Authorised Therapeutic exploratory (Phase II) Pulmonary Hypertension Associated with Interstitial Lung Disease

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

EU CTIS ID: 2024-513991-16-00

What this study is testing

Determine the magnitude of reduction in PVR at 16 weeks

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Participants willing and able to provide informed consent.
  • 2. 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: a.Idiopathic interstitial pneumonia (IIP). b.Chronic hypersensitivity pneumonitis. c.ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) <70% of predicted.
  • 3. Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
  • 4. Ability to perform 6MWD ≥ 100 meters.

You likely can't join if

  • 1. 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).
  • 2. Exacerbation of underlying lung disease requiring augmentation of therapy or emergent hospitalization within 28 days prior to randomization.
  • 3. Initiation of pulmonary rehabilitation within 28 days prior to randomization.
  • 4. Receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
  • 5. History or intolerance to mosliciguat or sGC stimulators or activators.
  • 6. Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization.

The study team makes the final eligibility decision.

Where it's taking place

  • Canada
  • Korea, Republic of
  • New Zealand
  • United Kingdom
  • Japan
  • United States
  • Brazil
  • Turkey
  • Argentina
  • Australia
  • Mexico

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Canada; Korea, Republic of; New Zealand; United Kingdom; Japan; United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.