Clinical trial NCT05348785: 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
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Early-stage Parkinson Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Denali Therapeutics Inc.
First posted: 2022-04-27
Enrollment: 650
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, researchers will learn more about BIIB122 in participants with early-stage Parkinson's disease (PD). The study will include adults aged 30 to 80 who were diagnosed with PD within 2 years of starting the study.

The main objective of the study is to learn about the effect BIIB122 has on slowing down the worsening of PD symptoms. The main question researchers want to answer is:

- How long does it take for PD symptoms to worsen during BIIB122 treatment?

Researchers will answer this and other questions by measuring the symptoms of PD over time using a variety of scoring tools. These include the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the modified Schwab and England Activities of Daily Living Scale (mSE-ADL).

The MDS-UPDRS is used to measure symptoms of PD. It has 4 parts: Part I, II, III, and IV. Each part measures different aspects of motor and non-motor symptoms. The mSE-ADL measures a participant's ability to perform daily activities or personal chores.

Researchers will also learn more about the safety of BIIB122. They will check participants for adverse events. Adverse events are unwanted health problems that may or may not be caused by the study drug.

The study will be done as follows:

* Participants will be randomly assigned to take either BIIBB122 or placebo. A placebo looks like the study drug but contains no real medicine.
* Neither the researchers nor the participants will know if the participants are receiving BIIB122 or placebo.
* Participants will take BIIB122 or placebo tablets by mouth once a day.
* The treatment period for each participant will last between 48 and 144 weeks.
* There will be a safety follow-up period for 2 weeks after the last dose of BIIB122.
* In total, participants will have up to 29 study visits.
* Participants will stay in the study for at least 1 year, up to about 3 years.

Detailed description: BIIB122 is an investigational central nervous system-penetrant small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2). Participants who completed the early termination (ET) visit of the study 283PD302 (NCT05418673) would be eligible for screening of this study and if enrolled, these participants are not eligible for the sub studies of 283PD201.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Up to Week 144
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 146
measure: Time to Confirmed Worsening in MDS-UPDRS Part II Score Over the Treatment Period
timeFrame: Up to a minimum of 48 weeks and a maximum of 144 weeks
measure: Change From Baseline in MDS-UPDRS Parts II and III Combined Score
timeFrame: From Baseline up to Week 48
measure: Time to Confirmed Worsening in Modified Schwab and England Activities of Daily Living Scale (mSE-ADL) Over the Treatment Period
timeFrame: Up to a minimum of 48 weeks and a maximum of 144 weeks
measure: Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score
timeFrame: From Baseline up to Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Pasadena
country: United States
facility: SC3 Research Group Inc.
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (UCSF)
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Englewood
country: United States
facility: CenExel Rocky Mountain Clinical Research
state: Colorado
city: New Haven
country: United States
facility: Invicro
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Adventist Health System/Sunbelt, Inc.
state: Florida
city: Tampa
country: United States
facility: USF Health Byrd Institute
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience, LLC
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Durham
country: United States
facility: Duke Movement Disorders Clinic
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: UPHS
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Cordova
country: United States
facility: Neurology Clinic, PC
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Department of Neurology
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Hospital Medical Center
state: Washington
city: Spokane
country: United States
facility: Inland Northwest Research
state: Washington
city: Innsbruck
country: Austria
facility: Medizinische Universität
state: Tyrol
city: Vienna
country: Austria
facility: Klinik Ottakring
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Halifax
country: Canada
facility: True North Clinical Research
state: Nova Scotia
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM Centre de Recherche
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Jiangsu
country: China
facility: Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Marseille
country: France
facility: Hôpital de la Timone
state: Bouches-du-Rhône
city: Toulouse Cedex 09
country: France
facility: Hopital Purpan
state: Haute Garonne
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
state: Herault
city: Rennes
country: France
facility: CHU Rennes - Hopital Pontchaillou
state: Ille Et Vilaine
city: Clermont Ferrand Cedex
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied
state: Puy De Dome
city: Bron
country: France
facility: Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer
state: Rhone
city: Loire-Atlantique
country: France
facility: CHU Nantes - Hopital Nord Laën
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Henri Mondor
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden Wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden Wuerttemberg
city: Muenchen
country: Germany
facility: Klinikum der Universität München
state: Bayern
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TU Muenchen
state: Bayern
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
state: Bayern
city: Kassel
country: Germany
facility: Paracelsus-Elena-Klinik Kassel
state: Hessen
city: Marburg
country: Germany
facility: Philipps University of Marburg
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH
state: Nordrhein Westfalen
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf AoeR
state: Nordrhein Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
state: Sachsen
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
state: Schleswig Holstein
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Center Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Diego
country: Italy
facility: I.R.C.C.S. Neuromed
state: Centonze
city: Bologna
country: Italy
facility: IRCCS-Institute of Neurological Sciences of Bologna
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico 'Gaspare Rodolico - San Marco' (Presidio G. Rodolico)
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS. Annu
city: Milano
country: Italy
facility: Fondazione
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Napoli
country: Italy
facility: AOU Luigi Vanvitelli
city: Pisa
country: Italy
facility: AO Universitaria Pisana
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana
city: Haeburu
country: Japan
facility: Okinawa Prefectural Nanbu
state: Okinawa
city: Osaka-shi
country: Japan
facility: Tazuke-kofukai Medical Research Institute Kitano Hospital
state: Osaka-Fu
city: Asahikawa-shi
country: Japan
facility: NHO Asahikawa Medical Center
city: Himeji-shi
country: Japan
facility: Himeji Central
city: Sendai-shi
country: Japan
facility: Sendai Nishitaga National Hospital
city: Tokyo
country: Japan
facility: Juntendo University
city: Amsterdam
country: Netherlands
facility: Brain Research Center Amsterdam
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Zwolle
country: Netherlands
facility: Brain Research Center Zwolle B.V.
city: Oswiecim
country: Poland
facility: Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K
state: Katowice
city: Warsaw
country: Poland
facility: NeuroProtect Sp. z o.o.
state: Mazowieckie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Neuromed
city: Katowice
country: Poland
facility: Nzoz Novo-Med
city: Warszawa
country: Poland
facility: INSULA Centrum Badan Klinicznych
city: Warszawa
country: Poland
facility: MD Clinic Praga
city: Sant Cugat del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Barakaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: San Sebastian
country: Spain
facility: Policlinica Gipuzkoa
city: Santanda
country: Spain
facility: Hospital Universitario Marques
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth
state: Devon
city: London
country: United Kingdom
facility: Re:Cognition Health Ltd (London)
state: Greater London
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: Greater London
city: London
country: United Kingdom
facility: The National Hospital for Neurology & Neurosurgery
state: Greater London
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Greater Manchester
city: Motherwell
country: United Kingdom
facility: NeuroClin Limited
state: Strathclyde
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle University
state: Tyne And Wear
city: Birmingham
country: United Kingdom
facility: Re:Cognition Health - Birmingham
state: West Midlands
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: