Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789643
Recruitment Status : Withdrawn (Corporate decision, priority change)
First Posted : December 28, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.

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)

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: JTT-251 Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: JTT-251 Dose 1
One dose of study drug by mouth daily for 24 weeks
Drug: JTT-251
Active drug tablets containing JTT-251

Experimental: JTT-251 Dose 2
One dose of study drug by mouth daily for 24 weeks
Drug: JTT-251
Active drug tablets containing JTT-251

Experimental: JTT-251 Dose 3
One dose of study drug by mouth daily for 24 weeks
Drug: JTT-251
Active drug tablets containing JTT-251

Placebo Comparator: Placebo
One dose of study drug by mouth daily for 24 weeks
Drug: Placebo
Placebo tablets matching in appearance to the active drug tablets




Primary Outcome Measures :
  1. Change in six-minute walk distance (6MWD) compared to baseline [ Time Frame: 24 Weeks ]
  2. Change in World Health Organization (WHO) functional classification compared to baseline [ Time Frame: 24 Weeks ]
  3. Change in pulmonary vascular resistance (PVR) compared to baseline [ Time Frame: 4, 12, 24 and 28 Weeks ]
    Assessed by right heart catheterization (RHC)


Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 28 Weeks ]
  2. JTT-251 trough plasma concentrations [ Time Frame: 4, 12 and 24 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Layout table for additonal information
Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT03789643     History of Changes
Other Study ID Numbers: AT251-G-17-006
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akros Pharma Inc.:
JTT-251
Pulmonary arterial hypertension
RELIEF-PAH
Six-minute walk distance (6MWD)
Additional relevant MeSH terms:
Layout table for MeSH terms
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases