A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)

NCT07816185 | Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: RVT-2301-301
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 3

Brief Summary

A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

Conditions

Pulmonary Hypertension; Interstitial Lung Disease; Vascular Diseases; Cardiovascular Diseases; Fibrosis

Keywords

PH; ILD; 6 Minute Walk Distance; mosliciguat

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in 6-Minute Walk Distance (6MWD)

  The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes

  Baseline to Week 24

Secondary Outcomes (4)

• Time to Clinical Worsening (TTCW)

  From randomization through Week 24

• Percent Change from Baseline in Pulmonary Vascular Resistance (PVR)

  Baseline to Week 24

• Change from Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)

  Baseline to Week 24

• Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score

  Baseline to Week 24

Study Arms (3)

Mosliciguat

ACTIVE COMPARATOR

Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks

Drug: Mosliciguat; Device: Dry Powder Inhaler

Matched Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks

Drug: Placebo; Device: Dry Powder Inhaler

Extension

EXPERIMENTAL

After Week 24, all participants may receive mosliciguat through an Extension period

Drug: Mosliciguat; Device: Dry Powder Inhaler

Interventions

Mosliciguat DRUG

Dose level 1, 2, or 3 for inhalation

Extension; Mosliciguat

Placebo DRUG

Matching Placebo for inhalation

Matched Placebo

Dry Powder Inhaler DEVICE

Administration via dry powder inhaler

Extension; Matched Placebo; Mosliciguat

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants willing and able to provide informed consent.
• Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include:
• Idiopathic interstitial pneumonia (IIP)
• Chronic Hypersensitivity pneumonitis
• ILD associated connective tissue disease (CTD)
• Confirmed pulmonary hypertension by right heart catheterization (RHC).
• Ability to perform 6-minute walk distance ≥100 meters.

You may not qualify if:

• Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
• Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization
• Receiving \>10 L/min oxygen supplementation by any mode of delivery at rest
• History of intolerance to mosliciguat, or sGC stimulators or activators.
• Initiation of pulmonary rehabilitation or ongoing acute phase of rehabilitation within 28 days prior to randomization.
• Receipt of investigational or interventional therapy within 42 days OR 5 half-lives (whichever is longer) prior to randomization.

Sponsors & Collaborators

• Pulmovant, Inc.: lead

Study Sites (3)

Clinical Research Site

Kissimmee, Florida, 34746, United States

RECRUITING

Clinical Research Site

Louisville, Kentucky, 40202, United States

RECRUITING

Clinical Research Site

Bend, Oregon, 97701, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial; Vascular Diseases; Cardiovascular Diseases; Fibrosis

Interventions

Dry Powder Inhalers

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• Ubaldo Martin

  Pulmovant, Inc.

  STUDY DIRECTOR

Central Study Contacts

Pulmovant Inc

CONTACT

+1-919-462-1310; clinicaltrials@pulmovant.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): January 28, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)