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

NCT ID: NCT03789643

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2021-06-30

Brief Summary

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

Detailed 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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

JTT-251 Dose 1

One dose of study drug by mouth daily for 24 weeks

Group Type: EXPERIMENTAL

JTT-251

Intervention Type: DRUG

Active drug tablets containing JTT-251

JTT-251 Dose 2

One dose of study drug by mouth daily for 24 weeks

Group Type: EXPERIMENTAL

JTT-251

Intervention Type: DRUG

Active drug tablets containing JTT-251

JTT-251 Dose 3

One dose of study drug by mouth daily for 24 weeks

Group Type: EXPERIMENTAL

JTT-251

Intervention Type: DRUG

Active drug tablets containing JTT-251

Placebo

One dose of study drug by mouth daily for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets matching in appearance to the active drug tablets

Interventions

JTT-251

Active drug tablets containing JTT-251

Intervention Type: DRUG

Placebo

Placebo tablets matching in appearance to the active drug tablets

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akros Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AT251-G-17-006

Identifier Type: -

Identifier Source: org_study_id