Phase III, multicenter, randomized, double-masked, placebo-controlled study of Tinlarebant to investigate safety and efficacy in the treatment of geographic atrophy (the PHOENIX study)
Résumé de l'étude
This study aims to further investigate the safety and efficacy of Tinlarebant in the treatment of geographic atrophy. The current phase III study for the treatment of geographic atrophy (GA) with Tinlarebant is based on findings from completed clinical phase I studies and the ongoing clinical phase II study. In phase I studies, the proposed dose of 5 mg of Tinlarebant, administered orally once daily to healthy adult subjects, was investigated and found to be safe and well tolerated. This study will enroll patients with small GA lesions whose vision has not been significantly impaired. Previous studies show that patients with smaller lesions respond better to oral therapies. This study is a placebo-controlled study. The proposed treatment dose and the proposed treatment regimen were selected based on results from previous clinical studies on safety and pharmacokinetics (how the investigational drug interacts with the body). The primary method for testing whether this treatment is effective is measuring the change in size of the atrophic lesion. This is an appropriate method as the growth of atrophic lesions relates to the loss of photoreceptors (the cells in the retina that can convert light into signals that may stimulate biological processes) and the subsequent loss of vision. This method has been used in many previous and current studies for the treatment of GA.
(BASEC)
Intervention étudiée
Tinlarebant (LBS-008) is an oral, once-daily treatment that targets circulating RBP4 (the carrier protein that transports vitamin A to the eye) to reduce vitamin A supply to the eye and thus slow or halt the progression of geographic atrophy (GA) in dry AMD.
(BASEC)
Maladie en cours d'investigation
age-related macular degeneration (AMD)
(BASEC)
1. Male or female, aged 60-85 years 2. Patients must have a confirmed diagnosis of GA with atrophic lesions (diagnosed as GA) in one or both eyes 3. The fundus must be able to be adequately examined at the time of study enrollment (BASEC)
Critères d'exclusion
1. Any GA lesions greater than 10 mm2 in the examined eye 2. Incisional eye surgery on the eye to be examined within the last 3 months and/or planned intraocular surgery (including cataract surgery) on the eye to be examined during the study 3. Presence of diabetic macular edema or macular disease in either eye (BASEC)
Lieu de l’étude
Bâle, Lausanne
(BASEC)
Sponsor
Belite Bio Inc. Cayman Islands Fortrea Switzerland AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Studienzentrum
+41 (0) 61 265 86 86
clinicaltrialcenter@clutteriob.chAugenklinik Universitätsspital Basel
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
19.04.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT05949593 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Phase 3, Multicenter, Randomized, Double-masked, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study) (BASEC)
Titre académique
PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study) (ICTRP)
Titre public
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy (ICTRP)
Maladie en cours d'investigation
Geographic Atrophy (ICTRP)
Intervention étudiée
Drug: TinlarebantDrug: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both
eyes.
- Minimum BCVA is required in the study eye
Exclusion Criteria:
- The presence of diabetic macular edema or macular disease in either eye.
- Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy,
or any other retinal vascular disease in either eye.
- Uncontrolled diagnosed glaucoma in the study eye (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size (ICTRP)
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale;To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT) (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Belitebio Clinical Operations, clinicaltrial@belitebio.com, +886 972 080 097 (ICTRP)
ID secondaires
LBS-008-CT05 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05949593 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible