Multiple System AtrophyPhase 1NCT05634876
UB-312 in Patients With Synucleinopathies
A Phase 1 study testing UB-312 Injection in people with Multiple System Atrophy and Parkinson Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a Phase 1b study to determine the safety, tolerability, and immunogenicity of UB-312 in participants with multiple system atrophy (MSA), and in participants with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Multiple System Atrophy, Parkinson Disease
- What is being tested?
- UB-312 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 11 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent is signed and dated by the participant.
- Male or female aged 40 to 75 years old, inclusive, at screening.
- Participants must have a body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
- Expected to be able to undergo all study procedures.
- Women must be of non-childbearing potential (postmenopausal for at least 12 months before screening or surgically sterile) or, if of childbearing potential, must be using medically acceptable contraceptive measures throughout the study and for at least 24 weeks after their last dose of study treatment.
- Male participants and their partners of childbearing potential must commit to using medically acceptable contraception for the study duration and at least 90 days after their last dose of study treatment. Men must refrain from donating sperm during this same period. The female partners should use a medically acceptable contraception method, and these contraceptive measures should be used throughout the study and for at least 90 days after their last dose of study treatment.
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- A diagnosis of PD or MSA, confirmed by the PI, as per the current Movement Disorders Society's criteria (Postuma 2015, Wenning 2022).
- Stable treatment of permitted antiparkinsonian medications from 30 days before first study drug administration or 60 days for MAO-B inhibitors and expected to remain stable throughout the study unless required adjustment or initiation per the investigator's judgment; except for short-acting rescue medications, which are allowed (see Section 7.1 for the list of permitted medications).
- Eligible participants must be fully vaccinated against COVID-19 according to local guidelines. Participants also must have received a COVID-19 booster vaccination, and the interval between booster vaccination and sample collection for inflammatory markers at Screening should be at least seven days.
- Subjects with a MOCA score > 21 at screening and throughout enrollment.
Who cannot join
- Clinically significant abnormalities, as judged by the investigator, in test results (including hepatic and renal panels, complete blood count, chemistry panel, a level of anti-cyclic citrullinated peptide (anti-CCP) above the upper limit of normal (ULN) at Screening, positive antinuclear antibodies (ANA), except judged to be clinically irrelevant by the investigator, urinalysis, ECG and imaging), or vital signs. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant.
- History of medical, neurological, or psychiatric conditions, which in the opinion of the investigator, may compromise the participant's safety or scientific value of the study, posing an unacceptable risk to the participant or interfering with the participant's ability to comply with the study procedures or abide by study restrictions.
- History of Substance Use Disorder within the past 2 years before screening (Diagnostic and Statistical Manual of Mental Disorders-5 [DSM-V] criteria).
- Acute or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) at Screening or any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 infection, or cytotoxic therapy in the previous 5 years.
- History or evidence of an autoimmune disorder (e.g. Sjogren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.), which in the opinion of the investigator may compromise the patient's safety or scientific value of the study, posing an unacceptable risk to the participant.
- History of anergy.
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- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or vaccine, or multiple drug allergies (non-active hay fever is acceptable).
- History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) which has not been in remission for at least 5 years before Screening.
- Contraindications to MRI, including but not limited to the presence of metal devices or implants (e.g., pacemaker, vascular- or heart-valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes.
- Receipt of an investigational product or device, or participation in a drug research study within 90 days before baseline at V1.
- Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn.
- Underwent any procedures/studies involving intracranial surgery, implantation of a device into the brain, or stem cell study.
- Pregnancy, confirmed by a positive pregnancy test.
- 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.
- Use of any prohibited medications within 30 days or 5 half-lives (whichever is greater) before Screening till the end-of-study; also excluded administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of Screening (including prednisone or equivalent, greater than or equal to 0.5 mg/kg/day; except Intranasal, inhalation, and topical steroids are allowed).
- Immunization or vaccination will be prohibited within 2 weeks before Screening. Regular vaccinations scheduled for preventative illnesses (e.g., flu, COVID-19) required as per local guidelines after Screening until Week 16 need to be discussed with the Investigator and approved on a case-by-case basis. Vaccinations after Week 16 until the end of the study are allowed if not within 2 weeks of (e.g., 2 weeks before and 2 weeks after) each post-baseline IP administration.
- Any contraindication to undergoing a lumbar puncture (e.g., anatomical variations or local skin infection), as judged by the investigator.
- Loss or donation of blood over 500 mL within three months before Screening or intention to donate blood or blood products for transfusion during the study and 13 months after their last dose.
- Received blood and/or blood derivatives treatment within 3 months before Screening.
- Positive test result for SARS-CoV-2 infection (if test performed according to local guidelines) in the 2 weeks before the first dose.
- Other known or suspected causes of Parkinsonism other than idiopathic PD or MSA, including but not limited to, progressive supranuclear gaze palsy, drug- or toxin-induced parkinsonism, essential tremor, primary dystonia, or vascular parkinsonism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Clinical Trial of UB-312 in Patients With Synucleinopathies
This is a Phase 1b study to determine the safety, tolerability, and immunogenicity of UB-312 in participants with multiple system atrophy (MSA), and in participants with Parkinson's disease (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy option for treating synucleinopathies including the most prevalent form, PD; and the most rapidly progressive form, MSA.
