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Parkinson DiseasePhase 2LUMANCT05348785

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

A Phase 2 study testing BIIB122 in people with Parkinson Disease, run by Biogen at 113 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
BIIB122
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
113 sitesin 13 countries
Study dates
19 Apr 2022to 9 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

113 sites in 13 countries.

113 sites in 13 countries

United States33 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Massachusetts General Hospital

    Boston, Massachusetts, 02421

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018

  • Duke Movement Disorders Clinic

    Durham, North Carolina, 27705

  • CenExel Rocky Mountain Clinical Research

    Englewood, Colorado, 80113

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Hawaii Pacific Neuroscience, LLC

    Honolulu, Hawaii, 96817

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • Evergreen Hospital Medical Center

    Kirkland, Washington, 98034

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars Sinai

    Los Angeles, California, 90048

  • University of Miami

    Miami, Florida, 33136

  • Invicro

    New Haven, Connecticut, 06510

  • Mount Sinai Beth Israel

    New York, New York, 10003

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Adventist Health System/Sunbelt, Inc.

    Orlando, Florida, 32803

  • SC3 Research Group Inc.

    Pasadena, California, 91105

  • UPHS

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Virginia Commonwealth University Department of Neurology

    Richmond, Virginia, 23298

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • University of California San Francisco (UCSF)

    San Francisco, California, 94143

  • Inland Northwest Research

    Spokane, Washington, 99202

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • USF Health Byrd Institute

    Tampa, Florida, 33613

Other trials in United States

Germany12 sites

  • Katholisches Klinikum Bochum gGmbH

    Bochum, North Rhine-Westphalia, 44791

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Saxony, 01307

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, North Rhine-Westphalia, 40225

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Paracelsus-Elena-Klinik Kassel

    Kassel, Hesse, 34128

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Philipps University of Marburg

    Marburg, Hesse, 35043

  • Klinikum der Universität München

    Munich, Bavaria, 81377

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Universitaetsklinikum Wuerzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Spain11 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital de Cruces

    Barakaldo, 48903

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Policlinica Gipuzkoa

    Donostia / San Sebastian, 20014

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, '08190

  • Hospital Universitario Marques

    Santanda, Santanda, 38003

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Italy10 sites

  • IRCCS-Institute of Neurological Sciences of Bologna

    Bologna, 40139

  • Azienda Ospedaliera Spedali

    Brescia, 25123

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

    Catania, 95123

  • Ospedale Clinicizzato SS. Annu

    Chieti, 66100

  • I.R.C.C.S. Neuromed

    Diego, Centonze, 86077

  • Fondazione

    Milan, 20122

  • Ospedale San Raffaele

    Milan, 20132

  • AOU Luigi Vanvitelli

    Naples, 80138

  • AO Universitaria Pisana

    Pisa, 56126

  • IRCCS San Raffaele Pisana

    Roma, 00163

Other trials in Italy

France9 sites

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

    Bron, Rhone, 69500

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, Puy De Dome, 63003

  • CHU Nantes - Hopital Nord Laën

    Loire-Atlantique, Loire-Atlantique, 44093

  • Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13005

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • Hopital Henri Mondor

    Paris, 94010

  • CHU Rennes - Hopital Pontchaillou

    Rennes, Ille Et Vilaine, 35033

  • Hopital Purpan

    Toulouse, Haute Garonne, 31059

Other trials in France

United Kingdom9 sites

  • Re:Cognition Health - Birmingham

    Birmingham, West Midlands, B16 8LT

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Re:Cognition Health Ltd (London)

