Trial Outcomes & Findings for Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA) (NCT NCT02700529)
NCT ID: NCT02700529
Last Updated: 2023-01-18
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Baseline through Week 24
Results posted on
2023-01-18
Participant Flow
Participant milestones
| Measure |
Ubenimex
ubenimex capsules 150 mg three times a day (TID), administered orally for a total of 24 weeks.
ubenimex
|
Placebo
matched placebo capsules TID, administered orally for a total of 24 weeks
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)
Baseline characteristics by cohort
| Measure |
Ubenimex
n=27 Participants
ubenimex capsules 150 mg three times a day (TID), administered orally for a total of 24 weeks.
ubenimex
|
Placebo
n=27 Participants
matched placebo capsules TID, administered orally for a total of 24 weeks
placebo
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Type of Lymphedema
Secondary Lymphedema
|
21 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Age, Continuous
|
55.0 years
n=93 Participants
|
53.4 years
n=4 Participants
|
54.2 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Type of Lymphedema
Primary Lymphedema
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 24Population: ST-ITT population (patients with skin thickness \>/= 10 mm at baseline) which comprised of 36 patients (16 ubenimex, 20 placebo)
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).
Outcome measures
| Measure |
Ubenimex
n=16 Participants
ubenimex capsules 150 mg three times a day (TID), administered orally for a total of 24 weeks.
ubenimex
|
Placebo
n=20 Participants
matched placebo capsules TID, administered orally for a total of 24 weeks
placebo
|
|---|---|---|
|
Change in Skin Thickness of the Calf of the Most Affected Leg, Measured by Skinfold Calipers
|
-6.83 mm
Standard Error 1.913
|
-7.75 mm
Standard Error 1.657
|
Adverse Events
Ubenimex
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ubenimex
n=27 participants at risk
ubenimex capsules 150 mg three TID, administered orally for a total of 24 weeks.
ubenimex
|
Placebo
n=27 participants at risk
matched placebo capsules TID, administered orally for a total of 24 weeks
placebo
|
|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia /
|
3.7%
1/27 • 7 months
|
0.00%
0/27 • 7 months
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.00%
0/27 • 7 months
|
3.7%
1/27 • 7 months
|
Other adverse events
| Measure |
Ubenimex
n=27 participants at risk
ubenimex capsules 150 mg three TID, administered orally for a total of 24 weeks.
ubenimex
|
Placebo
n=27 participants at risk
matched placebo capsules TID, administered orally for a total of 24 weeks
placebo
|
|---|---|---|
|
Nervous system disorders
Headache
|
14.8%
4/27 • 7 months
|
14.8%
4/27 • 7 months
|
|
Nervous system disorders
Feeling abnormal
|
11.1%
3/27 • 7 months
|
0.00%
0/27 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
11.1%
3/27 • 7 months
|
0.00%
0/27 • 7 months
|
|
Gastrointestinal disorders
vomiting
|
11.1%
3/27 • 7 months
|
0.00%
0/27 • 7 months
|
Additional Information
Senior VP, Clinical Development
Eiger BioPharmaceuticals, Inc.
Phone: 1-650-618-1621
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place