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filgotinib · EQUATOR
A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis
Ensayo de Lakefront Biotherapeutics NV en Psoriatic Arthritis (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 131
- Centros
- 25
- Fin del objetivo primario
- mar 2018
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2017.
Qué mide
Percentage of subjects who have reached ACR20 response as compared to placebo (del registro, en inglés) (semana 16)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 weeks (from Screening visit to Follow-up visit).
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Todos los de LKFT, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03101670), actualizada en abr 2018.