40 Participants Needed

Acebilustat for Arm Lymphedema

(HEAL Trial)

LR
MD
SH
MN
HF
OA
Overseen ByOsama Alnahar
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. Specifically, you must stop using non-steroidal anti-inflammatory drugs (like ibuprofen), immunosuppressive drugs, leukotriene pathway inhibitors, and statin drugs. Statin drugs should be discontinued at least 2 weeks before joining the trial.

How does the drug Acebilustat differ from other treatments for arm lymphedema?

Acebilustat is unique because it is being investigated specifically for arm lymphedema, a condition with limited standard treatment options, and it may offer a novel approach by targeting specific pathways involved in inflammation and fluid retention.12345

Research Team

SR

Stanley Rockson, MD

Principal Investigator

Stanford University

Eligibility Criteria

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.

Inclusion Criteria

Ability to understand and sign informed consent document
I am willing to keep a consistent self-care routine.
I am between 18 and 75 years old.
See 7 more

Exclusion Criteria

Any reason precluding full participation in the study
Substance abuse within 6 months prior to screening
I or my family have a history of prolonged QT syndrome.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-7 days
1 visit (in-person)

Treatment

Participants receive oral placebo and acebilustat for 9 months, with 3 months on placebo and 6 months on acebilustat

36 weeks
4 visits (in-person, approximately every 90 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Acebilustat
  • Placebo
Trial OverviewThe 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).
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Placebo and acebilustatExperimental Treatment2 Interventions
Participants will take acebilustat and placebo over a period of 9 months.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Celltaxis LLC

Collaborator

Trials
1
Recruited
40+

Findings from Research

Icatibant is a safe and effective treatment for acute attacks of hereditary angioedema in adults, with clinical evidence supporting its use and only 10% of patients needing a second dose.
The most common side effects are mild and localized, such as pain and swelling at the injection site, and no serious adverse reactions have been reported, making it a favorable option for self-administration.
An evidence-based review of the potential role of icatibant in the treatment of acute attacks in hereditary angioedema type I and II.Floccard, B., Hautin, E., Bouillet, L., et al.[2021]
In cases of acute angioedema that do not respond to standard antihistamine treatments, such as when bradykinin is involved instead of histamine, alternative therapies like the beta2 receptor antagonist icatibant may provide relief, as demonstrated in a reported case where the patient experienced improvement within 20 minutes.
Although icatibant is officially approved only for hereditary angioedema, its off-label use in other types of angioedema can be justified in life-threatening situations, highlighting the need for flexibility in treatment options when standard therapies fail.
Treatment with icatibant in the management of drug induced angioedema.Bertazzoni, G., Bresciani, E., Cipollone, L., et al.[2018]
A 78-year-old woman with severe angioedema caused by ACE inhibitors did not respond to standard treatments but was successfully treated with icatibant, a drug typically used for hereditary angioedema.
This case suggests that icatibant may be effective for ACE-i induced angioedema due to its mechanism of blocking bradykinin B2 receptors, highlighting the need for further randomized controlled trials to confirm its efficacy in this context.
[Icatibant is a new treatment option in life-threatening angioedema triggered by angiotensin-converting enzyme inhibitor].Fast, S., Henningsen, E., Bygum, A.[2011]

References

An evidence-based review of the potential role of icatibant in the treatment of acute attacks in hereditary angioedema type I and II. [2021]
Treatment with icatibant in the management of drug induced angioedema. [2018]
[Icatibant is a new treatment option in life-threatening angioedema triggered by angiotensin-converting enzyme inhibitor]. [2011]
Real-world off-label use of icatibant for acute management of non-hereditary angioedema. [2021]
The Angiotensin-Converting-Enzyme-Induced Angioedema. [2017]