Acebilustat for the Treatment of Arm Lymphedema

Inclusion Criteria

• Upper extremity lymphedema
• International Society of Lymphology (ISL) stage II
• Unilateral
• Duration >= 6 months
• At screening, affected:unaffected limb volume ratio >= 1.2
• Completion of complete decongestive lymphedema therapy (CDT) at least 8 weeks prior to screening
• Age 18-75 inclusive
• Eastern Cooperative Oncology Group (ECOG) status 0-2
• Consistent use of an appropriately sized compression garment for daytime use
• Willingness to maintain a stable regimen of self care from screening to end of study
• Willing and able to comply with all study procedures
• 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
• If the possibility of conception exits, agrees to use a medically acceptable method of contraception (both male and female) from the signing of the informed consent form through the entire study period; men or women who are surgically sterile (> 6 months after surgery) or women who have been postmenopausal for at least 1 year are not considered to be of childbearing potential
• Has received Covid-19 vaccine (Pfizer, Moderna, or Johnson & Johnson)
• Ability to understand and the willingness to personally sign the written Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria

• Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month of screening or 5 times the drugs half life, whichever is longer
• Any other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis
• Other medical conditions that could result in symptoms overlapping those of lymphedema in the affected limb (eg, pain, swelling, decreased range of motion)
• History of clotting disorder (hypercoagulable state)
• Chronic (persistent) infection in the affected limb
• Other infection (unrelated to lymphedema) within 1 month prior to screening
• Current evidence of active malignancy or history of malignancy within the past 2 years, except for non melanoma skin cancer or cervical cancer in-situ, treated with curative intent; if breast cancer-related, stage IIIB or greater
• Current receiving chemotherapy or radiation therapy; if applicable, cancer treatment completed > 2 years prior to enrollment
• Chronic renal insufficiency, defined as serum creatinine > 2.5 mg/dl or an estimated glomerular filtration rate (eGFR) < 30 mL/min at screening, or requires dialytic support
• Alanine transaminase (ALT) or aspartate transaminase (AST) levels 3 times the upper limit of the normal range (ULN) at screening
• Bilirubin level > 2 times ULN at screening
• Absolute neutrophil count (ANC) < 1500/mm^3 at screening
• Hemoglobin concentration < 9 g/dL at screening
• Pregnancy or nursing
• Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
• Known allergy to any of the chemical components in the investigational agent
• Any current use of non-steroidal anti-inflammatory drug (NSAID), eg, ibuprofen, ketoprofen or prior therapeutic use of ketoprofen
• Any current use of immunosuppressive or immunomodulatory drugs, eg, immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers or leukotriene pathway inhibitor (zileuton) or leukotriene receptor antagonist (montelukast)
• Personal or family history of prolonged QT syndrome; QTcF interval > 430 msecs (males) or > 450 msecs (females) or deemed clinically abnormal by the principal investigator (PI)
• Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study