A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

This proof-of-concept study is designed as a Phase 2, multicenter, randomized, double-blind, placebo controlled study comparing ubenimex with placebo in patients with pulmonary arterial hypertension (PAH) (World Health Organization \[WHO\] Group 1) and have a WHO/New York Heart Association (NYHA) Functional Classification (WHO/NYHA-FC) of II or III.

Key facts

Study ID

NCT02664558

Run by

Eiger BioPharmaceuticals

People needed

61

Starts

2016-04-01

Expected to finish

2018-01-01

Last updated by the study team

2023-03-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18-75 years old.
• Has a diagnosis of WHO Group 1 PAH.
• Right heart catheterization performed at Screening with results that are:
• Mean pulmonary arterial pressure ≥25 mmHg (at rest) and
• Pulmonary venous hypertension (measured as pulmonary capillary wedge pressure (PCWP) ≤15 mmHg. If PCWP is not available, then mean left atrial pressure or left ventricular end-diastolic pressure ≤15 mmHg in the absence of left atrial obstruction. and
• Pulmonary vascular resistance (PVR) ≥300 dyn•s/cm5 (3.75 Wood units)
• Has WHO/NYHA-FC of II or III.
• Be on stable dose of at least one of the following PAH-specific therapies: endothelin receptor antagonist, an agent acting on the nitric oxide pathway (phosphodiesterase type 5 inhibitor or soluble guanylate cyclase stimulator), and/or a prostacyclin or prostacyclin analog.
• Has a 6-minute walk distance that is ≥150 and ≤500 meters.
• Have a ventilation-perfusion scan that rules out thromboembolic disease.

You may not qualify if…

• Exclusions Related to Cardiovascular Disease
• History of uncontrolled hypertension
• Persistent hypotension at Screening.
• Evidence or history of left-sided heart disease and/or clinically significant cardiac disease in which pulmonary hypertension is more likely WHO Group 2.
• Acute decompensated heart failure within 1 month of Screening.
• Recent initiation (<8 weeks from Screening) or planned initiation of cardiopulmonary rehabilitation exercise program.
• Exclusions Related to Pulmonary Disease
• Newly diagnosed with PAH and not on PAH-specific therapy.
• Pulmonary hypertension due to:
• Uncorrected congenital systemic-to-pulmonary shunt.
• Pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis
• Persistent pulmonary hypertension of the newborn
• WHO clinical classification Groups 2-5
• Evidence of significant airway and/or parenchymal lung disease.
• Chronic infection related to tuberculosis or fungal or mycobacterial disease.
• Exclusions Based on Other Medical Conditions
• Chronic infections including, but not limited to tuberculosis (TB), hepatitis B virus (HBV) or hepatitis C virus (HCV).
• History of portal hypertension or chronic liver disease, including positive serology for infection with HCV and/or HBV.
• Evidence of active infection requiring intravenous or oral antibiotics within 4 weeks of Screening.
• Body mass index ≥35.0 at Screening.
• History of obstructive sleep apnea.
• History of malignancy within the last 5 years, except nonmelanoma skin cancer and cervical carcinoma in situ treated with curative intent.
• Neuropsychiatric disorders/symptoms or psychological conditions.
• Pregnancy or breast-feeding
• Prior treatment with B cell or lymphocyte-depleting agents (eg, rituximab, Campath)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• California Heart Center Foundation, An Affiliate of Cedars-Sinai Heart Institute, Cedars-Sinai Medical Care Foundation — Beverly Hills, California, United States
• UCSD Medical Center — La Jolla, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Cleveland Clinic, Florida — Weston, Florida, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• Chest Medicine Associates — South Portland, Maine, United States
• Johns Hopkins University, Pulmonary and Critical Care Medicine — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic College of Medicine — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Weill Cornell Medicine — New York, New York, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Respiratory Institute — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pennsylvania Medical Center — Pittsburgh, Pennsylvania, United States
• Alpert Medical School of Brown University Rhode Island Hospital — Providence, Rhode Island, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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