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BIIB122 · LUMA

A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80

Ensayo de BIOGEN INC. en Enfermedad de Parkinson.

Más ensayos de: Enfermedad de Parkinson.

Fase

Fase 2

Estado

Completado

Participantes

650

previstos

Centros

113

Fin del objetivo primario

mar 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en abr 2022.

Qué mide

Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score Over the Treatment Period (del registro, en inglés) (hasta la semana 144)

Cómo lo describe el promotor

En el documentoEn inglés, del registroIn this study, researchers will learn more about BIIB122 in participants with early-stage Parkinson's disease (PD). The study will include adults aged 30 to 80 who were diagnosed with PD within 2 years of starting the study. The main objective of the study is to learn about the effect BIIB122 has on slowing down the worsening of PD symptoms. The main question researchers want to answer is: \- How long does it take for PD symptoms to worsen during BIIB122 treatment? Researchers will answer this and other questions by measuring the symptoms of PD over time using a variety of scoring tools. These include the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the modified Schwab and England Activities of Daily Living Scale (mSE-ADL). The MDS-UPDRS is used to measure symptoms of PD. It has 4 parts: Part I, II, III, and IV. Each part measures different aspects of motor and non-motor symptoms. The mSE-ADL measures a participant's ability to perform daily activities or personal chores. Researchers will also learn more about the safety of BIIB122. They will check participants for adverse events. Adverse events are unwanted health problems that may or may not be caused by the study drug. The study will be done as follows: * Participants will be randomly assigned to take either BIIBB122 or placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know if the participants are receiving BIIB122 or placebo. * Participants will take BIIB122 or placebo tablets by mouth once a day. * The treatment period for each participant will last between 48 and 144 weeks. * There will be a safety follow-up period for 2 weeks after the last dose of BIIB122. * In total, participants will have up to 29 study visits. * Participants will stay in the study for at least 1 year, up to about 3 years.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05348785), actualizada en jun 2026.