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NCT05443685 · ClinicalTrials.gov registry record · Phase 1
ADX-629 Therapy for Sjogren-Larsson Syndrome
A Phase 1 study of Sjogren-Larsson Syndrome, sponsored by University of Nebraska.
- Active
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT05443685 is a Phase 1 study of Sjogren-Larsson Syndrome that is active but no longer recruiting, run by University of Nebraska. The registered enrollment target is 8 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05443685, a Phase 1 study of Sjogren-Larsson Syndrome, is active but no longer recruiting, sponsored by University of Nebraska.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study will determine whether orally administered ADX-629 is safe and has biochemical efficacy in participants with Sjögren-Larsson syndrome (SLS), a rare inherited disorder of fatty aldehyde metabolism The disease is caused by bi-allelic mutations in ALDH3A2, which results in deficient activity of fatty aldehyde dehydrogenase (FALDH) and leads to the build-up of harmful long-chain (C16-C20) aldehydes and alcohols. Accumulation of these lipids and their metabolic products in skin, brain and eyes is responsible for the symptoms, which persist lifelong. ADX-629 is an aldehyde trapping agent that is expected to eliminate fatty aldehydes and negate aldehyde toxicity, improve the biochemical abnormalities and have clinical efficacy for SLS. The primary objective of this clinical protocol is to determine whether ADX-629 is safe and tolerable for use in SLS subjects. The secondary objective is to determine the efficacy of ADX-629 in reversing the biochemical abnormalities in SLS. Exploratory objectives are to evaluate the short-term clinical effects of ADX-629 on neurologic, cutaneous and ophthalmologic disease in SLS. Participants will be treated with ADX-629 for 12 weeks and monitored for safety and biochemical efficacy.
Conditions Studied
Interventions
- DRUG ADX-629
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-01-02 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05443685
The ClinicalTrials.gov registry entry for NCT05443685 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sjogren-Larsson Syndrome appearing as the primary indexed condition, and to 1 intervention - of which ADX-629 is the first listed.
NCT05443685 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT05443685 about?
NCT05443685 is a clinical study titled "ADX-629 Therapy for Sjogren-Larsson Syndrome". This research study will determine whether orally administered ADX-629 is safe and has biochemical efficacy in participants with Sjögren-Larsson syndrome (SLS), a rare inherited disorder of fatty aldehyde metabolism The disease is caused by bi-allelic mutations in ALDH3A2, which results in deficient...
What is the current status of trial NCT05443685?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2023-01-02. Estimated completion is 2027-03.
What conditions does trial NCT05443685 study?
This clinical trial studies the following conditions: Sjogren-Larsson Syndrome.
What interventions are being tested in trial NCT05443685?
The interventions under investigation include: ADX-629 (DRUG).
Who is sponsoring clinical trial NCT05443685?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05443685 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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