What side effects are associated with this type of intervention?

Common treatments for lymphedema include Complete Decongestive Therapy (CDT), compression garments, and intermittent pneumatic compression (IPC). CDT can cause skin irritation and discomfort due to bandaging. Compression garments may lead to skin breakdown and discomfort if not properly fitted. IPC is generally well-tolerated but can cause temporary discomfort during use. For treatments similar to Acebilustat, which targets leukotriene pathways, side effects may include upper respiratory tract infections, headache, and injection site pain, as seen with other leukotriene inhibitors like lebrikizumab.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically for the treatment of lymphedema. Management typically involves physical therapies such as compression garments, manual lymphatic drainage, and exercise. Acebilustat, which is being studied for its potential to reduce inflammation by inhibiting leukotriene A4 hydrolase, represents a novel approach in pharmacologic treatment for lymphedema. Other anti-inflammatory drugs and treatments targeting similar pathways are still under investigation.

What other types of research exist?

Promising novel alternatives to Acebilustat for lymphedema treatment in 2024 include biologics targeting specific inflammatory pathways, such as anti-IL-22 antibodies (e.g., fezakinumab) and IL-4/IL-13 dual blockade agents (e.g., dupilumab). These therapies have shown efficacy in reducing inflammation in other conditions and may offer potential benefits for lymphedema patients.

← Back to Search

Anti-inflammatory

Acebilustat for Arm Lymphedema (HEAL Trial)

Phase 2

Recruiting

Led By Stanley Rockson, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female aged 18-75

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

Must not have

Personal or family history of prolonged QT syndrome

Chronic infection in affected limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 36

Summary

This trial tests a drug called acebilustat to see if it can help people with swelling in one arm (unilateral upper extremity lymphedema). Participants will take the drug for several months. The goal is to see if acebilustat can reduce inflammation and fluid buildup in the affected arm.

Who is the study for?

This trial is for adults aged 18-75 with stage 2 upper arm lymphedema lasting over 6 months. Participants must have completed lymphedema therapy at least 8 weeks prior, be vaccinated against COVID-19, and use compression garments. They can't join if they have clotting disorders, chronic infections in the limb, kidney or liver disease, are pregnant/nursing, have a history of substance abuse within the last six months or are on certain medications like statins.

What is being tested?

The study tests Acebilustat's effectiveness for treating unilateral upper extremity lymphedema compared to a placebo. Over nine months, participants will unknowingly receive either Acebilustat or a placebo for different durations (placebo for three months and Acebilustat for six).

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include typical drug reactions such as gastrointestinal issues, allergic responses or skin rashes. Since it's an oral medication being tested against a placebo without active ingredients, some participants might not experience any side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Select...

I have had stage 2 lymphedema in one arm for over 6 months.

Select...

I have received a Covid-19 vaccine (Pfizer, Moderna, or Johnson & Johnson).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I or my family have a history of prolonged QT syndrome.

Select...

I have a long-lasting infection in one of my limbs.

Select...

I am currently using NSAIDs or have used ketoprofen before.

Select...

I have a history of blood clots.

Select...

I have chronic kidney disease.

Select...

I am currently taking drugs that suppress my immune system or affect leukotriene pathways.

Select...

I have a condition that causes sudden swelling in my limbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in ultrasonographic measurement of dermal thickness in the affected upper extremity

Secondary study objectives

Change from baseline in caliper measurement of dermal thickness in the affected upper extremity

Side effects data

From 2023 Phase 2 trial • 120 Patients • NCT04662060

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Acebilustat

Trial Design

1Treatment groups

Experimental Treatment

Group I: Placebo and acebilustatExperimental Treatment2 Interventions

Participants will take acebilustat and placebo over a period of 9 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acebilustat

Not yet FDA approved

Placebo

1995

Completed Phase 3

~2670

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lymphedema include Complete Decongestive Therapy (CDT) and Intermittent Pneumatic Compression (IPC). CDT combines manual lymph drainage, compression bandaging, exercise, and skin care to reduce swelling and improve lymphatic function. IPC uses a device to apply sequential pressure to the limb, promoting lymph fluid movement. These treatments aim to reduce edema and prevent complications. Acebilustat, which inhibits leukotriene A4 hydrolase to reduce inflammation, represents a pharmacologic approach that could complement these therapies by targeting underlying inflammatory processes, potentially offering additional relief for patients.

Long-Term Efficacy of Subcutaneous C1 Inhibitor in Pediatric Patients with Hereditary Angioedema.Efficacy of Treatment of Non-hereditary Angioedema.Isolated oedema of the uvula induced by intense snoring and ACE inhibitor.