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Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) Phase 2 50 Randomized Double-Blind Placebo-Controlled

Recruiting
Clinical Trial NCT06602193 is designed to study Treatment for Parkinson Disease. It is a Phase 2 interventional study that is recruiting, having started on 24 October 2024, with plans to enroll 50 participants. Led by Denali Therapeutics Inc., it is expected to complete by 28 February 2028. The latest data from ClinicalTrials.gov was last updated on 18 February 2026.
Brief 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.
Official 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)

Conditions
Parkinson Disease
Other Study IDs
  • DNLI-C-0009
NCT ID Number
NCT06602193
Start Date (Actual)
2024-10-24
Last Update Posted
2026-02-18
Completion Date (Estimated)
2028-02-28
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
LRRK2
Movement Disorders
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBIIB122 225 mg
Oral 225 mg dose, once daily (QD)
BIIB122 225 mg
Administered as specified in the treatment arm
Placebo ComparatorBIIB122 Matching Placebo
Oral BIIB122 matching placebo, once daily (QD)
BIIB122-Matching Placebo
Administered as specified in the treatment arm
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period
12 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12
12 weeks
Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12
12 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
30 Years
Eligible Sexes
All
  • 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.

  • 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

Denali Therapeutics Inc. logoDenali Therapeutics Inc.
Study Central Contact
Contact: Clinical Trials at Denali Therapeutics, [email protected]
20 Study Locations in 4 Countries

California

Cedars-Sinai Department of Neurology, Los Angeles, California, 90048, United States
Anne Tran, Contact, 310-423-1697, [email protected]
Michele Tagliati, MD, Principal Investigator
Recruiting
University of California San Francisco, San Francisco, California, 94158, United States
Luisa Bolo Dave, Contact, [email protected]
Marta San Luciano Palenzuela, MD, Principal Investigator
Recruiting

Florida

Parkinson's Disease and Movement Disorders Center, Boca Raton, Florida, 33486, United States
Stuart Isaacson, MD, Contact, 561-392-1818, [email protected]
Stuart Isaacson, MD, Principal Investigator
Recruiting

Massachusetts

Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
Jackie Forbes, Contact, 617-667-9885, [email protected]
Ludy Shih, MD, Principal Investigator
Recruiting

New York

Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center, New York, New York, 10003, United States
Ricardo Renvill, Contact, 212-844-6055, [email protected]
Matthew Swan, MD, Principal Investigator
Recruiting

Washington

Evergreen Health Laboratory, Kirkland, Washington, 98034, United States
EvergreenHealth Research Department, Contact, [email protected]
Pinky Agarwal, MD, Principal Investigator
Recruiting
Inland Northwest Research, Spokane, Washington, 99202, United States
Jason Aldred, MD, Contact, 509-960-2818, [email protected]
Jason Aldred, MD, Principal Investigator
Recruiting
Technische Universität Dresden, Dresden, Germany
Marian Kollaske, Contact, [email protected]
Björn Falkenburger, MD, Principal Investigator
Recruiting
University of Lübeck, Lübeck, Germany
Madita Grümmer, Contact, [email protected]
Norbert Brüggemann, MD, Principal Investigator
Recruiting
University Hospital Tübingen, Tübingen, Germany
Susanne Solbrig, Contact, [email protected]
Thomas Gasser, MD, Principal Investigator
Recruiting
Rabin Medical Center, Petah Tikva, Israel
Dana Vhava, Contact, [email protected]
Ruth Djaldetti, MD, Principal Investigator
Recruiting
Movement Disorders Institute, Sheba Medical Center, Ramat Gan, Israel
Adi Saar, Contact, [email protected]
Sharon Hassin, MD, Principal Investigator
Recruiting
Tel Aviv Medical Center, Tel Aviv, Israel
Adi Ezra, Contact, [email protected]
Tanya Gurevich, MD, Principal Investigator
Recruiting
Hospital Clinic de Barcelona, Barcelona, Spain
Pilar Santacruz, Contact, [email protected]
Alicia Garrido, MD, Principal Investigator
Recruiting
Hospital Universitari General de Catalunya, Barcelona, Spain
Susana Andrade, Contact, +3493175715, [email protected]
Ernest Balaguer Martínez, MD, Principal Investigator
Recruiting
Hospital Universitari Vall d'Hebron, Barcelona, Spain
Alejandra Garcia Blanco, Contact, [email protected]
Jorge Hernandez-Vara, MD, Principal Investigator
Recruiting
Hospital Universitario Donostia, Donostia / San Sebastian, Spain
Ioana Croitoru, Contact, [email protected]
Javier Ruiz Martinez, MD, Principal Investigator
Recruiting
Universitary Hospital La Princesa, Madrid, Spain
Pablo Sáinz-Ezquerra, Contact, [email protected]
Lydia Lopez-Manzares, MD, Principal Investigator
Recruiting
IDIVAL/University Hospital Marques de Valdecilla, Santander, Spain
Raquel Martinez, Contact, [email protected]
Jon Infante, MD, Principal Investigator
Recruiting
Hospital Universitario Virgen del Rocio, Seville, Spain
Cristina Gomez Rapela, Contact, [email protected]
Lorena Garrote, Contact, [email protected]
Pablo Mir Rivera, MD, Principal Investigator
Recruiting