Last updated on October 2018

Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)

Brief description of study

Leukotriene B4 (LTB4) inhibits lymphangiogenesis in the mouse tail model of lymphedema and is elevated in tissue in patients with lymphedema. Ubenimex is an inhibitor of leukotriene A4 hydrolase (LTA4H), the biosynthetic enzyme for LTB4. This proof-of-concept study is designed as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients with leg lymphedema. The primary objectives for the study are: - To evaluate the efficacy of ubenimex in patients with leg lymphedema - To evaluate the safety and tolerability of ubenimex in patients with leg lymphedema

Clinical Study Identifier: NCT02700529

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Leslie Jacome-Roche

Stanford University
Stanford, CA United States

Jennifer Quintiliani

Orlando Health, Inc.
Orlando, FL United States

Filiz Muharrem

The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, OH United States

Louise Koelmeyer

Macquarie University Hospital (MUH)
Macquarie University, Australia