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A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson's Disease

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

Matsuda Naoto

Biogen Japan Ltd.

Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027

japan-medinfo@biogen.com

Biogen Japan Medical Information

Biogen Japan Ltd.

Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027

+81-120-560-086

japan-medinfo@biogen.com

Not Recruiting

Feb. 28, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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.

-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.

Both

Parkinson's disease

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.

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

-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

+81-3-5213-0028

Oct. 21, 2022

Yes

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

United Kingdom/United States/Canada/Israel/China