Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Sjogren-Larsson Syndrome, sponsored by University of Nebraska.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants are required to report any adverse events as they arise and will be contacted weekly for information regarding adverse events. Physical examinations with vital signs will be done monthly.
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 |
What the registry record for NCT05443685 still lists
NCT05443685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05443685's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI