Swelling Of The Arm > Acebilustat

Acebilustat for Arm Lymphedema (HEAL Trial)

Recruiting in Palo Alto (17 mi)

Overseen By Stanley Rockson, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Stanford University

No Placebo Group

Prior Safety Data

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.

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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

I am between 18 and 75 years old.

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

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

Exclusion Criteria

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

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

I am currently using NSAIDs or have used ketoprofen before.

I have a history of blood clots.

I have chronic kidney disease.

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

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

Participant Groups

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).

Group I: Placebo and acebilustat Experimental Treatment 2 Interventions

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

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Stanford University Palo Alto, CA

Who is running the clinical trial?

Stanford University Lead Sponsor

Celltaxis LLC Collaborator

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

An evidence-based review of the potential role of icatibant in the treatment of acute attacks in hereditary angioedema type I and II. [2021] Icatibant, a first-in-class B2 bradykinin receptor antagonist, appears to have a favorable efficacy and safety profile for the treatment of acute attacks of hereditary angioedema in adults.

2. Italy pubmed.ncbi.nlm.nih.gov

Treatment with icatibant in the management of drug induced angioedema. [2018] Acute, drug-induced angioedema may not respond to standard therapies, because the pathogenetic mechanism that induces the pathology is not always mediated by histamine but, in certain instances, by bradykinin. A case of angioedema is reported here, in which allergic etiology was excluded by the non-response to antihistamines. Considering the clinical history (repeated use of drugs) and the ineffectiveness of standard therapy, it was decided to administer a beta2 receptor antagonist, icatibant. After 20 minutes, the patient reported a subjective improvement. The only form of angioedema for which this type of medication is licensed is the hereditary deficiency of C1 inhibitor. The use of icatibant for the treatment of other types of angioedema (which can also be life-saving if the airway is involved) is off label. The off-label use of a drug is allowed in the absence of a viable alternative therapy, if there is scientific evidence in the literature and if the prescriber takes responsibility. The case here reported draws attention to this therapeutic problem and underlines the fact that a life-threatening emergency can justify the use of icatibant.

3. Denmark pubmed.ncbi.nlm.nih.gov

[Icatibant is a new treatment option in life-threatening angioedema triggered by angiotensin-converting enzyme inhibitor]. [2011] A 78 year-old woman with life-threatening angiotensin-converting enzyme inhibitor (ACE-i) induced angioedema was unresponsive to conventional treatment with corticosteroids, antihistamines and epinephrine. She was successfully treated with icatibant licensed for treatment of hereditary angioedema knowing that both conditions involve bradykinin induced activation of bradykinin B2 receptors. Randomised, controlled trials are warranted to document the efficacy of icatibant in ACE-i angioedema.

4. Australia pubmed.ncbi.nlm.nih.gov

Real-world off-label use of icatibant for acute management of non-hereditary angioedema. [2021] We retrospectively examined the indications and efficacy of off-label use of the bradykinin B2 receptor antagonist icatibant. The clinical heterogeneity, variability of response to icatibant and lack of efficacy of adrenaline described in this audit highlights both the need for biomarkers that can rapidly distinguish between histaminergic and non-histaminergic angioedema, and for guidelines to improve the utility of icatibant in the non-hereditary angioedema setting.

5. United States pubmed.ncbi.nlm.nih.gov

The Angiotensin-Converting-Enzyme-Induced Angioedema. [2017] The bradykinin B2 receptor antagonist icatibant is effective in angiotensin-converting enzyme inhibitor-induced angioedema. The drug is not approved officially for this indication and has to be administered in an emergency situation off-label. Corticosteroids or antihistamines do not seem to work in this condition. The effectiveness of C1-esterase-inhibitor in angiotensin-converting enzyme-induced angioedema must be verified in a double-blind study.