NCT05203835

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphedema of Upper Arm

Interventions

Type	Name	Description
DRUG	Acebilustat	By mouth, once a day, 100 mg capsule
DRUG	Placebo	Placebo to match acebilustat by mouth, once a day

Timeline

• Start date: 2022-07-27
• Primary completion: 2025-10-21
• Completion: 2026-03-31
• First posted: 2022-01-24
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study