Trial · NCT02700529

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

NCT02700529, Phase 2, Completed, Eiger BioPharmaceuticals; results first posted 2023-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA). Trials, record NCT02700529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02700529

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)
NCT number: NCT02700529
Status: Completed
Phases: Phase 2
Enrollment: 54 participants, actual
Lead sponsor: Eiger BioPharmaceuticals
Conditions: Lymphedema
Interventions: ubenimex, placebo
First posted: 2016-03-07
Last updated: 2023-01-18
Results first posted: 2023-01-18

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Skin Thickness of the Calf of the Most Affected Leg, Measured by Skinfold Calipers	Baseline through Week 24	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).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Skin Thickness of the Calf of the Most Affected Leg, Measured by Skinfold Calipers	Baseline through Week 24	ST-ITT population (patients with skin thickness \>/= 10 mm at baseline) which comprised of 36 patients (16 ubenimex, 20 placebo)	mm	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Skin Thickness of the Calf of the Most Affected Leg, Measured by Skinfold Calipers	Ubenimex		-6.83	Standard Error 1.913	mm
Change in Skin Thickness of the Calf of the Most Affected Leg, Measured by Skinfold Calipers	Placebo		-7.75	Standard Error 1.657	mm

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ubenimex	27
Overall Study	STARTED	Placebo	27
Overall Study	COMPLETED	Ubenimex	26
Overall Study	COMPLETED	Placebo	27
Overall Study	NOT COMPLETED	Ubenimex	1
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Ubenimex	4	27
other	Headache	Nervous system disorders	Placebo	4	27
other	Feeling abnormal	Nervous system disorders	Ubenimex	3	27
other	Feeling abnormal	Nervous system disorders	Placebo	0	27
other	Viral upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Ubenimex	3	27
other	Viral upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Placebo	0	27
other	vomiting	Gastrointestinal disorders	Ubenimex	3	27
other	vomiting	Gastrointestinal disorders	Placebo	0	27
serious	Supraventricular tachycardia /	Cardiac disorders	Ubenimex	1	27
serious	Supraventricular tachycardia /	Cardiac disorders	Placebo	0	27

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ubenimex	0	27
Total, all-cause mortality	Placebo	0	27
Total, other adverse events	Ubenimex	13	27
Total, other adverse events	Placebo	4	27
Total, serious adverse events	Ubenimex	1	27
Total, serious adverse events	Placebo	1	27

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
1846352	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ubenimex vs Placebo: deaths from any cause	Trial comparisons
Ubenimex vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02700529

GET https://conductscience.org/api/trials/v1/NCT02700529/registered

API reference For AI assistants