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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pulmovant Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

17 Jan 2025 → ongoing

Decision date (initial)

2024-12-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pulmovant, Inc.

External identifiers

EU CT number

2024-513991-16-00

ClinicalTrials.gov

NCT06635850

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacogenomic, Efficacy, Pharmacokinetic

Determine the magnitude of reduction in PVR at 16 weeks

Secondary objectives 2

1. 1. Determine the improvement in 6-Minute Walk Distance (6MWD) at 16 weeks
2. 2. Determine change in N-terminal pro-brain natriuretic peptide (NT-proBNP) at 16 weeks

Conditions and MedDRA coding

Pulmonary Hypertension Associated with Interstitial Lung Disease

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. Participants willing and able to provide informed consent.
2. 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. 3. Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
4. 4. Ability to perform 6MWD ≥ 100 meters.

Exclusion criteria 6

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change from baseline in PVR assessed at estimated peak exposure at Week 16 (%ΔPVR16) by right heart catheterization (RHC)

Secondary endpoints 2

1. 1. Change in 6MWD from baseline measured at estimated peak exposure at Week 16 using the 6-Minute Walk Test (6MWT)
2. 2. Change from baseline in NT-proBNP at Week 16

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pulmovant Inc.

Sponsor organisation

Pulmovant Inc.

Address

303 Wyman Street Suite 300

City

Waltham

Postcode

02451-1255

Country

United States

Scientific contact point

Organisation

Pulmovant Inc.

Contact name

Pulmovant Clinical Operations

Public contact point

Organisation

Pulmovant Inc.

Contact name

Pulmovant Clinical Operations

Third parties 12

Locations

9 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 236 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications