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Monoclonal Antibodies

BIIB122 for Early-Stage Parkinson's Disease (LUMA Trial)

Phase 2
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Modified Hoehn and Yahr scale stages 1 to 2 (in OFF state), inclusive, at screening
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to a minimum of 48 weeks and a maximum of 144 weeks
Awards & highlights

LUMA Trial Summary

This trial will help researchers learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The drug is taken 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks. The goal is to see if the drug slows the worsening of symptoms more than a placebo.

Who is the study for?
This trial is for people aged 30-80 with early-stage Parkinson's disease, diagnosed within the last two years. Participants should have mild symptoms (stages 1 to 2 on a specific scale) and score ≤40 on a PD symptom questionnaire. They can't join if they have other significant neurological issues, atypical parkinsonism, drug-induced parkinsonism, or cognitive impairment as indicated by a MoCA score <24.Check my eligibility
What is being tested?
The study tests BIIB122 tablets against placebo to see if it slows down symptom worsening in early Parkinson's over a period of up to three years. Patients will take either the drug or placebo daily and attend clinic visits every three months. The effectiveness will be measured using the MDS-UPDRS questionnaire assessing PD symptoms' impact on daily life.See study design
What are the potential side effects?
While specific side effects of BIIB122 are not listed here, clinical trials typically monitor for any adverse reactions ranging from mild (like headaches or nausea) to severe (such as allergic reactions). Safety information will be gathered throughout the study.

LUMA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Parkinson's is in the early to mid stages.
Select...
I was diagnosed with Parkinson's disease within the last 2 years and was over 30 at diagnosis.

LUMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to a minimum of 48 weeks and a maximum of 144 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to a minimum of 48 weeks and a maximum of 144 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score
Change From Baseline in MDS-UPDRS Parts II and III Combined Score
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
+2 more

LUMA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BIIB122 225 mgExperimental Treatment1 Intervention
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.
Group II: BIIB122 Matching PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIIB122
2022
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
466,717 Total Patients Enrolled
Denali Therapeutics Inc.Industry Sponsor
22 Previous Clinical Trials
1,227 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,224 Total Patients Enrolled

Media Library

BIIB122 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05348785 — Phase 2
Parkinson's Disease Research Study Groups: BIIB122 Matching Placebo, BIIB122 225 mg
Parkinson's Disease Clinical Trial 2023: BIIB122 Highlights & Side Effects. Trial Name: NCT05348785 — Phase 2
BIIB122 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05348785 — Phase 2
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT05348785 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of risks does BIIB122 pose to patients?

"There is some clinical data suggesting that BIIB122 is safe, but none yet affirming its efficacy; thus, it received a score of 2."

Answered by AI

How many medical facilities are participating in this clinical trial?

"There are a total of 8 clinical trial sites across the United States, including locations in Spokane, Honolulu and Boca Raton. If you enroll in this study, it is best to select the site closest to your home to reduce travel-related inconvenience."

Answered by AI

Are new patients being accepted into this trial at this time?

"The information available on clinicaltrials.gov tells us that this research is actively looking for subjects. This specific trial was first advertised on 4/19/2022 and has since been updated on 10/10/2022. The study wants to enroll 640 individuals from 8 different locations."

Answered by AI

What are the requirements to take part in this experiment?

"This ongoing study is seeking 640 individuals with a history of parkinson disease. The patients must be aged between 30 and 80, and meet the following additional requirements: A clinical diagnosis of PD that falls within the Movement Disorder Society Clinical Diagnostic Criteria (MDS-UPDRS), a Modified Hoehn and Yahr scale stage of 1 to 2, genetic test results verifying the absence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant."

Answered by AI

Will this trial consider patients who are not yet adults?

"The target age-range for participants in this study are individuals who are over 30 but younger than 80 years old."

Answered by AI

How many research subjects are included in this clinical trial?

"640 patients that meet the study's requirements need to be enrolled for the trial to proceed as planned. The clinical research will take place at Biogen locations such as the Research Site in Spokane, Washington and Hawaii Pacific Neuroscience, LLC in Honolulu, Hawaii."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
California
How old are they?
18 - 65
What site did they apply to?
CenExel Rocky Mountain Movement Disorders Center
SC3 Research Group Inc.
University of California San Francisco (UCSF)
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

I’m slowly getting worse and current medications suck. Had a DATscan and my neurologist said I had the beginning stages of Parkinson’s. He prescribed Carbidopa Levidopa and found it made me sick. He discontinued my usage over four months ago and now do not talke any medication.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long our the visits and how often?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05348785.
All > Parkinsons Disease > Honolulu
~283 spots leftby Dec 2025
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