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LBS-008, Tinlarebant for Stargardt disease (DRAGON II Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Belite Bio, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to month 24

Awards & highlights

DRAGON II Trial Summary

This trial aims to test whether tinlarebant is safe and effective for treating Stargardt Disease.

Who is the study for?

This trial is for individuals with Stargardt Disease, a type of inherited eye disorder that causes vision loss. Participants should have a diagnosis of this condition to be eligible.Check my eligibility

What is being tested?

The study is testing the effectiveness and safety of a drug called Tinlarebant compared to a placebo in treating Stargardt Disease. It's designed to see if Tinlarebant can help with symptoms or slow down progression.See study design

What are the potential side effects?

Possible side effects from Tinlarebant are not detailed here, but typically could include reactions at the site of administration, general discomforts like headaches or nausea, and potentially others as observed during the trial.

DRAGON II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have Stargardt disease with a confirmed ABCA4 gene mutation.

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I have a specific type of eye damage in one or both eyes.

DRAGON II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy

Secondary outcome measures

Change in BCVA measured by the ETDRS method

To measure the annualized rate of change in total area of atrophy

DRAGON II Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LBS-008, TinlarebantExperimental Treatment1 Intervention

5 mg tablet taken orally once a day

Group II: PlaceboPlacebo Group1 Intervention

Placebo tablets for tinlarebant 5 mg prepared similarly

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Belite Bio, IncLead Sponsor

6 Previous Clinical Trials

672 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to be enrolled as a participant in this medical study?

"In this research study, individuals aged between 12 and 20 years with a diagnosis of Stargardt disease are eligible to participate. The trial aims to enroll a total of 60 candidates."

Answered by AI

Are new participants still being accepted for enrollment in this research study?

"Based on information from clinicaltrials.gov, recruitment for this particular study has concluded. The initial posting date was 6/1/2024 with the most recent update occurring on 4/26/2024. Despite this trial no longer accepting participants, there are currently 170 alternative studies actively seeking enrollees."

Answered by AI

Does this clinical trial include individuals older than 30 years?

"Individuals aged between 12 and 20 are eligible for participation in this research project. There are specifically 12 trials tailored to those under 18 years old, while there are a total of 164 trials targeting individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06388083.

All > Stargardt Disease