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
NCT ID: NCT05348785
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
650 participants
INTERVENTIONAL
2022-04-19
2026-03-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BIIB122 225 mg
Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks.
Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.
BIIB122
Administered as specified in the treatment arm
BIIB122 Matching Placebo
Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.
Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.
BIIB122-Matching Placebo
Administered as specified in the treatment arm
Interventions
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BIIB122
Administered as specified in the treatment arm
BIIB122-Matching Placebo
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
30 Years
80 Years
ALL
No
Sponsors
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Denali Therapeutics Inc.
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
University of Southern California
Los Angeles, California, United States
Cedars Sinai
Los Angeles, California, United States
SC3 Research Group Inc.
Pasadena, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, United States
Invicro
New Haven, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
University of Miami
Miami, Florida, United States
Adventist Health System/Sunbelt, Inc.
Orlando, Florida, United States
USF Health Byrd Institute
Tampa, Florida, United States
Hawaii Pacific Neuroscience, LLC
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Boston University Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Mount Sinai Beth Israel
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Duke Movement Disorders Clinic
Durham, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
UPHS
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Neurology Clinic, PC
Cordova, Tennessee, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Virginia Commonwealth University Department of Neurology
Richmond, Virginia, United States
Evergreen Hospital Medical Center
Kirkland, Washington, United States
Inland Northwest Research
Spokane, Washington, United States
Medizinische Universität
Innsbruck, Tyrol, Austria
Klinik Ottakring
Vienna, , Austria
University of Calgary
Calgary, Alberta, Canada
True North Clinical Research
Halifax, Nova Scotia, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
CHUM Centre de Recherche
Montreal, Quebec, Canada
Montreal Neurological Institute
Montreal, Quebec, Canada
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Second Affiliated Hospital of Soochow University
Jiangsu, Jiangsu, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Hôpital de la Timone
Marseille, Bouches-du-Rhône, France
Hopital Purpan
Toulouse, Haute Garonne, France
Hopital Gui de Chauliac
Montpellier, Herault, France
CHU Rennes - Hopital Pontchaillou
Rennes, Ille Et Vilaine, France
CHU Nantes - Hopital Nord Laën
Loire-Atlantique, Loire-Atlantique, France
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Puy De Dome, France
Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer
Bron, Rhone, France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Hopital Henri Mondor
Paris, , France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Klinikum der Universität München
Munich, Bavaria, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, Germany
Paracelsus-Elena-Klinik Kassel
Kassel, Hesse, Germany
Philipps University of Marburg
Marburg, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Katholisches Klinikum Bochum gGmbH
Bochum, North Rhine-Westphalia, Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, Schleswig-Holstein, Germany
Rabin Medical Center
Petah Tikva, , Israel
Center Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
I.R.C.C.S. Neuromed
Diego, Centonze, Italy
IRCCS-Institute of Neurological Sciences of Bologna
Bologna, , Italy
Azienda Ospedaliera Spedali
Brescia, , Italy
Azienda Ospedaliero Universitaria Policlinico 'Gaspare Rodolico - San Marco' (Presidio G. Rodolico)
Catania, , Italy
Ospedale Clinicizzato SS. Annu
Chieti, , Italy
Fondazione
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
AOU Luigi Vanvitelli
Napoli, , Italy
AO Universitaria Pisana
Pisa, , Italy
IRCCS San Raffaele Pisana
Roma, , Italy
Okinawa Prefectural Nanbu
Haeburu, Okinawa, Japan
Tazuke-kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, Japan
NHO Asahikawa Medical Center
Asahikawa-shi, , Japan
Himeji Central
Himeji-shi, , Japan
Sendai Nishitaga National Hospital
Sendai, , Japan
Juntendo University
Tokyo, , Japan
Brain Research Center Amsterdam
Amsterdam, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Brain Research Center Zwolle B.V.
Zwolle, , Netherlands
Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K
Oświęcim, Katowice, Poland
NeuroProtect Sp. z o.o.
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Neuromed
Bydgoszcz, , Poland
Nzoz Novo-Med
Katowice, , Poland
INSULA Centrum Badan Klinicznych
Warsaw, , Poland
MD Clinic Praga
Warsaw, , Poland
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Marques
Santanda, Santanda, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital de Cruces
Barakaldo, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Policlinica Gipuzkoa
Donostia / San Sebastian, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
University Hospitals Plymouth
Plymouth, Devon, United Kingdom
Re:Cognition Health Ltd (London)
London, Greater London, United Kingdom
Charing Cross Hospital
London, Greater London, United Kingdom
The National Hospital for Neurology & Neurosurgery
London, Greater London, United Kingdom
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, United Kingdom
NeuroClin Limited
Motherwell, Strathclyde, United Kingdom
Newcastle University
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Re:Cognition Health - Birmingham
Birmingham, West Midlands, United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Countries
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References
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Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Jul 18:1-32. doi: 10.1080/1028415X.2025.2531356. Online ahead of print.
Other Identifiers
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2023-505645-12
Identifier Type: OTHER
Identifier Source: secondary_id
283PD201
Identifier Type: -
Identifier Source: org_study_id
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