A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2028-01-31

Brief Summary

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The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease

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Detailed Description

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This study will be comprised of a Phase 1b part conducted in Japan and a Phase 2/3 part. The Phase 1b part of the study will be open-label and will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of daily doses of 5 mg tinlarebant, administered for 7 days, in Japanese subjects with Stargardt Disease (STGD1). The Phase 2/3 part of the study will be randomized, double masked, and placebo controlled to evaluate the safety, tolerability, and efficacy of daily doses of 5 mg tinlarebant, administered for 24 months, in subjects with STGD1.

Conditions

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STGD1 Stargardt Disease 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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LBS-008, Tinlarebant

5 mg tablet taken orally once a day

Group Type EXPERIMENTAL

Tinlarebant

Intervention Type DRUG

5 mg tablet

Placebo

Placebo tablets for tinlarebant 5 mg prepared similarly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets

Interventions

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Tinlarebant

5 mg tablet

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type DRUG

Other Intervention Names

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LBS-008

Eligibility Criteria

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Inclusion Criteria

* Subjects must have clinically diagnosed STGD1 with at least one mutation identified in the ABCA4 gene.
* Subjects must have a defined aggregate atrophic lesion in 1 or both eyes.
* Minimum BCVA is required in the study eye

Exclusion Criteria

* Any ocular disease other than STGD1 that, in the opinion of the investigator, would complicate assessment of a treatment effect.
* History of ocular surgery in the study eye in the last 3 months.
* Any prior gene therapy.

Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No