A Phase 3, Randomized, Double-blind, Two-period, Crossover, Withdrawal Study to Assess the Efficacy and Safety of AVTX-803 in Subjects With Leukocyte Adhesion Deficiency Type II (LAD II)
AUG Therapeutics
Summary
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).
Eligibility
- Age range
- 0–75 years
- Sex
- All
- Healthy volunteers
- No
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 bo…
Interventions
- DrugAVTX-803 (L-Fucose)
L-fucose crystalline powder
Location
- Mayo ClinicRochester, Minnesota