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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 May 2025
• Main ID: NCT05348785
• Date of registration: 04/04/2022
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: 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 LUMA
• Scientific title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants With Parkinson's Disease
• Date of first enrolment: April 19, 2022
• Target sample size: 650
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05348785
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Canada, China, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion 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 less than or equal to (=)50
at screening

Key Exclusion 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.

- Montreal Cognitive Assessment (MoCA) score <24 at the screening visit.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.


Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: BIIB122

Drug: BIIB122-Matching Placebo

Primary Outcome(s)

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 [Time Frame: Up to Week 144]

Secondary Outcome(s)

Time to Confirmed Worsening in MDS-UPDRS Part II Score Over the Treatment Period [Time Frame: Up to a minimum of 48 weeks and a maximum of 144 weeks]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Up to Week 146]

Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score [Time Frame: From Baseline up to Week 48]

Change From Baseline in MDS-UPDRS Parts II and III Combined Score [Time Frame: From Baseline up to Week 48]

Time to Confirmed Worsening in Modified Schwab and England Activities of Daily Living Scale (mSE-ADL) Over the Treatment Period [Time Frame: Up to a minimum of 48 weeks and a maximum of 144 weeks]

Secondary ID(s)

2023-505645-12

283PD201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Denali Therapeutics Inc.