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

NCT03789643 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: AT251-G-17-006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Pulmonary Arterial Hypertension

Keywords

JTT-251; Pulmonary arterial hypertension; RELIEF-PAH; Six-minute walk distance (6MWD)

Outcome Measures

Primary Outcomes (3)

• 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 (2)

• Number of adverse events

  28 Weeks

• JTT-251 trough plasma concentrations

  4, 12 and 24 Weeks

Study Arms (4)

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

JTT-251 DRUG

Active drug tablets containing JTT-251

JTT-251 Dose 1; JTT-251 Dose 2; JTT-251 Dose 3

Placebo DRUG

Placebo tablets matching in appearance to the active drug tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akros Pharma Inc.: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 28, 2018
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share