A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: inhaled mosliciguat, Dry Powder Inhaler.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension, Interstitial Lung Disease (ILD), Lung Diseases, Vascular Diseases. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Phase 2 Study Evaluating the Safety of Mosliciguat in Combination With Inhaled Treprostinil in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Overview
This is a Phase 2, open-label, multi-center clinical study to evaluate the safety and tolerability of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.
Detailed description
This study is an open-label study with an extension.
The study consists of 2 periods: an open label treatment period (16 weeks) and an extension (beyond 16 weeks).
Participants will receive mosliciguat in the 16-week treatment period.
All participants who complete the 16-week treatment period may continue to participate in the extension period where all participants will receive mosliciguat.
Interventions
- Drug inhaled mosliciguat
Dose level 1, 2, or 3 for inhalation - Device Dry Powder Inhaler
Dry powder inhaler for mosliciguat delivery
Primary outcome measures
- Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation [Time frame: Baseline, Week 16]
Eligibility criteria
Inclusion criteria
- Participants willing and able to provide informed consent
- Participants on inhaled treprostinil
- 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:
- 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 6MWD ≥100 meters.
Exclusion criteria
- 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).
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC — Kissimmee
Identifiers
NCT: NCT07333183 · RVT-2301-202