Recruiting
Phase 3

AVTX-803

Sponsor:

AUG Therapeutics

Code:

NCT05754450

Conditions

Leukocyte Adhesion Deficiency

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

AVTX-803

Study Details

Brief summary:

The primary objective of this extension study is to assess the long-term safety and efficacy of AVTX-803 in subjects with LAD II (SLC35C1-CDG).

Conditions

Leukocyte Adhesion Deficiency

Study ID

NCT05754450

Start date

Apr 10, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject must have completed protocol AVTX-803-LAD-301
  • Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)

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 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

Study Design

Enrollment

2 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AVTX-803

AVTX-803 at a dose specified by the investigator up to 5 times a day not to exceed 1700 mg/kg/day

Interventions

AVTX-803

L-fucose crystalline powder

Primary outcome measure

  • Incidence of treatment emergent adverse events reported during the study attributable to AVTX-803. [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts and Locations

Central contacts

Jennifer Lin

3052833827huiyil@Augtx.com

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

AUG Therapeutics

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AUG Therapeutics on 2026-05-01.