Could a daily pill reduce arm swelling? new trial tests acebilustat
NCT ID NCT05203835
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a daily pill called acebilustat in 40 adults with long-term arm lymphedema (stage 2, lasting over 6 months). Participants took either the drug or a placebo for 9 months, with the first 3 months on placebo for all. The main goal was to see if the drug reduces skin thickness in the affected arm. Researchers also measured changes in arm volume and structure using ultrasound.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Acebilustat (a daily oral capsule)
- What this could lead to
- If it works, this could point toward a new daily pill to reduce arm swelling and skin thickness in people with lymphedema.
- What could go wrong
- This is a small, early-phase trial with only 40 people. The drug may not reduce swelling better than placebo, and long-term safety is not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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40 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 that confirms the presence of lymphedema in the affected limb OR, at screening, an affected: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 node transfer, lymphaticovenous anastomosis) or debulking surgical intervention, at least one 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 consent document. * . 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. Exclusion Criteria: * Concurrent participation in a clinical trial of any other investigational drug or therapy * 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 of lymphedema (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 or interleukin 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 the investigator, precludes full participation in the study. * Any current use of statin drugs. The use of any statin drug should be discontinued at least 2 weeks prior to the trial enrollment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stanford University
Palo Alto, California, 94305, United States
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Other studies related to the condition(s) this trial covers.