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Trial of Acebilustat for the Treatment of Upper Arm Lymphedema

A Pilot Placebo-Controlled Trial of Acebilustat (CTX-4430) for the Treatment of Human Upper Extremity Lymphedema

NCT05203835•Stanford University

Summary

This study is designed to investigate the response of unilateral upper extremity (arm) lymphedema, during pharmacologic treatment of lymphedema with oral placebo and oral acebilustat. Participants will receive "study drug" (Acebilustat or placebo), for 9 months. For 3 of these months, the participant will receive placebo; for 6 of these months, the participant will receive active ingredient, acebilustat. The study is blinded which means that the participant will not be told which study pill they are taking.

Detailed Description

To enter this study, participants will have to meet requirements that will be evaluated during screening, Visit 1. If eligible, and if they choose to continue, Visit 2, treatment start, will take place 2-7 days later. Study visits are every (approximately) 90 days. Physical exam, including limb measurements and skin measurements (with tape measure and dermal ultrasound) are performed. Phlebotomy for research samples and clinical labs will be performed at study start and end of study.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Upper arm lymphedema, single arm, stage 2, greater than 6 months duration
•Male or female.
•Ages 18-75.
•Prior imaging by lymphoscintigraphy or magnetic resonance lymphangiography that confirms the presence of lymphedema in the affected limb OR, at screening, an affected:unaffected limb volume ratio of ≥1.1 with significant history of lymphedema
•Consistent use of an appropriately sized compression garment for daytime use.
•Willing to maintain a stable regimen of self-care from screening to end-of-study.
•If a potential participant has undergone prior microvascular (vascular lymph node transfer, lymphaticovenous anastomosis) or debulking surgical intervention, at least one year must have elapsed prior to screening AND, at screening, an affected: unaffected limb volume ratio of ≥1.1.
•Lymphedema therapy must be completed at least 8 weeks prior to screening.
•Has received Covid-19 vaccine (Pfizer, Moderna or Johnson \& Johnson)
•Ability to understand and the willingness to sign a written informed consent document.
+1 more criteria

Exclusion Criteria

•Concurrent participation in a clinical trial of any other investigational drug or therapy
•Other medical condition that could lead to acute limb edema (e.g. acute blood clot) or other medical condition that could result in symptoms overlapping those of lymphedema (e.g. frozen shoulder).
•History of clotting disorder.
•Chronic (persistent) infection in the affected limb.
•Active cancer treatment or history of cancer treatment within the past 2 years, except for non-melanoma skin cancer or cervical cancer in-situ.
•Chronic kidney disease
•Liver disease
•Pregnancy or nursing.
•Substance abuse (e.g., alcohol or drug abuse) within 6 months prior to screening.
•Any current use of non-steroidal anti-inflammatory drug (NSAID), e.g. ibuprofen, ketoprofen) or prior therapeutic use of ketoprofen.
+4 more criteria

Locations (1)

Stanford University

Palo Alto, California, United States

Key Dates

Start Date

July 27, 2022

Primary Completion Date

October 21, 2025

Completion Date

March 31, 2026

Last Updated

November 25, 2025

Enrollment

ESTIMATED participants

Conditions

Lymphedema of Upper Arm

Interventions

Acebilustat

DRUG

Placebo

DRUG

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COMPLETEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Acebilustat for the Treatment of Upper Arm Lymphedema

Inclusion Criteria

Exclusion Criteria

The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema

Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity

Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase

Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema.

Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema