A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's Disease in Participants Between the Ages of 30 and 80

Parkinson Disease Clinical Trial

— LUMA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348785
• Other study ID #: 283PD201
• Secondary ID: 2021-004849-20
• Status: Recruiting
• Phase: Phase 2
• Start date: April 19, 2022
• Est. completion date: December 15, 2025

Study information

• Verified date: April 2024
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study:

• Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it.

• Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks.

• Certain medications for PD will be allowed at enrollment for a subset of participants.

• Participants will have to visit at 2-week intervals between baseline and week 12 and at 4-week intervals between week 12 and week 48 and at 12 week intervals between week 48 and week 144. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD.

To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: December 15, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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 (=)40 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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• BIIB122
Administered as specified in the treatment arm
• BIIB122-Matching Placebo
Administered as specified in the treatment arm

Locations

Country	Name	City	State
Austria	Medizinische Universität	Innsbruck	Tyrol
Austria	Klinik Ottakring	Vienna
Canada	University of Calgary	Calgary	Alberta
Canada	True North Clinical Research	Halifax	Nova Scotia
Canada	CHUM Centre de Recherche	Montreal	Quebec
Canada	Montreal Neurological Institute	Montreal	Quebec
Canada	Toronto Western Hospital	Toronto	Ontario
China	Beijing Hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Second Affiliated Hospital of Soochow University	Jiangsu	Jiangsu
France	Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer	Bron	Rhone
France	CHU Clermont Ferrand - Hopital Gabriel Montpied	Clermont Ferrand Cedex	Puy De Dome
France	CHU Nantes - Hopital Nord Laën	Loire-Atlantique
France	Hôpital de la Timone	Marseille	Bouches-du-Rhône
France	Hopital Gui de Chauliac	Montpellier	Herault
France	Groupe Hospitalier Pitie-Salpetriere	Paris
France	Hopital Henri Mondor	Paris
France	CHU Rennes - Hopital Pontchaillou	Rennes	Ille Et Vilaine
France	Hopital Purpan	Toulouse Cedex 09	Haute Garonne
Germany	Katholisches Klinikum Bochum gGmbH	Bochum	Nordrhein Westfalen
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden
Germany	Universitaetsklinikum Duesseldorf AoeR	Duesseldorf	Nordrhein Westfalen
Germany	Medizinische Hochschule Hannov	Hannover
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Paracelsus-Elena-Klinik Kassel	Kassel
Germany	University Hospital Schleswig	Luebeck
Germany	Universitätsklinikum Marburg	Marburg
Germany	Katholisches Klinikum Bochum	Muenchen	Bayern
Germany	Universitaetsklinikum Tuebinge	Tuebingen
Germany	Universitat Ulm	Ulm	Baden Wuerttemberg
Germany	Universitaetsklinikum Wuerzburg	Wuerzburg	Bayern
Israel	Rabin Medical Center	Petah Tikva
Israel	Center Chaim Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	IRCCS-Institute of Neurological Sciences of Bologna	Bologna
Italy	Azienda Ospedaliera Spedali	Brescia
Italy	U.O. Neurologia I	Catania
Italy	Ospedale Clinicizzato SS. Annu	Chieti
Italy	I.R.C.C.S. Neuromed	Diego	Centonze
Italy	Fondazione	Milano
Italy	Ospedale San Raffaele	Milano
Italy	AOU Luigi Vanvitelli	Napoli
Italy	AO Universitaria Pisana	Pisa
Italy	IRCCS San Raffaele Pisana	Roma
Japan	NHO Asahikawa Medical Center	Asahikawa-shi
Japan	Okinawa Prefectural Nanbu	Haeburu	Okinawa
Japan	Himeji Central	Himeji-shi
Japan	Sendai Nishitaga National Hospital	Sendai-shi
Japan	Juntendo University	Tokyo
Netherlands	Brain Research Center Amsterdam	Amsterdam
Netherlands	Radboudumc	Nijmegen
Netherlands	Brain Research Center Zwolle B.V.	Zwolle
Poland	Centrum Medyczne Neuromed	Bydgoszcz
Poland	Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K	Katowice
Poland	Nzoz Novo-Med	Katowice
Poland	Centrum Medyczne NeuroProtect	Warsaw	Mazowieckie
Poland	INSULA Centrum Badan Klinicznych	Warszawa
Poland	MD Clinic Praga	Warszawa
Spain	Complejo Hospitalario Universitario A Coruña	A Coruna
Spain	Hospital de Cruces	Barakaldo
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Policlinica Gipuzkoa	San Sebastian
Spain	Hospital General de Catalunya	Sant Cugat del Valles	Barcelona
Spain	Hospital Universitario Marques	Santanda
Spain	Hospital Universitario Virgen del Rocio	Sevilla
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Charing Cross Hospital	London	Greater London
United Kingdom	The National Hospital for Neurology & Neurosurgery	London	Greater London
United Kingdom	Glasgow Memory Clinic Ltd	Motherwell	Strathclyde
United Kingdom	Newcastle University	Newcastle upon Tyne	Tyne And Wear
United Kingdom	University Hospitals Plymouth	Plymouth	Devon
United Kingdom	Salford Royal NHS Foundation Trust	Salford	Greater Manchester
United States	University of Colorado	Aurora	Colorado
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston University Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Neurology Clinic, PC	Cordova	Tennessee
United States	Duke Movement Disorders Clinic	Durham	North Carolina
United States	CenExel Rocky Mountain Clinical Research	Englewood	Colorado
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Hawaii Pacific Neuroscience, LLC	Honolulu	Hawaii
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas
United States	Evergreen Hospital Medical Center	Kirkland	Washington
United States	Cedars Sinai	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Institute for Neurodegenerative Disorders (IND)	New Haven	Connecticut
United States	Mount Sinai Beth Israel	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	Adventist Health System/Sunbelt, Inc.	Orlando	Florida
United States	SC3 Research Group Inc.	Pasadena	California
United States	UPHS	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University Department of Neurology	Richmond	Virginia
United States	Central Texas Neurology Consultants	Round Rock	Texas
United States	University of California San Francisco (UCSF)	San Francisco	California
United States	Inland Northwest Research	Spokane	Washington
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	USF Health Byrd Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Denali Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Austria,  Canada,  China,  France,  Germany,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to Week 146
Secondary	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.	Up to a minimum of 48 weeks and a maximum of 144 weeks
Secondary	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.	From Baseline up to Week 48
Secondary	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.	Up to a minimum of 48 weeks and a maximum of 144 weeks
Secondary	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.	From Baseline up to Week 48

External Links

•   Click here to learn more about this trial, visit our study website.