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

Last updated: February 16, 2026
Sponsor: Denali Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Dyskinesias

Dystonias

Tic Disorders

Treatment

BIIB122 225 mg

BIIB122-Matching Placebo

Clinical Study ID

NCT06602193
DNLI-C-0009
  • Ages > 30
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 LRRK2variant.

  • Have a clinical diagnosis of PD meeting the Movement Disorder Society ClinicalDiagnostic Criteria.

Exclusion

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 theinvestigator, within 5 years of the screening visit.

  • Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy orprogressive supranuclear palsy) or evidence of drug-induced parkinsonism.

  • Have previously participated or are currently participating in the BIIB122 LUMAstudy (Study 283PD201).

  • Have previously participated or are currently participating in a gene therapy studyfor 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) overtime (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanentphysical 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

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: BIIB122 225 mg
Phase: 2
Study Start date:
October 24, 2024
Estimated Completion Date:
February 28, 2028

Connect with a study center

  • Technische Universität Dresden

    Dresden,
    Germany

    Site Not Available

  • Technische Universität Dresden

    Dresden 2935022,
    Germany

    Active - Recruiting

  • University of Lübeck

    Lübeck,
    Germany

    Site Not Available

  • University of Lübeck

    Lübeck 2875601,
    Germany

    Active - Recruiting

  • University Hospital Tübingen

    Tübingen,
    Germany

    Site Not Available

  • University Hospital Tübingen

    Tübingen 2820860,
    Germany

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva 293918,
    Israel

    Active - Recruiting

  • Movement Disorders Institute, Sheba Medical Center

    Ramat Gan 293788,
    Israel

    Active - Recruiting

  • Tel Aviv Medical Center

    Tel Aviv 293397,
    Israel

    Active - Recruiting

  • Hospital Universitari General de Catalunya

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona 3128760,
    Spain

    Active - Recruiting

  • Hospital Universitari General de Catalunya

    Barcelona 3128760,
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760,
    Spain

    Active - Recruiting

  • Hospital Universitario Donostia

    Donostia,
    Spain

    Site Not Available

  • Hospital Universitario Donostia

    Donostia / San Sebastian 3110044,
    Spain

    Active - Recruiting

  • Universitary Hospital La Princesa

    Madrid,
    Spain

    Site Not Available

  • Universitary Hospital La Princesa

    Madrid 3117735,
    Spain

    Active - Recruiting

  • IDIVAL/University Hospital Marques de Valdecilla

    Santander,
    Spain

    Site Not Available

  • IDIVAL/University Hospital Marques de Valdecilla

    Santander 3109718,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Seville 2510911,
    Spain

    Active - Recruiting

  • Cedars-Sinai Department of Neurology

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • Cedars-Sinai Department of Neurology

    Los Angeles 5368361, California 5332921 90048
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94158
    United States

    Active - Recruiting

  • Parkinson's Disease and Movement Disorders Center

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center

    New York, New York 10003
    United States

    Site Not Available

  • Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center

    New York 5128581, New York 5128638 10003
    United States

    Active - Recruiting

  • Evergreen Health Laboratory

    Kirkland, Washington 98034
    United States

    Site Not Available

  • Inland Northwest Research

    Spokane, Washington 99202
    United States

    Site Not Available

  • Evergreen Health Laboratory

    Kirkland 5799841, Washington 5815135 98034
    United States

    Active - Recruiting

  • Inland Northwest Research

    Spokane 5811696, Washington 5815135 99202
    United States

    Active - Recruiting

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