Calendario›SNY›ORG101 · OREA
ORG101 · OREA
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
Ensayo de Sanofi en Acne Vulgaris · Acne (del registro, en inglés).
Más ensayos de: Acné vulgar.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 38
- Centros
- 6
- Fin del objetivo primario
- nov 2023
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2021.
Qué mide
Incidence of solicited and unsolicited local and/or systemic adverse events (AEs) (7 days following each vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroAcne vulgaris, or acne, is one of the most prevalent diseases worldwide, with skin conditions being one of the top causes of years lived with disability and non-fatal disease burden. Despite being one of the most prevalent diseases worldwide, the most widely used treatments in acne have changed little in the past 30 years. To date there is still no effective treatment that can prevent and cure this disease. The currently available acne therapies have been discovered several decades ago, and almost no progress was made in developments of novel, breakthrough treatment approaches. The present randomized, placebo-controlled, dose escalation, Phase 1 trial (ORI-101-PAC) is intended to investigate the safety, tolerability and immunogenicity of an acne vulgaris vaccine (ORI-A-ce001) at three different dose levels in subjects aged ≥18 years suffering from moderate facial acne vulgaris who are otherwise healthy. The present study will also generate preliminary data on efficacy (inflammatory and non-inflammatory acne lesion counts, acne severity), immunogenicity and functionality of the vaccine, as well as a possible impact on skin microbiome composition. Control groups receiving placebo are included. Data from this trial will be used to inform the design of future studies.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05131373), actualizada en ene 2024.