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Study of ALK-001 on the Progression of Stargardt Disease

NCT07419334 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-05-05

No results posted yet for this study

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

DRUG

ALK-001

Daily oral administration for 24 months

DRUG

Placebo

Daily oral administration for 24 months

Sponsors & Collaborators

  • Alkeus Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-10-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07419334 on ClinicalTrials.gov