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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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to a minimum of 48 weeks and a maximum of 144 weeks
Summary
This trial is testing a new drug called BIIB122 to see if it can slow down symptoms in people with early-stage Parkinson's disease. The drug works by blocking a protein that may cause the disease to get worse. Participants will take the drug for several years to see if it helps.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a rare form of Parkinson's or my Parkinson's may be caused by medication.
Select...
My memory and thinking test score was below 24.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to a minimum of 48 weeks and a maximum of 144 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to a minimum of 48 weeks and a maximum of 144 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreTrial 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
2024
Completed Phase 1
~110
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Parkinson's Disease (PD) primarily aim to manage symptoms and potentially offer neuroprotective benefits. Dopaminergic therapies, such as levodopa and dopamine agonists, work by replenishing or mimicking dopamine, a neurotransmitter deficient in PD patients, thereby improving motor function.
MAO B inhibitors, like rasagiline and selegiline, prevent the breakdown of dopamine, enhancing its availability in the brain. Neuroprotective agents, including those under investigation like BIIB122, target underlying disease mechanisms, such as oxidative stress, mitochondrial dysfunction, and protein aggregation, to slow disease progression.
These treatments are crucial for PD patients as they not only alleviate symptoms but also hold the potential to modify the disease course, improving long-term outcomes.
Advances in drug development for Parkinson's disease: present status.Neuropharmacological approach against MPTP (1-methyl-4-phenyl-1,2,3,6- tetrahydropyridine)-induced mouse model of Parkinson's disease.
Advances in drug development for Parkinson's disease: present status.Neuropharmacological approach against MPTP (1-methyl-4-phenyl-1,2,3,6- tetrahydropyridine)-induced mouse model of Parkinson's disease.
Find a Location
Who is running the clinical trial?
BiogenLead Sponsor
644 Previous Clinical Trials
466,729 Total Patients Enrolled
Denali Therapeutics Inc.Industry Sponsor
23 Previous Clinical Trials
1,290 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,864 Previous Clinical Trials
8,081,835 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Parkinson's is in the early to mid stages.I was diagnosed with Parkinson's disease within the last 2 years and was over 30 at diagnosis.I haven't had a major neurological issue like stroke or dementia in the last 5 years.I have a rare form of Parkinson's or my Parkinson's may be caused by medication.My memory and thinking test score was below 24.Your combined score for certain movement and daily living tests is 40 or lower when you are not taking your medication.
Research Study Groups:
This trial has the following groups:- Group 1: BIIB122 Matching Placebo
- Group 2: BIIB122 225 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT05348785 — Phase 2
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