A Study of Mosliciguat in PH-ILD

Last updated: October 9, 2024
Sponsor: Pulmovant, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Vascular Diseases

Pulmonary Arterial Hypertension

Circulation Disorders

Treatment

Mosliciguat

Dry Powder Inhaler

Placebo

Clinical Study ID

NCT06635850
RVT-2301-201
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants willing and able to provide informed consent

  • Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will beconfirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuseparenchymal disease. Eligible diagnosed diseases include:

  1. Idiopathic interstitial pneumonia (IIP)

  2. Chronic hypersensitivity pneumonitis

  3. ILD associated with connective tissue disease (CTD) with a forced vitalcapacity (FVC) < 70% of predicted

  • Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).

  • Ability to perform 6MWD ≥100 meters.

Exclusion

Exclusion Criteria:

  • Diagnosis of PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related toleft-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonaryhypertension), or Group 5 (eg, unclassified).

  • Exacerbation of underlying lung disease 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 atBaseline.

  • History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators oractivators.

  • Receipt of investigational, or experimental therapy within 42 days OR 5 half-livesprior to randomization.

Note: Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Mosliciguat
Phase: 2
Study Start date:
November 01, 2024
Estimated Completion Date:
January 31, 2028

Study 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.

Connect with a study center

  • PulmonIx

    Greensboro, North Carolina 27403
    United States

    Active - Recruiting

  • Summit Health

    Bend, Oregon 97701
    United States

    Active - Recruiting

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