Study to Evaluate Efficacy and Safety of JTT-251 in Parti... | NCT03789643

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

NCT03789643

Sponsor

Akros Pharma Inc.

Status

Withdrawn

Last Update Posted

May 3, 2019Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Pulmonary Arterial Hypertension

Interventions

JTT-251
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Corporate decision, priority change

Expanded Access Info

Start Date

Mar 2019Estimated

Primary Completion Date

Mar 2021Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Dec 26, 2018

First Submission Date that Met QC Criteria

Dec 26, 2018

First Posted Date

Dec 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2019

Last Update Posted Date

May 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JTT-251 Dose 1	Experimental	One dose of study drug by mouth daily for 24 weeks	Drug: JTT-251
JTT-251 Dose 2	Experimental	One dose of study drug by mouth daily for 24 weeks	Drug: JTT-251
JTT-251 Dose 3	Experimental	One dose of study drug by mouth daily for 24 weeks	Drug: JTT-251
Placebo	Placebo Comparator	One dose of study drug by mouth daily for 24 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JTT-251	Drug	Active drug tablets containing JTT-251	JTT-251 Dose 1 JTT-251 Dose 2 JTT-251 Dose 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in six-minute walk distance (6MWD) compared to baseline		24 Weeks
Change in World Health Organization (WHO) functional classification compared to baseline		24 Weeks
Change in pulmonary vascular resistance (PVR) compared to baseline	Assessed by right heart catheterization (RHC)	4, 12, 24 and 28 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of adverse events		28 Weeks
JTT-251 trough plasma concentrations		4, 12 and 24 Weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases