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AVTX-803 for Leukocyte Adhesion Deficiency Type II

This study is testing a drug called AVTX-803 (L-Fucose) for people with Leukocyte Adhesion Deficiency Type II (LAD II). LAD II is a rare genetic condition that can cause frequent or severe infections. Researchers want to see how safe and effective AVTX-803 is. They will measure how the drug affects a specific marker on white blood cells called Sialyl-Lewis X antigen over 56 and 112 days. To join, you must be between 6 months and 75 years old, have a confirmed diagnosis of LAD II, and a history of recurrent infections. The study plans to enroll 4 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 4 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for the study are taken at Day 56 and Day 112, indicating follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05462587

A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients With Leukocyte Adhesion Deficiency Type II

Recruiting
PHASE3Ages 6–75InterventionalTreatment
AUG Therapeutics
~4 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:AVTX-803 (L-Fucose)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effect of AVTX-803 on the percent of leukocytes expressing Sialyl-Lewis X antigen
Measured over Change from Baseline at Day 56, Change from Baseline at Day 112

Conditions

Leukocyte Adhesion Deficiency

Explore related trials

Leukocyte Adhesion Deficiency Type 2SLC35C1 Gene

NCT05462587

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Rochester, Minnesotano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • David Deyle, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Jennifer Lin
[email protected]
3052833827
Email the study team

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Eligibility criteria

Inclusion

Subject must be between 6 months and 75 years old
Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)
Subject has a documented history of Lewis antigen deficiency
Subject has a history of recurrent infections, opportunistic infections or infections that did not respond well to standard of care treatment
Subject or parent (for subjects under legal age for consent) has provided written informed consent for this study. Additionally, written informed assent has been provided, as appropriate, for minors of older age, per local institutional review board (IRB)/ethics committee (EC) policy and requirements
Subject is willing and able to comply with the protocol
Women of childbearing potential (WOCBP) meeting the criteria below:
Male subjects must agree to use an acceptable double-barrier method of contraception with their partner as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug.

Exclusion

Subject has severe anemia defined as hemoglobin \<8.0 g/dL (\<4.9 mmol/L)
Subject has impaired renal function as defined by an eGFR \<90 mL/min
Subject has a total absence of fucosylation on red blood cells and the presence of anti-H antigen
Subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product
In the investigator's opinion, subject has a history of failure to respond to fucose at adequate dosing
In the investigator's opinion, subject is not able or not willing to comply with the study requirements.
Subject is pregnant

What this trial measures

  • Effect of AVTX-803 on the percent of leukocytes expressing Sialyl-Lewis X antigenChange from Baseline at Day 56, Change from Baseline at Day 112

    To assess the effect of AVTX-803 in subjects with leukocyte adhesion deficiency Type II (LAD II) by evaluating Sialyl-Lewis X on leukocytes as a percentage present at the end of each 8 week treatment period.