Trials / Recruiting
RecruitingNCT07419334
Study of ALK-001 on the Progression of Stargardt Disease
A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK 001) on the Progression of Stargardt Disease (STGD)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- Alkeus Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 8 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the efficacy and safety of investigational study drug ALK-001 in participants 8 to 45 years of age, inclusive, with symptoms and signs of autosomal recessive Stargardt disease (STGD)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALK-001 | Daily oral administration for 24 months |
| DRUG | Placebo | Daily oral administration for 24 months |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2029-10-01
- Completion
- 2030-12-01
- First posted
- 2026-02-19
- Last updated
- 2026-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07419334. Inclusion in this directory is not an endorsement.