BridgeMD
An Open-Label, Single-Arm, 3-Year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Subjects with Stargardt Disease
EU CTIS ID: 2025-522460-33-00
What this study is testing
To evaluate long-term systemic and ocular safety and tolerability of tinlarebant
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject has completed 24-month treatment in LBS-008-CT02 or LBS-008-CT03 trial and has also completed the tests and assessments required end-of-treatment visit.
You likely can't join if
- Ocular surgery in the study eye in the previous 3 months.
- Unwillingness or inability to provide signed informed consent prior to participation in any study-related procedures.
- In the opinion of the Investigator, the subject is not suitable for entry into the study.
- Use of prescription medications such as Isotretinoin (13-cis-retinoic acid) or other retinol modulators or derivatives which may impact the effect of the study drug.
- Use of any known drugs or supplements that are inhibitors/inducers of cytochrome P450 (CYP) enzymes (e.g., rifampin, barbiturates, phenothiazines, cimetidine, carbamazepine, St. John’s wort) within 30 days of study drug administration or consumption of foods that are inhibitors/inducers of CYP3A4 (e.g., grapefruit, bitter orange [Seville orange], pomegranate, or star fruit) within 48 hours of study drug administration, and that, in the Investigator’s judgement, may impact subjects’ safety or the validity of the study results.
- Presence of life-threatening disease(s), including current treatment for malignancies.
See the full eligibility criteria
- Subject has completed 24-month treatment in LBS-008-CT02 or LBS-008-CT03 trial and has also completed the tests and assessments required end-of-treatment visit.
- Ocular surgery in the study eye in the previous 3 months.
- Unwillingness or inability to provide signed informed consent prior to participation in any study-related procedures.
- In the opinion of the Investigator, the subject is not suitable for entry into the study.
- Use of prescription medications such as Isotretinoin (13-cis-retinoic acid) or other retinol modulators or derivatives which may impact the effect of the study drug.
- Use of any known drugs or supplements that are inhibitors/inducers of cytochrome P450 (CYP) enzymes (e.g., rifampin, barbiturates, phenothiazines, cimetidine, carbamazepine, St. John’s wort) within 30 days of study drug administration or consumption of foods that are inhibitors/inducers of CYP3A4 (e.g., grapefruit, bitter orange [Seville orange], pomegranate, or star fruit) within 48 hours of study drug administration, and that, in the Investigator’s judgement, may impact subjects’ safety or the validity of the study results.
- Presence of life-threatening disease(s), including current treatment for malignancies.
- Current alcohol or other substance abuse.
- Alanine transaminase/aspartate aminotransferase (ALT/AST) > 2.5× the Upper Limit of Normal (ULN) based on last available report.
- Renal insufficiency, as defined by an eGFR (Bedside Schwartz) < 30 mL/min/1.73m2 based on last available report.
- Pregnant or nursing females and females of childbearing potential who are unwilling or unable to use an acceptable method of contraception (or abstinence). Females must have a negative pregnancy during the treatment period.
- Male subject who does not agree that female spouse/partner will use adequate contraception (i.e., condoms) or be of non-childbearing potential (i.e., surgically sterile).
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- China
- Hong Kong
- Australia
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; China; Hong Kong; Australia; Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.