Previewing Six Pulmonary Hypertension Late-Phase Trials Set To Complete in the United States

It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today, we are previewing six late-phase clinical trials that focus on pulmonary hypertension, with some trials focusing exclusively on pulmonary arterial hypertension. Most of today's featured trials are still recruiting, and all are estimated to complete within the next three years. Trials are arranged by start date.

Quick View Table of Pulmonary Hypertension Clinical Trials

Featured Phase 3 Clinical Trials

A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) (PALM-PAH)

• Sponsor: Insmed Incorporated
• Goal: The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.
• Interventions: Treprostinil Palmitil Inhalation Powder, placebo
• Primary Outcome Measure: Change in six-minute walk distance (6MWD) measured at one to three hours post-dose from baseline at week 24.
• Time Frame: Baseline, week 24.
• Study Details
• Source

Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE) (DONE)

• Sponsor: University of California, Davis
• Goal: This pilot randomized clinical trial compares dopamine and norepinephrine as first-line vasoactive therapies in term and late preterm neonates with pulmonary hypertension associated with hypoxemic respiratory failure and systemic hypotension.
• Interventions: Dopamine administration, norepinephrine
• Primary Outcome Measures: SAP/PAP ratio; LV cardiac output; Oxygenation indices.
• Time Frames: Within 30 hours of vasopressor initiation; Within 30 hours of vasopressor initiation; Within 30 hours of vasopressor initiation.
• Study Details
• Source

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH) (IMPROVE-PAH)

• Sponsor: Inhibikase Therapeutics
• Goal: This is an adaptive, 2-part, randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of IKT-001 in adult participants with WHO Group 1 PAH.
• Interventions: IKT-001, placebo
• Primary Outcome Measures: To evaluate the effect on Pulmonary Vascular Resistance (PVR) in participants with WHO Group 1 PAH treated with IKT-001 compared to placebo; To characterize the effects of IKT-001 on symptoms and characteristics of Pulmonary Arterial Hypertension compared to placebo.
• Time Frames: Baseline to week 24; Baseline to week 24.
• Study Details
• Source

Long-Term Open-Label Extension Study of Oral Levosimendan

• Sponsor: Tenax Therapeutics
• Goal: The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) who received TNX-103 in a parent study.
• Intervention: TNX-103
• Primary Outcome Measure: The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs.
• Time Frame: From enrollment through study completion (up to three years).
• Study Details
• Source

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) (SOTERIA)

• Sponsor: Merck Sharp & Dohme
• Goal: The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.
• Intervention: Sotatercept
• Primary Outcome Measures: Number of participants who experience an adverse event (AE); Number of participants who discontinue study treatment due to an AE; Number of participants with detectable anti-drug antibodies (ADAs); Laboratory parameters (hematology): Concentration of platelets and hemoglobin; Laboratory parameters (chemistry): Concentration of creatinine, total bilirubin, and alanine aminotransferase (ALT); Change from baseline in body weight; Change from baseline in blood pressure; Change from baseline in electrocardiogram (ECG).
• Time Frames: Up to approximately 90 months; Up to approximately 86 months; Up to approximately 88 months; Up to approximately 88 months; Up to approximately 86 months; Baseline and up to approximately 86 months; Baseline and up to approximately 86 months; Baseline and up to approximately 86 months.
• Study Details
• Source

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

• Sponsor: GB002
• Goal: This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study.
• Interventions: Seralutinib, gereic dry powder inhaler
• Primary Outcome Measure: Incidence of treatment-emergent adverse events (TEAEs).
• Time Frame: From baseline to end of study (up to 48 months or availability of commercial product).
• Study Details
• Source

Related Guidelines:

• Therapy for Pulmonary Arterial Hypertension in Adults
  • American College of Chest Physicians (CHEST)
  • January 2019

• Pulmonary Hypertension in Chronic Lung Disease and Hypoxia
  • European Respiratory Society (ERS)
  • January 2019

• Risk Stratification and Medical Therapy of Pulmonary Arterial Hypertension
  • European Respiratory Society (ERS)
  • January 2019

Don’t miss out on our other pulmonology-related content and be sure to sign up for alerts and stay informed on the latest published guidelines.