An Open-Label, Single-Arm, 2-Year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Subjects with Stargardt Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623001328662

Enrollment

Registered

2023-12-19

Start date

2023-11-14

Completion date

2024-04-22

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Since Tinlarebant has not yet been approved, the purpose of this study is to continuously provide Tinlarebant to patients who have completed the 24 months of treatment with Tinlarebant in the previous study (i.e., LBS-008-CT02) with no safety issues.

Interventions

Oral Tinlarebant tablet (5mg) once daily for 24 months. Subjects will record the administation of the study drug via daily patient diary.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

12 Years to 20 Years

Healthy volunteers

Inclusion criteria

Subject has completed treatment in LBS-008-CT02 trial and has also completed the tests and assessments required end-of-treatment visit.

Exclusion criteria

1. Ocular surgery in the study eye in the previous 3 months. 2. Use of prescription medications such as Isotretinoin (13-cis-retinoic acid) or other retinol modulators or derivatives 3. Use of any known drugs or supplements that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes

Outcome results