BIIB122 for Early-Stage Parkinson's Disease

(LUMA Trial)

Not currently recruiting at 147 trial locations

Overseen By Anthony Emanuele

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biogen

Disqualifiers: Stroke, Dementia, Seizure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 29

Duration: 48 to 144 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new treatment, BIIB122 (also known as DNL151), can slow the progression of early-stage Parkinson's disease symptoms. Participants will receive either BIIB122 or a placebo (a look-alike pill with no active ingredient) to compare the treatment's effect on symptom worsening over time. The study targets individuals diagnosed with Parkinson's disease within the last two years who experience early symptoms impacting daily activities. Researchers will monitor participants for any unwanted side effects and track symptoms using specific scales. Participants will take the medication daily for up to three years and attend regular check-ups to assess progress. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that BIIB122 is likely to be safe for humans?

Research has shown that BIIB122 is generally safe and well-tolerated in earlier studies. In tests with healthy volunteers, BIIB122, which targets a protein linked to Parkinson's disease, demonstrated a good safety record. Participants did not experience major health problems, and most side effects were mild. This suggests that BIIB122 could be a safe option for those considering a clinical trial. However, treatments can affect individuals differently. Participants should discuss potential risks and benefits with their doctor before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

Most treatments for Parkinson's disease, like levodopa and dopamine agonists, aim to manage symptoms by boosting dopamine levels. However, BIIB122 is unique because it targets a different mechanism, potentially slowing disease progression by inhibiting the LRRK2 protein, which is linked to the genetic aspects of Parkinson's. Researchers are excited about BIIB122 because it offers a novel approach that could modify the disease course, rather than just alleviating symptoms. This innovative strategy could lead to more effective long-term management of Parkinson's disease, providing hope for patients seeking alternatives to current therapies.

What evidence suggests that BIIB122 might be an effective treatment for early-stage Parkinson's disease?

Research has shown that BIIB122, which participants in this trial may receive, targets a protein called LRRK2, believed to be involved in Parkinson's disease (PD). Studies suggest that blocking LRRK2 might help slow the worsening of PD symptoms. Early results in healthy individuals indicate that BIIB122 can successfully block LRRK2, making it a promising treatment for early-stage PD. Although more information is needed, the mechanism of BIIB122 offers hope that it could help slow the progression of PD symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

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.

Inclusion 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.

MDS-UPDRS Parts II and III (in OFF state) combined score ≤40 at screening

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BIIB122 or placebo tablets by mouth once daily

48 to 144 weeks

Up to 29 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIIB122

Trial Overview 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.

How Is the Trial Designed?

Group I: BIIB122 225 mg Experimental Treatment 1 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 Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Denali Therapeutics Inc.

Industry Sponsor

Trials

24

Recruited

1,900+

Published Research Related to This Trial

In a study involving eight parkinsonian monkeys, co-administration of the NMDA receptor antagonist CI-1041 with L-dopa significantly reduced the development of L-dopa-induced dyskinesias (LID), with only one monkey showing mild symptoms compared to all four in the L-dopa alone group.

The effectiveness of L-dopa in alleviating Parkinson's symptoms remained similar in both treatment groups, indicating that CI-1041 can potentially manage LID without compromising the therapeutic benefits of L-dopa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a selective glutamate antagonist on L-dopa-induced dyskinesias in drug-naive parkinsonian monkeys. Hadj Tahar, A., Grégoire, L., Darré, A., et al.[2014]

A variety of new pharmacological treatments for Parkinson's disease (PD) are being developed, including modified forms of L-dopa and enzyme inhibitors, which target different aspects of the disease.

In addition to dopaminergic treatments, non-dopaminergic options and neuroprotective agents are emerging, aiming to improve symptoms and potentially halt disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drugs in development for Parkinson's disease. Johnston, TH., Brotchie, JM.[2007]

Current dopamine replacement therapies can alleviate motor symptoms of Parkinson's disease, but there is a significant need for improved treatments that also address non-motor symptoms and provide neuroprotection.

Research is focusing on identifying promising biological targets and therapeutic agents, with an emphasis on understanding genetic factors and enhancing the translation of findings from animal models to human clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Priorities in Parkinson's disease research. Meissner, WG., Frasier, M., Gasser, T., et al.[2022]

A new drug has demonstrated potential in delaying the onset of Parkinsonism, which is a significant advancement for patients at risk of developing this condition.

The findings suggest that this drug could improve the quality of life for individuals by postponing the debilitating symptoms associated with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delaying the onset of parkinson's disease. [2016]

COMT inhibitors have been shown to effectively prolong the action of levodopa in Parkinson's disease patients experiencing the 'wearing off' phenomenon, providing a new treatment option for those with fluctuating responses to standard therapy.

Clozapine not only alleviates levodopa-induced psychosis but also helps reduce tremors and dyskinesias, highlighting its dual role in managing symptoms of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New medical and surgical treatments for Parkinson's disease. Klockgether, T., Löschmann, PA., Wüllner, U.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05348785

NCT05348785 | A Study to Learn About the Safety of ... The main objective of the study is to learn about the effect BIIB122 has on slowing down the worsening of PD symptoms.

2. investors.biogen.com investors.biogen.com/news-releases/news-release-details/statement-biogen-provides-update-parkinsons-disease-clinical

Statement: Biogen Provides Update on Parkinson's ... Biogen announced plans to revise the clinical development program for BIIB122, a small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2).

3. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29297

LRRK2 Inhibition by BIIB122 in Healthy Participants and ... Leucine-rich repeat kinase 2 (LRRK2) inhibition is a promising therapeutic approach for the treatment of Parkinson's disease (PD).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05418673

NCT05418673 | A Study to Assess if BIIB122 Tablets Are ... A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants ...

5. neurologylive.com neurologylive.com/view/biogen-denali-terminate-phase-3-lighthouse-study-biib122-lrrk2-parkinson-disease

Biogen and Denali Terminate Phase 3 LIGHTHOUSE ... Biogen and Denali have announced that they are discontinuing a portion of the clinical development program for BIIB122 (also known as DNL151), an ...