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

NCT05348785 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 283PD2012023-505645-12
• Study Type: interventional
• Target: 650
• Locations: 13 countries
• Sites: 113

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.

Conditions

Parkinson Disease

Keywords

Early-stage Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be completed by the participant. Part III assesses the motor signs of PD and is administered by the rater (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (Range 0-184). A higher score indicates more severe symptoms of PD.

  Up to Week 144

Secondary Outcomes (5)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to Week 144

• Time to Confirmed Worsening in MDS-UPDRS Part II Score Over the Treatment Period

  Up to a minimum of 48 weeks and a maximum of 144 weeks

• Change From Baseline in MDS-UPDRS Parts II and III Combined Score

  From Baseline up to Week 48

• Time to Confirmed Worsening in Modified Schwab and England Activities of Daily Living Scale (mSE-ADL) Over the Treatment Period

  Up to a minimum of 48 weeks and a maximum of 144 weeks

• Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score

  From Baseline up to Week 48

Study Arms (2)

BIIB122 225 mg

EXPERIMENTAL

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.

Drug: BIIB122

BIIB122 Matching Placebo

PLACEBO COMPARATOR

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.

Drug: BIIB122-Matching Placebo

Interventions

BIIB122 DRUG

Administered as specified in the treatment arm

Also known as: DNL151

BIIB122 225 mg

BIIB122-Matching Placebo DRUG

Administered as specified in the treatment arm

BIIB122 Matching Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead
• Denali Therapeutics Inc.: collaborator

Study Sites (113)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

SC3 Research Group Inc.

Pasadena, California, 91105, United States

Location

University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, 80113, United States

Location

Invicro

New Haven, Connecticut, 06510, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Adventist Health System/Sunbelt, Inc.

Orlando, Florida, 32803, United States

Location

USF Health Byrd Institute

Tampa, Florida, 33613, United States

Location

Hawaii Pacific Neuroscience, LLC

Honolulu, Hawaii, 96817, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02421, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Duke Movement Disorders Clinic

Durham, North Carolina, 27705, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

UPHS

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Neurology Clinic, PC

Cordova, Tennessee, 38018, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Virginia Commonwealth University Department of Neurology

Richmond, Virginia, 23298, United States

Location

Evergreen Hospital Medical Center

Kirkland, Washington, 98034, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

Medizinische Universität

Innsbruck, Tyrol, 6020, Austria

Location

Klinik Ottakring

Vienna, 1160, Austria

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

True North Clinical Research

Halifax, Nova Scotia, B3S 1M7, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

CHUM Centre de Recherche

Montreal, Quebec, H2L 4M1, Canada

Location

Montreal Neurological Institute

Montreal, Quebec, H3A 2B4, Canada

Location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Second Affiliated Hospital of Soochow University

Jiangsu, Jiangsu, 215004, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Hôpital de la Timone

Marseille, Bouches-du-Rhône, 13005, France

Location

Hopital Purpan

Toulouse, Haute Garonne, 31059, France

Location

Hopital Gui de Chauliac

Montpellier, Herault, 34295, France

Location

CHU Rennes - Hopital Pontchaillou

Rennes, Ille Et Vilaine, 35033, France

Location

CHU Nantes - Hopital Nord Laën

Loire-Atlantique, Loire-Atlantique, 44093, France

Location

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, Puy De Dome, 63003, France

Location

Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer

Bron, Rhone, 69500, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Hopital Henri Mondor

Paris, 94010, France

Location

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Klinikum der Universität München

Munich, Bavaria, 81377, Germany

Location

Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria, 81675, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

Paracelsus-Elena-Klinik Kassel

Kassel, Hesse, 34128, Germany

Location

Philipps University of Marburg

Marburg, Hesse, 35043, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Katholisches Klinikum Bochum gGmbH

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Universitaetsklinikum Duesseldorf AoeR

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Center Chaim Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

I.R.C.C.S. Neuromed

Diego, Centonze, 86077, Italy

Location

IRCCS-Institute of Neurological Sciences of Bologna

Bologna, 40139, Italy

Location

Azienda Ospedaliera Spedali

Brescia, 25123, Italy

Location

Azienda Ospedaliero Universitaria Policlinico 'Gaspare Rodolico - San Marco' (Presidio G. Rodolico)

Catania, 95123, Italy

Location

Ospedale Clinicizzato SS. Annu

Chieti, 66100, Italy

Location

Fondazione

Milan, 20122, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

AOU Luigi Vanvitelli

Napoli, 80138, Italy

Location

AO Universitaria Pisana

Pisa, 56126, Italy

Location

IRCCS San Raffaele Pisana

Roma, 00163, Italy

Location

Okinawa Prefectural Nanbu

Haeburu, Okinawa, 901-1105, Japan

Location

Tazuke-kofukai Medical Research Institute Kitano Hospital

Osaka, Osaka, 530-8480, Japan

Location

NHO Asahikawa Medical Center

Asahikawa-shi, 070-8644, Japan

Location

Himeji Central

Himeji-shi, 672-8043, Japan

Location

Sendai Nishitaga National Hospital

Sendai, 982-8555, Japan

Location

Juntendo University

Tokyo, 113-8431, Japan

Location

Brain Research Center Amsterdam

Amsterdam, 1081 GN, Netherlands

Location

Radboudumc

Nijmegen, 6525 GA, Netherlands

Location

Brain Research Center Zwolle B.V.

Zwolle, 8025 AZ, Netherlands

Location

Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K

Oświęcim, Katowice, 32-600, Poland

Location

NeuroProtect Sp. z o.o.

Warsaw, Masovian Voivodeship, 01-684, Poland

Location

Centrum Medyczne Neuromed

Bydgoszcz, 85-163, Poland

Location

Nzoz Novo-Med

Katowice, 40-650, Poland

Location

INSULA Centrum Badan Klinicznych

Warsaw, 02-699, Poland

Location

MD Clinic Praga

Warsaw, 03-505, Poland

Location

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, '08190, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Marques

Santanda, Santanda, 38003, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital de Cruces

Barakaldo, 48903, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Policlinica Gipuzkoa

Donostia / San Sebastian, 20014, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

University Hospitals Plymouth

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Re:Cognition Health Ltd (London)

London, Greater London, W1G 9RU, United Kingdom

Location

Charing Cross Hospital

London, Greater London, W6 8RF, United Kingdom

Location

The National Hospital for Neurology & Neurosurgery

London, Greater London, WC1N 3BG, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

NeuroClin Limited

Motherwell, Strathclyde, ML1 4UF, United Kingdom

Location

Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE4 5PL, United Kingdom

Location

Re:Cognition Health - Birmingham

Birmingham, West Midlands, B16 8LT, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Related Publications (1)

• 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 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.

  PMID: 40680102 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

DNL151

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 27, 2022
• Study Start: April 19, 2022
• Primary Completion: February 25, 2026
• Study Completion: March 9, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

PL (6); CA (5); US (33); IL (3); CN (4); FR (9); ES (11); GB (9); JP (6); IT (10); NL (3); DE (12); AU (2)