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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Eiger BioPharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Eiger BioPharmaceuticals
ClinicalTrials.gov Identifier:
NCT02700529
First received: February 26, 2016
Last updated: March 2, 2017
Last verified: March 2017
  Purpose

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 of ubenimex in patients with secondary leg lymphedema
  • To evaluate the safety and tolerability of ubenimex in patients with secondary leg lymphedema

Condition Intervention Phase
Lymphedema
Drug: ubenimex
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Ubenimex in Adult Patients With Secondary Lymphedema of The Lower Limb: a Phase 2, RAndomized, Double-blind, Placebo-controlled Study of Efficacy, Safety, and Pharmacokinetics (ULTRA)

Resource links provided by NLM:


Further study details as provided by Eiger BioPharmaceuticals:

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

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

Estimated Enrollment: 45
Study Start Date: June 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

Inclusion Criteria:

  1. Secondary leg lymphedema, based on a positive lymphoscintigraphy study of the affected leg.
  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. Ambulatory status (use of a walking aid is permitted).
  7. Presence of an inciting event/risk factor for lymphedema, such as (but not limited to) surgery, trauma, or radiation therapy.
  8. Agree to use a medically acceptable method of contraception, if the possibility of conception exists.

Exclusion Criteria:

Exclusions Based on Lymphedema:

  1. Primary lymphedema, family history, or syndrome including lymphedema.
  2. Occurrence of lymphedema of another body part (e.g, upper extremity, trunk, head and neck, genitalia).
  3. Recent initiation of, or intention to initiate CDT or maintenance physiotherapy for lymphedema.

    Exclusions Based on Other Medical Conditions

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

    Exclusions Based on Concurrent Medication Use

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

    Exclusions Based on Laboratory Values

  20. Significant or chronic renal insufficiency or requires dialytic support.
  21. Hepatic dysfunction.
  22. Absolute neutrophil count <1500 mm3 at screening.
  23. Hemoglobin concentration <9 g/dL at screening.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02700529

Contacts
Contact: Erica McCluskey 650-272-6138 emccluskey@eigerbio.com

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Leslie Jacome-Roche    650-723-1396    lesroche@stanford.edu   
United States, Florida
Orlando Health, Inc. Recruiting
Orlando, Florida, United States, 32806
Contact: Jennifer Quintiliani    321-843-2026    Jennifer.quintiliani@orlandohealth.com   
United States, Ohio
The Ohio State University Wexner Medical Center James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Filiz Muharrem    614-366-5844    filiz.muharrem@osumc.edu   
Australia, New South Wales
Macquarie University Hospital (MUH) Recruiting
Macquarie University, New South Wales, Australia, 2109
Contact: Louise Koelmeyer    +61 2 9850 2358    louise.koelmeyer@mq.edu.au   
Sponsors and Collaborators
Eiger BioPharmaceuticals
  More Information

Publications:
Responsible Party: Eiger BioPharmaceuticals
ClinicalTrials.gov Identifier: NCT02700529     History of Changes
Other Study ID Numbers: EIG-UBX-003
Study First Received: February 26, 2016
Last Updated: March 2, 2017

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases
Ubenimex
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

ClinicalTrials.gov processed this record on May 24, 2017