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Monoclonal Antibodies

BIIB122 for Parkinson's Disease (LIGHTHOUSE Trial)

Phase 3
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 96 to week 180
Awards & highlights
Pivotal Trial

Summary

This trial is studying a drug called BIIB122 in people with early-stage Parkinson's disease. The focus is on people with a specific genetic variant in their LRRK2 gene. The aim is to see if taking BIIB122 slows the worsening of PD more than placebo.

Eligible Conditions
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 96 to week 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 96 to week 180 for reporting.

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
Secondary study objectives
Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score at Week 96
Change From Baseline in MDS-UPDRS Parts II and III Combined Score at Week 96
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BIIB122 225 mgExperimental Treatment1 Intervention
Participants will receive 225 mg of BIIB122 tablets, orally, once daily (QD) for up to 180 weeks.
Group II: BIIB122-Matching PlaceboPlacebo Group1 Intervention
Participants will receive BIIB122-matching placebo tablets, orally, QD for up to 180 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIIB122
2024
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Denali Therapeutics Inc.Industry Sponsor
23 Previous Clinical Trials
1,923 Total Patients Enrolled
BiogenLead Sponsor
646 Previous Clinical Trials
467,506 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,892 Previous Clinical Trials
8,089,315 Total Patients Enrolled
~2 spots leftby Dec 2025
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