Clinical Research Site
Dongjak, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 7061
Clinical Research Site
Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], 21565
Clinical Research Site
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 06351
Clinical Research Site
Seoul, Seoul-Teukbyeolsi, 05505
Spain4 sites
Clinical Research Site
Madrid, 28041
Clinical Research Site
Marbella, Málaga, 29603
Clinical Research Site
Santander, Cantabria, 39008
Clinical Research Site
Toledo, 45007
Australia3 sites
Clinical Research Site
Auchenflower, Queensland, 4066
Clinical Research Site
Sydney, New South Wales, 2050
Clinical Research Site
Westmead, New South Wales, 2145
Canada3 sites
Clinical Research Site
Calgary, Alberta, T1Y 6J4
Clinical Research Site
London, Ontario, N6A 5W9
Clinical Research Site
Toronto, Ontario, M5G 2C4
Poland3 sites
Clinical Research Site
Lodz, Lódzkie, 91-347
Clinical Research Site
Otwock, Masovian Voivodeship, 05-400
Clinical Research Site
Poznan, Greater Poland Voivodeship, 61 848
Argentina2 sites
Clinical Research Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426
Clinical Research Site
Santa Fe, S3000EOZ
Belgium2 sites
Clinical Research Site
Brussels, Brussels Capital, 1070
Clinical Research Site
Leuven, Flanders, 3000
Czechia2 sites
Clinical Research Site
Prague, Prague, 128 08
Clinical Research Site
Prague, Prague, 140 59
Netherlands2 sites
Clinical Research Site
Amsterdam, North Holland, 1081 HV
Clinical Research Site
Nijmegen, Gelderland, 6500 HB
New Zealand2 sites
Clinical Research Site
Christchurch, Canterbury, 8041
Clinical Research Site
Hamilton, Waikato Region, 3240
Turkey (Türkiye)2 sites
Clinical Research Site
Bornova, İzmir, 35100
Clinical Research Site
Pendik, Istanbul, 34899
About this study
Official 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
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).
Read the 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.
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis
- Being tested
- Mosliciguat, Dry Powder Inhaler, Placebo
- Keywords
- PH, ILD, 6 Minute Walk Test, mosliciguat
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosliciguatDrug
Dose level 1, 2, or 3 for inhalation
Dry Powder InhalerDevice
Dry powder inhaler for mosliciguat or placebo delivery
PlaceboDrug
Matching placebo for inhalation
| Study group | Role | What they receive |
|---|---|---|
| Mosliciguat | Active comparator | Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks Receives: Drug: Mosliciguat; Device: Dry Powder Inhaler |
| Matched Placebo | Placebo comparator | Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks Receives: Device: Dry Powder Inhaler; Drug: Placebo |
| Extension | Experimental | After Week 24, all participants may receive mosliciguat through an Extension period Receives: Drug: Mosliciguat; Device: Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
PVR evaluated using right heart catheterization (RHC).
Measured: Baseline, Week 16
Secondary outcomes (2)
Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)
The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.
Measured: Baseline, Week 16
Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
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.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start29 Oct 2024
- Primary completion26 May 2026
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmovant, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ubaldo Martin, MD, Study director, Pulmovant, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635850
- Sponsor's protocol ID
- RVT-2301-201
- Acronym
- PHocus
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06635850
- Acronym / sponsor ID
- PHocus / RVT-2301-201
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis
- Keywords
- PH, ILD, 6 Minute Walk Test, mosliciguat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Pulmovant, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mosliciguat | Active comparator | Drug: Mosliciguat, Device: Dry Powder InhalerParticipants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks |
| Matched Placebo | Placebo comparator | Device: Dry Powder Inhaler, Drug: PlaceboParticipants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks |
| Extension | Experimental | Drug: Mosliciguat, Device: Dry Powder InhalerAfter Week 24, all participants may receive mosliciguat through an Extension period |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
- Ability to perform 6MWT ≥100 meters.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MosliciguatDose level 1, 2, or 3 for inhalation | Drug | Extension, Mosliciguat |
| Dry Powder InhalerDry powder inhaler for mosliciguat or placebo delivery | Device | Extension, Matched Placebo, Mosliciguat |
| PlaceboMatching placebo for inhalation | Drug | Matched Placebo |
Primary outcome
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
Time frame: Baseline, Week 16
PVR evaluated using right heart catheterization (RHC).
2 secondary outcomes
Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)
Time frame: Baseline, Week 16
Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: Baseline, Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ubaldo Martin, MD study director
Pulmovant, Inc.
85 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mosliciguat and Dry Powder Inhaler in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Pulmovant, Inc. at 85 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, Japan, Italy, United Kingdom, Brazil and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.