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AP02 · AURA-IPF
AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
Ensayo de Avalyn Pharma Inc. en Fibrosis pulmonar idiopatica (FPI).
Más ensayos de: Fibrosis pulmonar idiopática.
- Fase
- Fase 2
- Estado
- Reclutando pacientes
- Participantes
- 160
- Centros
- 24
- Fin del objetivo primario
- dic 2026
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2026.
Qué mide
Cambio respecto al valor basal en la capacidad vital forzada matutina previa a la dosis en la semana 12 (From enrollment to the end of treatment at 12 weeks) (del registro, en inglés)
Qué se prueba
Se comparan dos dosis de AP02 frente a placebo, administradas por nebulizador dos veces al día durante 12 semanas, en pacientes con fibrosis pulmonar idiopática.
Lo que dice el documentoResearchers will compare two different doses of AP02 to a placebo (a look-alike substance that contains no drug) to see if AP02 works to treat IPF. Participants are put into 1 of 3 groups randomly, which means by chance and will take AP02 or a placebo two times every day for 12 weeks by using a nebulizer, which is a device that provides medicine to the lungs via inhalation.
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Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability. Adults 40 years of age or older with IPF who meet the inclusion and exclusion criteria can participate in this study if they are not currently on treatment for IPF, and if treated with oral nintedanib or pirfenidone, have stopped the medication for at least 3 months. Researchers will compare two different doses of AP02 to a placebo (a look-alike substance that contains no drug) to see if AP02 works to treat IPF. Participants are put into 1 of 3 groups randomly, which means by chance and will take AP02 or a placebo two times every day for 12 weeks by using a nebulizer, which is a device that provides medicine to the lungs via inhalation. Participants will visit the office 6 times and receive 1 phone call over a 16-week period. At site visits doctors regularly perform breathing tests that measure how well the lungs are working, give the patient questionnaires and will check the participants' health.
Más ensayos de AVLN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| AP01 | Fase 2 | En marcha, sin reclutar | jun 2027 (prevista) |
| AP01 · SAIL | Fase 2 | Reclutando pacientes | dic 2031 (prevista) |
Todos los de AVLN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT07194382), actualizada en ago 2026.