A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPulmovant, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants willing and able to provide informed consent

Participants on inhaled treprostinil

Idiopathic interstitial pneumonia (IIP)

Chronic hypersensitivity pneumonitis

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • inhaled mosliciguat

    Drug

    Dose level 1, 2, or 3 for inhalation

  • Dry Powder Inhaler

    Device

    Dry powder inhaler for mosliciguat delivery

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Active Comparator: inhaled mosliciguatExperimental treatment 2 interventions
Group B: Extension: inhaled mosliciguatExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation

Time frame
Baseline, Week 16

Secondary outcomes

Other outcomes

Sponsors and contacts

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