Trial ID or NCT#





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 secondary leg lymphedema.


The primary objectives for the study are to evaluate the efficacy, safety and tolerability of ubenimex in patients with secondary leg lymphedema. 

Official Title

Ubenimex in Adult Patients With Lymphedema of The Lower Limb: a Phase 2, RAndomized, Double-blind, Placebo-controlled Study of Efficacy, Safety, and Pharmacokinetics (ULTRA)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No


Stanley G. Rockson, MD
Allan and Tina Neill Professor of Lymphatic Research and Medicine

Contact us to find out if this trial is right for you.


Les Roche, RN
(650) 723-1396