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GLPG2222 150 mg q.d.

A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis

Ensayo de Lakefront Biotherapeutics NV en Fibrosis quistica.

Más ensayos de: Fibrosis quística.

Fase

Fase 2

Estado

Completado

Participantes

37

previstos

Centros

22

Fin del objetivo primario

ago 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2017.

Qué mide

Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR mutation and a second gating (class III) mutation and on stable treatment with ivacaftor. Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.

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Ficha completa en ClinicalTrials.gov (NCT03045523), actualizada en nov 2017.