8 Participants Needed

UB-312 Vaccine for Parkinson's & Multiple System Atrophy

HK
Overseen By
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: NYU Langone Health
Must be taking: Antiparkinsonian medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants have stable treatment of permitted antiparkinsonian medications for at least 30 days before the first study drug administration, or 60 days for MAO-B inhibitors, and remain stable throughout the study. Some medications are prohibited, so you may need to adjust your current medications based on the trial's requirements.

What data supports the effectiveness of the UB-312 vaccine for Parkinson's and Multiple System Atrophy?

Research suggests that UB-312, a vaccine targeting alpha-synuclein (a protein involved in Parkinson's disease), may help by inducing antibodies against harmful forms of this protein, potentially offering a new way to treat conditions like Parkinson's and Multiple System Atrophy.12345

Is the UB-312 vaccine safe for humans?

A first-in-human study of UB-312, a vaccine targeting alpha-synuclein, suggests it is generally safe, though specific safety data from this study is not detailed. Another study on similar vaccines for multiple system atrophy reported mild to moderate side effects, mostly injection-site reactions, indicating a good safety profile.34678

How is the UB-312 treatment different from other treatments for Parkinson's and Multiple System Atrophy?

UB-312 is a vaccine that targets alpha-synuclein, a protein involved in Parkinson's and Multiple System Atrophy, aiming to prevent its harmful accumulation in the brain and gut. This approach is unique because it uses the body's immune system to produce antibodies against the toxic forms of alpha-synuclein, potentially modifying the disease process rather than just alleviating symptoms.34679

What is the purpose of this trial?

This trial tests a new vaccine called UB-312, which aims to help patients with MSA and PD by teaching their immune systems to attack harmful brain proteins.

Research Team

HK

Horacio Kaufmann, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults aged 40-75 with Parkinson's Disease or Multiple System Atrophy, confirmed by specific criteria. Participants must have a certain cognitive score, be within a specified weight range, and agree to use contraception if of childbearing potential. They should not have had recent investigational drug use, significant allergies, autoimmune disorders, or conditions that could interfere with the study.

Inclusion Criteria

I am between 40 and 75 years old.
I have been diagnosed with Parkinson's disease or Multiple System Atrophy.
Expected to be able to undergo all study procedures.
See 7 more

Exclusion Criteria

Receipt of an investigational product or device, or participation in a drug research study within 90 days before baseline at V1.
Participants who are currently breastfeeding or intend to breastfeed during the study. Participants should not be willing to get pregnant and breastfeed till 24 weeks after the last injection.
You have had problems with drug or alcohol addiction in the past 2 years.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active treatment and placebo injections over a period of 97 weeks

97 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Details

Interventions

  • Placebo Injection
  • UB-312 Injection
Trial Overview The trial tests UB-312 Injection against a placebo in patients with synucleinopathies like Parkinson's Disease and Multiple System Atrophy. UB-312 is an experimental vaccine aimed at providing active immunotherapy for these conditions. The study will assess safety, tolerability, and immune response.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Treatment First - PDExperimental Treatment2 Interventions
Includes participants with PD only. Patients in the treatment-first arm will receive active treatment at weeks 1, 5, 13, 25, 37, 49, 73, and 97; and placebo doses at weeks 17, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose. All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).
Group II: Treatment First - MSAExperimental Treatment2 Interventions
Includes participants with MSA only. Patients in the treatment-first arm will receive active treatment at weeks 1, 5, 13, 25, 37, 49, 73, and 97; and placebo doses at weeks 17, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose. All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).
Group III: Delayed Start - PDExperimental Treatment2 Interventions
Includes participants with PD only. Patients in the delayed-start arm will receive placebo injections at weeks 1, 5, 73, and 97; and active treatment at weeks 13, 17, 25, 37, 49, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose. All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).
Group IV: Delayed Start - MSAExperimental Treatment2 Interventions
Includes participants with MSA only Patients in the delayed-start arm will receive placebo injections at weeks 1, 5, 73, and 97; and active treatment at weeks 13, 17, 25, 37, 49, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose. All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Findings from Research

Intrathecal baclofen (ITB) therapy showed positive effects on muscle tone and function in three patients with multiple system atrophy (MSA), as evidenced by improvements in the modified Ashworth scale.
None of the patients experienced expected progression in disability or ambulation, suggesting that ITB may help maintain quality of life and delay disease progression in MSA, warranting further research into its benefits.
Intrathecal baclofen therapy slows progressive disability in multiple system atrophy.Madan, A., Schiess, MC.[2022]
In a placebo-controlled trial involving 10 patients with probable multiple system atrophy (MSA), riluzole (100 mg twice daily) was found to be well tolerated but did not show significant anti-Parkinsonian effects based on the Unified Parkinson's Disease Rating Scale (UPDRS).
The results suggest that riluzole is unlikely to provide clinically meaningful benefits for Parkinsonian symptoms in MSA, prompting further investigation into its potential disease-modifying effects in ongoing trials.
Placebo-controlled trial of riluzole in multiple system atrophy.Seppi, K., Peralta, C., Diem-Zangerl, A., et al.[2015]
In a study of 14 patients with multiple system atrophy parkinsonism (MSA-P), high-dose intravenous amantadine for 5 days led to clinical improvement in 71.4% of subjects, with a significant decrease in disease severity as measured by the Unified Multiple System Atrophy Rating Scale (UMSARS).
The treatment was generally safe, with only mild and transient adverse effects reported, although one patient experienced acute psychosis, which resolved after stopping the treatment.
Efficacy of Parenteral Amantadine Therapy in the Treatment of Multiple System Atrophy With Predominant Parkinsonism.Friedberg, A., Erikh, I., Nassar, M., et al.[2018]

References

Intrathecal baclofen therapy slows progressive disability in multiple system atrophy. [2022]
Placebo-controlled trial of riluzole in multiple system atrophy. [2015]
A Randomized First-in-Human Study With UB-312, a UBITh® α-Synuclein Peptide Vaccine. [2022]
Active immunization against alpha-synuclein ameliorates the degenerative pathology and prevents demyelination in a model of multiple system atrophy. [2018]
Efficacy of Parenteral Amantadine Therapy in the Treatment of Multiple System Atrophy With Predominant Parkinsonism. [2018]
Immunisation with UB-312 in the Thy1SNCA mouse prevents motor performance deficits and oligomeric α-synuclein accumulation in the brain and gut. [2022]
A Phase 1 Randomized Trial of Specific Active α-Synuclein Immunotherapies PD01A and PD03A in Multiple System Atrophy. [2022]
Novel antibodies detect additional α-synuclein pathology in synucleinopathies: potential development for immunotherapy. [2023]
Long-Term Clinical Efficacy of Human Umbilical Cord Blood Mononuclear Cell Transplantation by Lateral Atlanto-Occipital Space Puncture (Gong's Puncture) for the Treatment of Multiple System Atrophy. [2022]
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