Trial of Acebilustat for the Treatment of Upper Arm Lymphedema

• Status: Not yet recruiting
• Trial end date: 2025-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Celltaxis LLC

Criteria

Inclusion Criteria:

• Upper arm lymphedema, single arm, stage 2, greater than 6 months duration

• Male or female.

• Ages 18-75.

• If a potential participant has undergone surgical treatment, lymph node transfer, suction-assisted lipectomy, or lymphatico-venous anastamosis, at least one year must have elapsed prior to screening.

• 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.

• 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.

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.

• Any current use of immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers) or leukotriene pathway inhibitor (zileuton), leukotriene receptor antagonist (e.g montelukast).

• Personal or family history of prolonged QT syndrome

• Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.