Phase 2b Study of BIIB122 in Participants with Parkinson's Disease

JRCT ID: jRCT2031220519

Registered date:19/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 24/05/2023
• Target sample size: 640
• Countries of recruitment: United Kingdom,Japan,United States,Japan,Canada,Japan,Israel,Japan,China,Japan
• Study type: Interventional

Intervention(s)

Research Name: BIIB122 (also known as DNL151)
Generic Name: Not applicable
Trade Names: Not applicable
Participants will receive either BIIB122 225 mg or placebo QD orally for up to 144 weeks.

Outcome(s)

• Primary Outcome: Time to confirmed worsening in MDS-UPDRS Parts II and III combined score over the treatment period

Secondary Outcome

-Incidence of AEs and SAEs during the treatment period

-Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period

-Change in MDS-UPDRS Parts II and III combined score from Baseline to Week 48

-Time to confirmed worsening on SE-ADL over the treatment period

-Change in MDS-UPDRS Parts I, II, and III combined score from Baseline to Week 48

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

-Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis.

-Modified Hoehn and Yahr scale Stages 1 to 2 (in OFF state), inclusive, at Screening.

-MDS-UPDRS Parts II and III (in OFF state) combined score <= 40 at Screening.

-Screening genetic test results verifying the absence of a pathogenic LRRK2 variant. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants.

Exclude criteria

-Clinically significant neurological disorder other than PD, including but not limited to stroke, dementia, or seizure, within 5 years of Screening Visit, in the opinion of the Investigator.

-Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.

-MoCA score < 24 at the Screening Visit.

Related Information

• Primary Sponsor: Tsuda Hiroshi
• Secondary ID(s): NCT05348785