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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
AUG Therapeutics
Study ID
NCT05462587
Phase
PHASE3
Status
Recruiting
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Conditions

  • Leukocyte Adhesion Deficiency

Eligibility Criteria

Sex
ALL
Age
6 Months - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AVTX-803 (L-Fucose) — DRUG
    L-fucose crystalline powder

Study Details

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).

Key Dates

Start date
Jul 28, 2022
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
4 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: AVTX-803
    Approximately 4 subjects will receive AVTX-803 at a dose specified by the investigator up to 5 times a day not to exceed 1700 mg/kg/day for 8 weeks.
  • No Intervention: Withdrawal
    Subject will be in withdrawal for 8 weeks.

Primary Outcome Measure

Effect of AVTX-803 on the percent of leukocytes expressing Sialyl-Lewis X antigen [ Time Frame: Change from Baseline at Day 56, Change from Baseline at Day 112 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Queenie Tan, MD PhD

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By research site
Mayo Clinic· Rochester, MN

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