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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02700529
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : February 6, 2020
Information provided by (Responsible Party):
Eiger BioPharmaceuticals

Brief 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

Condition or disease Intervention/treatment Phase
Lymphedema Drug: ubenimex Other: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : June 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: ubenimex
ubenimex capsules 150 mg three times a day (TID), administered orally for a total of 24 weeks.
Drug: ubenimex
Placebo Comparator: placebo
matched placebo capsules TID, administered orally for a total of 24 weeks
Other: placebo

Primary Outcome Measures :
  1. Change in skin thickness of the calf of the most affected leg, measured by skinfold calipers [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Change in lymphedema-specific patient reported outcome measures (Patient-Reported Evaluation of Lymphedema [Leg]) questionnaire results [ Time Frame: Week 24 ]
  2. Change in leg volume of the most affected leg [ Time Frame: Week 24 ]
  3. Change in extracellular fluid volume of the lower limb, measured by the bioimpedance spectroscopy device. [ Time Frame: Week 24 ]
  4. Change in biospy result for dermal thickness [ Time Frame: Week 24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Swelling of at least 1 leg not completely reversed by leg elevation or compression.
  3. Stage II or greater lymphedema, based on the International Society of Lymphology (ISL) staging system.
  4. Completion of a full course of complete decongestive therapy (CDT).
  5. Stable limb volume (within 10% during screening for worse/affected leg) .
  6. 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.
  7. Ambulatory status (use of a walking aid is permitted).
  8. Agree to use a medically acceptable method of contraception, if the possibility of conception exists.

Exclusion Criteria:

Exclusions Based on Lymphedema:

  1. 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)
  2. Occurrence of significant lymphedema of another body part that is not the lower limb (e.g, upper extremity, trunk, head and neck, genitalia).
  3. Lymphedema involving all four limbs
  4. Recent initiation of, or intention to initiate CDT or maintenance physiotherapy for lymphedema.

    Exclusions Based on Other Medical Conditions

  5. Deep venous thrombosis in either lower limb or systemic anticoagulation within 6 months
  6. Other medical condition that could lead to acute or chronic leg edema.
  7. Other medical condition that could result in symptoms overlapping those of lymphedema in the affected leg.
  8. History of clotting disorder (hypercoagulable state).
  9. Chronic (persistent) infection in either lower limb.
  10. Cellulitis or other infection in either lower limb or use of antibiotics for cellulitis within 3 months prior to screening.
  11. Other unstable or severe medical condition requiring active management and/or likely to decompensate/require active management within the next year
  12. Current evidence of malignancy.
  13. History of malignancy within the previous 3 years, except for nonmelanoma skin cancer or cervical carcinoma in situ treated with curative intent.
  14. Currently receiving chemotherapy or radiation therapy.
  15. Life expectancy < 2 years for any reason.
  16. Pregnancy or nursing.
  17. Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening.

    Exclusions Based on Concurrent Medication Use

  18. Regular concurrent use or regular use within 6 months before screening of another leukotriene pathway inhibitor.
  19. Concurrent antibiotic use.
  20. Concurrent use of any agent active on the sphingosine-1-phosphate (S1P) pathway.
  21. Concurrent use of unapproved (including herbal) treatments for lymphedema.

    Exclusions Based on Laboratory Values

  22. Significant or chronic renal insufficiency or requires dialytic support.
  23. Hepatic dysfunction.
  24. Absolute neutrophil count <1500 mm3 at screening.
  25. Hemoglobin concentration <9 g/dL at screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02700529

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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Florida
Orlando Health, Inc.
Orlando, Florida, United States, 32806
United States, Ohio
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, United States, 43210
Australia, New South Wales
Macquarie University Hospital (MUH)
Sydney, New South Wales, Australia, 2109
Sponsors and Collaborators
Eiger BioPharmaceuticals
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Responsible Party: Eiger BioPharmaceuticals Identifier: NCT02700529    
Other Study ID Numbers: EIG-UBX-003
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Lymphatic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents