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Filgotinib · CAPYBARA
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Ensayo de Lakefront Biotherapeutics NV en colitis ulcerosa.
Más ensayos de: Colitis ulcerosa.
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 22
- Centros
- 50
- Fin del objetivo primario
- oct 2023
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jul 2022.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «the planned number of participants needed to ensure adequate precision in the estimations and to draw meaningful conclusions was unlikely to be met, questioning the scientific value and ethical grounds for study continuation».
Qué mide
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) (semana 48)
Cómo lo describe el promotor
En el documentoEn inglés, del registroParticipants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over and randomized in this study. The primary objective of this study was to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib once daily for whom the dose was decreased to 100 mg once daily compared to participants remaining on 200 mg once daily.
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|---|---|---|---|
| OM336 | Fase 1 | Reclutando pacientes | dic 2026 (prevista) |
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| 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 (NCT05479058), actualizada en sep 2024.