NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease

NCT05244304

CompletedPhase 3

Sponsor: Belite Bio, Inc

Conditions: Stargardt Disease 1

Interventions: Tinlarebant, Placebo

Countries: United States, Australia, Belgium, China, France, Germany, Hong Kong, Netherlands

The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1

Eligibility overview

Sex: ALL

Age: 12 Years to 20 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male or female subjects 12 to 20 years old, inclusive.
* Subject must have clinically diagnosed STGD1 (Stargardt disease 1) with at least 1 mutation identified in the ABCA4 gene.
* Subject must have a defined aggregate atrophic lesion size within 3 disc areas (7.62 mm2), as imaged by FAF in the study eye Subjects must have a BCVA of 20/200 or better for the study eye based on ETDRS letter score
* Subject and their parent(s) or legal guardian are willing to provide their consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Human Research Ethics Committee (HREC)-approved informed consent form (ICF) prior to participating in any study-related procedures.
* Subject agrees to comply with all protocol requirements.

Exclusion Criteria:

* Any ocular disease other than Stargardt (STGD1) at baseline 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.
* Investigational drug use of any kind in the last 3 months or within 5 half-lives of the investigational drug, whichever is shorter.
* Any prior gene therapy.
* Vitamin A (retinol) deficiency as defined as a retinol serum level less than 20 mcg/dL (=0.7 μmol/L).

Locations (19)

Palo Alto, California, United States
Minneapolis, Minnesota, United States
Salt Lake City, Utah, United States
Westmead, New South Wales, Australia
East Melbourne, Victoria, Australia
South Brisbane, Australia
Ghent, Belgium
Beijing, China
Shanghai, China
Paris, France
Bonn, Germany
Tübingen, Germany
Kowloon, Hong Kong
Nijmegen, Netherlands
Basel, Switzerland
Taipei, Taiwan
Taoyuan City, Taiwan
London, United Kingdom
Southampton, United Kingdom