Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)
Status:
Completed
Trial end date:
2019-02-01
Target enrollment:
Participant gender:
Summary
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