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Trial of Acebilustat for the Treatment of Upper Arm Lymphedema (HEAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05203835
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : August 8, 2022
Sponsor:
Collaborator:
Celltaxis LLC
Information provided by (Responsible Party):
Stanley Rockson, Stanford University

Study Description
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Brief Summary:
This study is designed to investigate the response of unilateral upper extremity (arm) lymphedema, during pharmacologic treatment of lymphedema with oral placebo and oral acebilustat. Participants will receive "study drug" (Acebilustat or placebo), for 9 months. For 3 of these months, the participant will receive placebo; for 6 of these months, the participant will receive active ingredient, acebilustat. The study is blinded which means that the participant will not be told which study pill they are taking.

Condition or disease Intervention/treatment Phase
Lymphedema of Upper Arm Drug: Acebilustat Drug: Placebo Phase 2

Detailed Description:
To enter this study, participants will have to meet requirements that will be evaluated during screening, Visit 1. If eligible, and if they choose to continue, Visit 2, treatment start, will take place 2-7 days later. Study visits are every (approximately) 90 days. Physical exam, including limb measurements and skin measurements (with tape measure and dermal ultrasound) are performed. Phlebotomy for research samples and clinical labs will be performed at study start and end of study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Placebo-Controlled Trial of Acebilustat (CTX-4430) for the Treatment of Human Upper Extremity Lymphedema
Actual Study Start Date : July 27, 2022
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Placebo and acebilustat
Participants will take acebilustat and placebo over a period of 9 months.
 Drug: Acebilustat
By mouth, once a day, 100 mg capsule

Drug: Placebo
Placebo to match acebilustat by mouth, once a day


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in ultrasonographic measurement of dermal thickness in the affected upper extremity [ Time Frame: Baseline through week 36 ]
    Dermal thickness will be derived from an ultrasonographic examination of the skin of the forearm using a Terason 3200T device.


Secondary Outcome Measures :
  1. Change from baseline in caliper measurement of dermal thickness in the affected upper extremity [ Time Frame: Baseline through week 36 ]
    Dermal thickness will be derived from a caliper measurement of the skin of the forearm.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Upper arm lymphedema, single arm, stage 2, greater than 6 months duration
  • Male or female.
  • Ages 18-75.
  • If a potential participant has undergone surgical treatment, lymph node transfer, suction-assisted lipectomy, or lymphatico-venous anastamosis, at least one year must have elapsed prior to screening.
  • 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.
  • 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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05203835


Contacts
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Contact: Marissa Dobry 650-725-7571 mdobry@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Leslie Jacome-Roche, RN    650-723-1396      
Sub-Investigator: Mark Nicolls, MD         
Sub-Investigator: Wen Tian, PhD         
Sub-Investigator: Xinguo Jiang, MD         
Sponsors and Collaborators
Stanford University
Celltaxis LLC
Investigators
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Principal Investigator: Stanley Rockson, MD Stanford University
More Information
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Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT05203835    
Other Study ID Numbers: 62051
First Posted: January 24, 2022    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases