Parkinson DiseasePhase 2NCT06602193
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
A Phase 2 study testing BIIB122 225 mg in people with Parkinson Disease, run by Denali Therapeutics Inc. at 20 sites in 4 countries.
Trial summary
This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- BIIB122 225 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 24 Oct 2024to 28 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years
- For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years
- Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.
- Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.
Who cannot join
- Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit.
- Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
- Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201).
- Have previously participated or are currently participating in a gene therapy study for PD.
- Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy).
- Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability).
Show all 9Show fewer
- Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature
- Have abnormal PFT results at screening
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States7 sites
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida, 33486
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Evergreen Health Laboratory
Kirkland, Washington, 98034
Cedars-Sinai Department of Neurology
Los Angeles, California, 90048
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
New York, New York, 10003
University of California San Francisco
San Francisco, California, 94158
Inland Northwest Research
Spokane, Washington, 99202
Spain7 sites
Hospital Clinic de Barcelona
Barcelona
Hospital Universitari General de Catalunya
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario Donostia
Donostia / San Sebastian
Universitary Hospital La Princesa
Madrid
IDIVAL/University Hospital Marques de Valdecilla
Santander
Hospital Universitario Virgen del Rocio
Seville
Germany3 sites
Technische Universität Dresden
Dresden
University of Lübeck
Lübeck
University Hospital Tübingen
Tübingen
Israel3 sites
Rabin Medical Center
Petah Tikva
Movement Disorders Institute, Sheba Medical Center
Ramat Gan
Tel Aviv Medical Center
Tel Aviv
About this study
Official title: 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)
This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.
- Conditions
- Parkinson Disease
- Being tested
- BIIB122 225 mg, BIIB122-Matching Placebo
- Keywords
- LRRK2, Movement Disorders
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB122 225 mgDrug
Also called DNL151
Administered as specified in the treatment arm
BIIB122-Matching PlaceboOther
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| BIIB122 225 mg | Experimental | Oral 225 mg dose, once daily (QD) Receives: Drug: BIIB122 225 mg |
| BIIB122 Matching Placebo | Placebo comparator | Oral BIIB122 matching placebo, once daily (QD) Receives: Other: BIIB122-Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period
Measured: 12 weeks
Secondary outcomes (2)
Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12
Measured: 12 weeks
Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Oct 2024
- Primary completionMar 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Denali Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Danna Jennings, MD, Study director, Denali Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602193
- Sponsor's protocol ID
- DNLI-C-0009
- Status last verified
- May 2026
- First submitted
- 16 Sep 2024
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06602193
- Acronym / sponsor ID
- DNLI-C-0009
- Conditions
- Parkinson Disease
- Keywords
- LRRK2, Movement Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Denali Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIB122 225 mg | Experimental | Drug: BIIB122 225 mgOral 225 mg dose, once daily (QD) |
| BIIB122 Matching Placebo | Placebo comparator | Other: BIIB122-Matching PlaceboOral BIIB122 matching placebo, once daily (QD) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years
- For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years
- Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.
- Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.
Key exclusion criteria (9 listed)
- Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit.
- Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
- Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201).
- Have previously participated or are currently participating in a gene therapy study for PD.
- Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIIB122 225 mgAlso: DNL151Administered as specified in the treatment arm | Drug | BIIB122 225 mg |
| BIIB122-Matching PlaceboAdministered as specified in the treatment arm | Other | BIIB122 Matching Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period
Time frame: 12 weeks
2 secondary outcomes
Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12
Time frame: 12 weeks
Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danna Jennings, MD study director
Denali Therapeutics
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB122 225 mg in people with Parkinson Disease, run by Denali Therapeutics Inc. at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Spain, Germany, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.