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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lymphedema

In brief

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.

Key facts

Study ID

NCT02700529

Run by

Eiger BioPharmaceuticals

People needed

54

Starts

2016-06-01

Expected to finish

2019-02-01

Last updated by the study team

2023-01-18

Who can join

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

You may qualify if…

• Has a diagnosis of secondary leg lymphedema, based on a positive lymphoscintigraphy (LSG) study of the affected leg OR has a diagnosis of primary lymphedema not of congenital onset affecting one or both lower limbs, based on positive LSG.
• Swelling of at least 1 leg not completely reversed by leg elevation or compression.
• Stage II or greater lymphedema, based on the International Society of Lymphology (ISL) staging system.
• Completion of a full course of complete decongestive therapy (CDT).
• Stable limb volume (within 10% during screening for worse/affected leg) .
• If patient has had a lymphatic vascularization procedure (lymphovenous bypass or lymph node transfer) or liposuction for lymphedema in the affected limb, then procedure must have been performed at least 1 year (12 months) prior to Screening AND affected limb must be clinically stable over the 3 months prior to Screening AND significant residual disease must be present.
• Ambulatory status (use of a walking aid is permitted).
• Agree to use a medically acceptable method of contraception, if the possibility of conception exists.

You may not qualify if…

• Exclusions Based on Lymphedema:
• A diagnosis of primary lymphedema with congenital onset. Primary lymphedema is defined as lymphedema with onset prior to or without an inciting event (e.g, surgery, trauma, radiation)
• Occurrence of significant lymphedema of another body part that is not the lower limb (e.g, upper extremity, trunk, head and neck, genitalia).
• Lymphedema involving all four limbs
• Recent initiation of, or intention to initiate CDT or maintenance physiotherapy for lymphedema.
• Exclusions Based on Other Medical Conditions
• Deep venous thrombosis in either lower limb or systemic anticoagulation within 6 months
• Other medical condition that could lead to acute or chronic leg edema.
• Other medical condition that could result in symptoms overlapping those of lymphedema in the affected leg.
• History of clotting disorder (hypercoagulable state).
• Chronic (persistent) infection in either lower limb.
• Cellulitis or other infection in either lower limb or use of antibiotics for cellulitis within 3 months prior to screening.
• Other unstable or severe medical condition requiring active management and/or likely to decompensate/require active management within the next year
• Current evidence of malignancy.
• History of malignancy within the previous 3 years, except for nonmelanoma skin cancer or cervical carcinoma in situ treated with curative intent.
• Currently receiving chemotherapy or radiation therapy.
• Life expectancy < 2 years for any reason.
• Pregnancy or nursing.
• Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening.
• Exclusions Based on Concurrent Medication Use
• Regular concurrent use or regular use within 6 months before screening of another leukotriene pathway inhibitor.
• Concurrent antibiotic use.
• Concurrent use of any agent active on the sphingosine-1-phosphate (S1P) pathway.
• Concurrent use of unapproved (including herbal) treatments for lymphedema.
• Exclusions Based on Laboratory Values

Where it is running

• Stanford University — Stanford, California, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• The Ohio State University Wexner Medical Center James Cancer Hospital — Columbus, Ohio, United States
• Macquarie University Hospital (MUH) — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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