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A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson’s Disease (LRRK2-PD)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513384-15-00
Acronym
DNLI-C-0009
Enrollment
27
Registered
2024-11-25
Start date
2025-02-13
Completion date
Unknown
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson’s disease

Brief summary

Incidence of TEAEs and SAEs with BIIB122 compared with placebo over the 12-week double-blind period

Detailed description

Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12, Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12

Interventions

DRUGPlacebo to BIIB122

Sponsors

Denali Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of TEAEs and SAEs with BIIB122 compared with placebo over the 12-week double-blind period

Secondary

MeasureTime frame
Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12, Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026