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)
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Basilea, Losanna
(BASEC)
Sponsor
Belite Bio Inc. Cayman Islands Fortrea Switzerland AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Studienzentrum
+41 (0) 61 265 86 86
clinicaltrialcenter@clutteriob.chAugenklinik Universitätsspital Basel
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
19.04.2024
(BASEC)
ID di studio ICTRP
NCT05949593 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy (ICTRP)
Malattie studiate
Geographic Atrophy (ICTRP)
Intervento studiato
Drug: TinlarebantDrug: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Belitebio Clinical Operations, clinicaltrial@belitebio.com, +886 972 080 097 (ICTRP)
ID secondari
LBS-008-CT05 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05949593 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile