BIIB122 (also known as DNL151) is a potent, selective, oral small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2) developed by Biogen in collaboration with Denali Therapeutics. The compound is designed to inhibit the kinase activity of LRRK2, which has been genetically linked to both familial and sporadic Parkinson's disease@biogen2022.
The LUMA trial (NCT05348785) is a Phase 2b multicenter study evaluating whether BIIB122 can slow disease progression in early-stage Parkinson's disease patients. This represents one of the most advanced LRRK2 inhibitor programs in clinical development for PD.
| Attribute | Value |
|---|---|
| Trial Name | LUMA |
| NCT Number | NCT05348785 |
| Phase | Phase 2b |
| Status | Active, not recruiting (verified October 2025) |
| Enrollment | 650 participants |
| Start Date | April 19, 2022 |
| Primary Completion | February 25, 2026 |
| Completion Date | March 9, 2026 |
| Arm | Intervention | Dose | Route | Frequency |
|---|---|---|---|---|
| Experimental | BIIB122 | 225 mg | Oral (tablet) | Once daily |
| Placebo Comparator | BIIB122 Matching Placebo | N/A | Oral (tablet) | Once daily |
LRRK2 (Leucine-Rich Repeat Kinase 2) is a large multi-domain protein with intrinsic kinase activity. Pathogenic variants in the LRRK2 gene, particularly the G2019S variant, are among the most common genetic causes of familial PD and also contribute to sporadic disease risk.
LRRK2 hyperactivity leads to:
BIIB122 is a highly selective ATP-competitive inhibitor of LRRK2 kinase activity. By inhibiting LRRK2, the drug aims to:
See LRRK2 Inhibitors in Parkinson's Disease for more on the therapeutic approach.
Primary Endpoint: Time to confirmed worsening in MDS-UPDRS Parts II and III combined score, sustained over 2 consecutive assessments, measured up to Week 144.
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) is the gold standard for assessing PD severity:
The trial is conducted at multiple sites across:
Individual participant data will be available through Vivli per Biogen's Clinical Trial Transparency and Data Sharing Policy.