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

Phase 1 & 2
Recruiting
Led By Horacio Kaufmann, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 40 to 75 years old, inclusive, at screening.
A diagnosis of PD or MSA, confirmed by the PI, as per the current Movement Disorders Society's criteria (Postuma 2015, Wenning 2022).
Must not have
Received blood and/or blood derivatives treatment within 3 months before Screening.
Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, week 133
Awards & highlights

Summary

This trial will test the safety of a potential vaccine for Parkinson's and Multiple System Atrophy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this is an early-phase trial primarily assessing safety and tolerability of UB-312 Injection (a synthetic peptide-based vaccine), detailed side effects are being determined but may include typical vaccine reactions such as soreness at injection site, fever, fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 75 years old.
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I have been diagnosed with Parkinson's disease or Multiple System Atrophy.
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My BMI is between 18 and 32, and I weigh at least 50 kg.
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I am a male willing to use contraception during the study and for 90 days after, and will not donate sperm.
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My mental function score is above 21.
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I am fully vaccinated and boosted for COVID-19 as per local guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received a blood transfusion or blood products within the last 3 months.
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I have been in a trial for treatments targeting aSyn with antibodies or vaccines.
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I do not have metal implants or fragments that prevent me from having an MRI.
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I haven't lost or donated more than 500 mL of blood in the last 3 months.
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I have not had brain surgery, device implantation in the brain, or stem cell studies.
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My only cancers in the past 5 years were skin cancers that were removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, week 133
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, week 133 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in CSF Levels of anti-aSyn Antibodies from First Injection
Change in Serum Levels of anti-aSyn Antibodies from First Injection

Trial Design

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Injection
2017
Completed Phase 4
~3710

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Multiple System Atrophy (MSA) often target the pathological accumulation of α-synuclein, a protein that aggregates and contributes to neurodegeneration. UB-312, a UBITh®-enhanced synthetic peptide-based vaccine, aims to provide active immunotherapy by inducing the body's immune system to produce antibodies against α-synuclein. This approach helps to reduce α-synuclein aggregation and its associated neurotoxic effects. For MSA patients, this is crucial as it addresses the underlying pathology of the disease, potentially slowing its progression and improving neurological function.
Azepine-Indole Alkaloids From <i>Psychotria nemorosa</i> Modulate 5-HT<sub>2<i>A</i></sub> Receptors and Prevent <i>in vivo</i> Protein Toxicity in Transgenic <i>Caenorhabditis elegans</i>.Targeting α-synuclein by PD03 AFFITOPE® and Anle138b rescues neurodegenerative pathology in a model of multiple system atrophy: clinical relevance.Nasal inoculation with α-synuclein aggregates evokes rigidity, locomotor deficits and immunity to such misfolded species as well as dopamine.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
848,110 Total Patients Enrolled
5 Trials studying Multiple System Atrophy
1,082 Patients Enrolled for Multiple System Atrophy
Horacio Kaufmann, MDPrincipal InvestigatorNYU Langone Health
9 Previous Clinical Trials
1,051 Total Patients Enrolled
1 Trials studying Multiple System Atrophy

Media Library

Placebo Injection Clinical Trial Eligibility Overview. Trial Name: NCT05634876 — Phase 1 & 2
Multiple System Atrophy Research Study Groups: Treatment First - PD, Delayed Start - PD, Delayed Start - MSA, Treatment First - MSA
Multiple System Atrophy Clinical Trial 2023: Placebo Injection Highlights & Side Effects. Trial Name: NCT05634876 — Phase 1 & 2
Placebo Injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT05634876 — Phase 1 & 2
~3 spots leftby May 2025