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

NCT02700529 | Completed Phase 2 Results

• 1 other identifier: EIG-UBX-003
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• Change in Skin Thickness of the Calf of the Most Affected Leg, Measured by Skinfold Calipers

  Change from baseline to Week 24 in skin thickness of the calf of the most affected leg, measured by skinfold calipers in the Skin-Thickness Intent-to-Treat (ST-ITT) population (patients with skin thickness \>/= 10 mm at baseline) which comprised of 36 patients (16 ubenimex, 20 placebo).

  Baseline through Week 24

Study Arms (2)

ubenimex

EXPERIMENTAL

ubenimex capsules 150 mg three times a day (TID), administered orally for a total of 24 weeks.

Drug: ubenimex

placebo

PLACEBO COMPARATOR

matched placebo capsules TID, administered orally for a total of 24 weeks

Other: placebo

Interventions

ubenimex DRUG

Also known as: UBX

ubenimex

placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.
• 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.

Sponsors & Collaborators

• Eiger BioPharmaceuticals: lead

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

Orlando Health, Inc.

Orlando, Florida, 32806, United States

Location

The Ohio State University Wexner Medical Center James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Macquarie University Hospital (MUH)

Sydney, New South Wales, 2109, Australia

Location

Related Publications (1)

• Orning L, Krivi G, Fitzpatrick FA. Leukotriene A4 hydrolase. Inhibition by bestatin and intrinsic aminopeptidase activity establish its functional resemblance to metallohydrolase enzymes. J Biol Chem. 1991 Jan 25;266(3):1375-8.

  PMID: 1846352 BACKGROUND

MeSH Terms

Conditions

Lymphedema

Interventions

ubenimex

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Senior VP, Clinical Development
• Organization: Eiger BioPharmaceuticals, Inc.

info@eigerbio.com

1-650-618-1621

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 7, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2019
• Last Updated: January 18, 2023
• Results First Posted: January 18, 2023

Record last verified: 2022-12

Locations

AU (1); US (3)