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Litifilimab · TOPAZ-1
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Ensayo de BIOGEN INC. en Lupus eritematoso sistemico.
- Fase
- Fase 3
- Estado
- En marcha, sin reclutar
- Participantes
- 548
- Centros
- 164
- Fin del objetivo primario
- sep 2026
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2021.
Qué mide
Porcentaje de participantes que lograron una respuesta segun el Systemic Lupus Erythematosus Responder Index 4 (SRI-4) en la semana 52 (semana 52)
Qué se prueba
Se estudia litifilimab en participantes con lupus eritematoso sistémico con enfermedad activa que ya toman su tratamiento habitual.
Lo que dice el documentoa study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroIn this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: \- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. * All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. * Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.
Más ensayos de BIIB
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Diranersen · CELIA | Fase 2 | En marcha, sin reclutar | mar 2026 (real) |
| BIIB142 | Fase 1 | Reclutando pacientes | ago 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Litifilimab · TOPAZ-2 | Fase 3 | En marcha, sin reclutar | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Litifilimab · AMETHYST | Fase 2/3 | En marcha, sin reclutar | oct 2026 (prevista) |
| Natalizumab | no aplica | En marcha, sin reclutar | oct 2026 (prevista) |
| Felzartamab · TRANSCEND | Fase 3 | En marcha, sin reclutar | dic 2026 (prevista) |
Todos los de BIIB, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04895241), actualizada en feb 2026.