NCT02700529

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Eiger BioPharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Lymphedema

Interventions

Type	Name	Description
DRUG	ubenimex
OTHER	placebo

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-10-01
• Completion: 2019-02-01
• First posted: 2016-03-07
• Last updated: 2023-01-18
• Results posted: 2023-01-18

Locations

4 sites across 2 countries: United States, Australia