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GLPG0634
Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
Ensayo de Lakefront Biotherapeutics NV en Enfermedad de Crohn.
Más ensayos de: Enfermedad de Crohn.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 175
- Centros
- 63
- Fin del objetivo primario
- nov 2015
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2014.
Qué mide
Percentage of subjects achieving clinical remission at Week 10 (del registro, en inglés) (semana 10)
Cómo lo describe el promotor
En el documentoEn inglés, del registro* 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 weeks in addition to their stable background treatment. * During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.
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| OM336 | Fase 1 | Reclutando pacientes | jun 2027 (prevista) |
| Long-Term Follow-Up Study of Gamgertamig | no aplica | Aún sin reclutar | dic 2029 (prevista) |
| GLPG CAR T-cell therapy · Hesperia | Fase 3 | Reclutando pacientes | jul 2039 (prevista) |
| GLPG5101 · Atalanta-1 | Fase 1/2 | Interrumpido | may 2026 (real) |
| GLPG3667 · GALARISSO | Fase 2 | Completado | oct 2025 (real) |
Todos los de LKFT, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02048618), actualizada en feb 2016.