    London, Greater London, W1G 9RU

  • Charing Cross Hospital

    London, Greater London, W6 8RF

  • The National Hospital for Neurology & Neurosurgery

    London, Greater London, WC1N 3BG

  • NeuroClin Limited

    Motherwell, Strathclyde, ML1 4UF

  • Newcastle University

    Newcastle upon Tyne, Tyne and Wear, NE4 5PL

  • University Hospitals Plymouth

    Plymouth, Devon, PL6 8DH

  • Salford Royal NHS Foundation Trust

    Salford, Greater Manchester, M6 8HD

Other trials in United Kingdom

Japan6 sites

  • NHO Asahikawa Medical Center

    Asahikawa-shi, 070-8644

  • Okinawa Prefectural Nanbu

    Haeburu, Okinawa, 901-1105

  • Himeji Central

    Himeji-shi, 672-8043

  • Tazuke-kofukai Medical Research Institute Kitano Hospital

    Osaka, Osaka, 530-8480

  • Sendai Nishitaga National Hospital

    Sendai, 982-8555

  • Juntendo University

    Tokyo, 113-8431

Other trials in Japan

Poland6 sites

  • Centrum Medyczne Neuromed

    Bydgoszcz, 85-163

  • Nzoz Novo-Med

    Katowice, 40-650

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

    Oświęcim, Katowice, 32-600

  • NeuroProtect Sp. z o.o.

    Warsaw, Masovian Voivodeship, 01-684

  • INSULA Centrum Badan Klinicznych

    Warsaw, 02-699

  • MD Clinic Praga

    Warsaw, 03-505

Other trials in Poland

Canada5 sites

  • University of Calgary

    Calgary, Alberta, T2N 1N4

  • True North Clinical Research

    Halifax, Nova Scotia, B3S 1M7

  • CHUM Centre de Recherche

    Montreal, Quebec, H2L 4M1

  • Montreal Neurological Institute

    Montreal, Quebec, H3A 2B4

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

China4 sites

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

Other trials in China

Israel3 sites

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Center Chaim Sheba Medical Center

    Ramat Gan, 5262000

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Netherlands3 sites

  • Brain Research Center Amsterdam

    Amsterdam, 1081 GN

  • Radboudumc

    Nijmegen, 6525 GA

  • Brain Research Center Zwolle B.V.

    Zwolle, 8025 AZ

Other trials in Netherlands

Austria2 sites

  • Medizinische Universität

    Innsbruck, Tyrol, 6020

  • Klinik Ottakring

    Vienna, 1160

Other trials in Austria

About this study

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

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:

Read more
  • 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.
Read the 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.

Being tested
BIIB122, BIIB122-Matching Placebo
Keywords
Early-stage Parkinson Disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB122Drug

    Also called DNL151

    Administered as specified in the treatment arm

  • BIIB122-Matching PlaceboDrug

    Administered as specified in the treatment arm

Study groups in NCT05348785
Study groupRoleWhat they receive
BIIB122 225 mgExperimentalParticipants 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.
Receives: Drug: BIIB122
BIIB122 Matching PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: BIIB122-Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to Week 144

Secondary outcomes (5)

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

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.

    Measured: Up to Week 144

  2. Time to Confirmed Worsening in MDS-UPDRS Part II 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. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD.

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

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

    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. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD. 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 Parts II and III combined score equals the sum of Part II and III (Range 0-184). A higher score indicates more severe symptoms of PD.

    Measured: From Baseline up to Week 48

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

    Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. The mSE-ADL scale reflects the speed, ease, and independence with which an individual performs daily activities or personal chores with 100% indicating total independence, falling to 0%, which indicates a state of complete dependence. The individual is asked to rate his or her function using an 11-point scale (10% increments), from 100% (completely independent; able to do all chores without slowness, difficulty, or impairment; essentially normal; unaware of any difficulty) to 0% (vegetative functions such as swallowing, bladder and bowels are not functioning; bedridden). The lower the score, the worse the functional status.

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

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

    MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assesses non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contains 6 questions and is assessed by the examiner (Range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which are to be completed by the participant (Range 0-28). 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 total score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicates more severe symptoms of PD.

    Measured: From Baseline up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2022
  2. Study start19 Apr 2022
  3. Primary completion9 Mar 2026
  4. Study completion9 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05348785
Sponsor's protocol ID
283PD201
Other IDs
2023-505645-12, 2023
Acronym
LUMA
Status last verified
Jun 2026
First submitted
4 Apr 2022
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Publications

  • 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.

    PubMed 40680102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIIB122 in people with Parkinson Disease, run by Biogen at 113 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Germany, Spain, Italy, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to Week 144). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05348785, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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