NCT05462587 · AUG Therapeutics
A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients With Leukocyte Adhesion Deficiency Type II
What this study is about
The primary objective of this study is to evaluate the effectiveness and safety of AVTX-803 compared to withdrawal in patients with Leukocyte Adhesion Deficiency, Type II (LAD II).
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The primary objective of this study is to evaluate the efficacy and safety of AVTX-803 compared to withdrawal in patients with Leukocyte Adhesion Deficiency, Type II (LAD II).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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:
- Non-lactating and has a negative pregnancy test at screening -AND-
- Uses an acceptable double-barrier method of contraception as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug.
- 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 criteria
- 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
Where
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations