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NCT Number: NCT06602193

Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Technische Universität Dresden, Dresden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years
  • For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years
  • Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.
  • Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.

Exclusion criteria

  • Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit.
  • Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
  • Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201).
  • Have previously participated or are currently participating in a gene therapy study for PD.
  • Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy).
  • Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability).
  • Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature
  • Have abnormal PFT results at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

BIIB122 225 mg

Drug

Administered as specified in the treatment arm

Other names: DNL151

BIIB122-Matching Placebo

Other

Administered as specified in the treatment arm

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12

    Time frame: 12 weeks

  2. Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12

    Time frame: 12 weeks

Other outcomes

  1. Incidence of TEAEs and SAEs during the OLE period

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

Denali Therapeutics Inc.

Industry

Collaborators

  • Biogen

Registry information

Official study title

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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