Trial of Acebilustat for the Treatment of Upper Arm Lymphedema

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 thatconfirms the presence of lymphedema in the affected limb OR, at screening, anaffected: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 nodetransfer, lymphaticovenous anastomosis) or debulking surgical intervention, at leastone 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 consentdocument.

• . If the possibility of conception exits, agrees to use a medically acceptablemethod of contraception (both male and female) from the signing of the informedconsent form through the entire study period; men or women who are surgicallysterile (> 6 months after surgery) or women who have been postmenopausal for atleast 1 year are not considered to be of childbearing potential.

Exclusion Criteria:

• Concurrent participation in a clinical trial of any other investigational drug ortherapy

• 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 oflymphedema (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 orinterleukin 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 theinvestigator, precludes full participation in the study.

• Any current use of statin drugs. The use of any statin drug should be discontinuedat least 2 weeks prior to the trial enrollment