Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— RELIEF-PAH  

Official title:

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03789643
• Other study ID #: AT251-G-17-006
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2019
• Est. completion date: June 2021

Study information

• Verified date: May 2019
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH)

Description:

This is a study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH). Participants completing this study (RELIEF-PAH) will be eligible to enroll in an open-label extension study (RELIEF-PAH OLE) to evaluate the long-term efficacy, safety, tolerability and pharmacokinetics of JTT-251 in participants with PAH.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of PAH as classified by idiopathic, heritable, drug and toxin- induced, congenital heart disease or associated with connective tissue disease (i.e., WHO Group 1)

• Clinical diagnosis of PAH confirmed by RHC at any time prior to Visit 1

• WHO functional status of Class II-IV at Visit 1

• Two 6MWD test measurements between 100 and 450 meters with a relative difference of =15%. The baseline 6MWD test must be performed at Visit 2 before randomization.

• Have a qualifying RHC performed between Visit 1 and Visit 2

• On stable dose(s) of guideline-directed medical therapy for PAH (endothelin receptor antagonists, phosphodiesterase type-5 (PDE-5) inhibitors, soluble guanylate cyclase stimulators and prostacyclin pathway analogs) for at least 90 days prior to the qualifying RHC

Exclusion Criteria:

• PAH associated with portal hypertension, human immunodeficiency virus (HIV), schistosomiasis or sickle cell disease as well as participants with pulmonary parenchymal disease or thromboembolic disease

• Known significant left heart disease including: left ventricular dysfunction (i.e., left ventricular ejection fraction <35%); hemodynamically compromising, symptomatic, or severe aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation

• Pulmonary hypertension belonging to WHO groups 2 to 5

• Moderate to severe obstructive lung disease defined as forced expiratory volume in 1 second (FEV1) <55% of predicted value

• Moderate to severe restrictive lung disease defined as total lung capacity (TLC) <60% of predicted value

• Acute decompensated heart failure or hospital admission for worsening PAH symptoms within 30 days prior to the qualifying RHC

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• JTT-251
Active drug tablets containing JTT-251
• Placebo
Placebo tablets matching in appearance to the active drug tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in six-minute walk distance (6MWD) compared to baseline		24 Weeks
Primary	Change in World Health Organization (WHO) functional classification compared to baseline		24 Weeks
Primary	Change in pulmonary vascular resistance (PVR) compared to baseline	Assessed by right heart catheterization (RHC)	4, 12, 24 and 28 Weeks
Secondary	Number of adverse events		28 Weeks
Secondary	JTT-251 trough plasma concentrations		4, 12 and 24 Weeks