2025-522460-33-00招募中3 期
An Open-Label, Single-Arm, 3-Year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Subjects with Stargardt Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 5
- 主要终点
- Change in DDAF (Definitely decreased autofluorescence) assessed by FAF (Fundus autofluorescence) photography
研究概览
简要总结
To evaluate long-term systemic and ocular safety and tolerability of tinlarebant
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
LBS-008
Test
干预措施: LBS-008 (Drug)
结局指标
主要结局
Change in DDAF (Definitely decreased autofluorescence) assessed by FAF (Fundus autofluorescence) photography
Change in DDAF (Definitely decreased autofluorescence) assessed by FAF (Fundus autofluorescence) photography
Change in QDAF (Questionably decreased autofluorescence) assessed by FAF (Fundus autofluorescence) photography
Change in QDAF (Questionably decreased autofluorescence) assessed by FAF (Fundus autofluorescence) photography
Change in DAF (Decreased autofluorescence) assessed by FAF (Fundus autofluorescence) photography
Change in DAF (Decreased autofluorescence) assessed by FAF (Fundus autofluorescence) photography
次要结局
未报告次要终点
研究者
Chief Medical Officer
Scientific
Belite Bio Inc.
研究点 (5)
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