- Conditions
- Multiple System Atrophy, Parkinson Disease
- Being tested
- UB-312 Injection, Placebo Injection
- Medical subject headings
- Multiple System Atrophy, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-312 InjectionBiological
UB-312, provided by Vaxxinity, contains 300 μg of p4573kb Drug Substance (synthetic peptide immunogen) formulated with CpG1 and Adju-Phos as a white, opaque, liquid suspension. The biological will be injected intramuscularly. The injection site will be the deltoid muscle.
Placebo InjectionBiological
Placebo will be injected intramuscularly. The injection site will be the deltoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| Treatment First - MSA | Experimental | 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). Receives: Biological: UB-312 Injection; Biological: Placebo Injection |
| Delayed Start - MSA | Experimental | 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). Receives: Biological: UB-312 Injection; Biological: Placebo Injection |
| Treatment First - PD | Experimental | 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). Receives: Biological: UB-312 Injection; Biological: Placebo Injection |
| Delayed Start - PD | Experimental | 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). Receives: Biological: UB-312 Injection; Biological: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Levels of anti-aSyn Antibodies from First Injection
Derived from participant serum samples and calculated using a validated enzyme immunoassay.
Measured: Day 1, Week 133
Change in CSF Levels of anti-aSyn Antibodies from First Injection
Derived from participant cerebrospinal fluid (CSF) samples and calculated using a validated enzyme immunoassay.
Measured: Day 1, Week 133
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start31 May 2023
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horacio Kaufmann, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634876
- Sponsor's protocol ID
- 22-00631
- Status last verified
- Mar 2026
- First submitted
- 23 Nov 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[Horacio.kaufmann@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Clinical Trial of UB-312 in Patients With Synucleinopathies
- ClinicalTrials.gov ID
- NCT05634876
- Acronym / sponsor ID
- 22-00631
- Conditions
- Multiple System Atrophy, Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 2 Dec 2022 (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 is a Phase 1b study to determine the safety, tolerability, and immunogenicity of UB-312 in participants with multiple system atrophy (MSA), and in participants with Parkinson's disease (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy option for treating synucleinopathies including the most prevalent form, PD; and the most rapidly progressive form, MSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment First - MSA | Experimental | Biological: UB-312 Injection, Biological: Placebo InjectionIncludes 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). |
| Delayed Start - MSA | Experimental | Biological: UB-312 Injection, Biological: Placebo InjectionIncludes 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 - PD | Experimental | Biological: UB-312 Injection, Biological: Placebo InjectionIncludes 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). |
| Delayed Start - PD | Experimental | Biological: UB-312 Injection, Biological: Placebo InjectionIncludes 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). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent is signed and dated by the participant.
- Male or female aged 40 to 75 years old, inclusive, at screening.
- Participants must have a body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
- Expected to be able to undergo all study procedures.
- Women must be of non-childbearing potential (postmenopausal for at least 12 months before screening or surgically sterile) or, if of childbearing potential, must be using medically acceptable contraceptive measures throughout the study and for at least 24 weeks after their last dose of study treatment.
Key exclusion criteria (21 listed)
- Clinically significant abnormalities, as judged by the investigator, in test results (including hepatic and renal panels, complete blood count, chemistry panel, a level of anti-cyclic citrullinated peptide (anti-CCP) above the upper limit of normal (ULN) at Screening, positive antinuclear antibodies (ANA), except judged to be clinically irrelevant by the investigator, urinalysis, ECG and imaging), or vital signs. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant.
- History of medical, neurological, or psychiatric conditions, which in the opinion of the investigator, may compromise the participant's safety or scientific value of the study, posing an unacceptable risk to the participant or interfering with the participant's ability to comply with the study procedures or abide by study restrictions.
- History of Substance Use Disorder within the past 2 years before screening (Diagnostic and Statistical Manual of Mental Disorders-5 [DSM-V] criteria).
- Acute or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) at Screening or any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 infection, or cytotoxic therapy in the previous 5 years.
- History or evidence of an autoimmune disorder (e.g. Sjogren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.), which in the opinion of the investigator may compromise the patient's safety or scientific value of the study, posing an unacceptable risk to the participant.
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 |
|---|---|---|
| UB-312 InjectionUB-312, provided by Vaxxinity, contains 300 μg of p4573kb Drug Substance (synthetic peptide immunogen) formulated with CpG1 and Adju-Phos as a white, opaque, liquid suspension. The biological will be injected intramuscularly. The injection site will be the deltoid muscle. | Biological | Delayed Start - MSA, Delayed Start - PD, Treatment First - MSA, Treatment First - PD |
| Placebo InjectionPlacebo will be injected intramuscularly. The injection site will be the deltoid muscle. | Biological | Delayed Start - MSA, Delayed Start - PD, Treatment First - MSA, Treatment First - PD |
Primary outcome
Change in Serum Levels of anti-aSyn Antibodies from First Injection
Time frame: Day 1, Week 133
Derived from participant serum samples and calculated using a validated enzyme immunoassay.
Change in CSF Levels of anti-aSyn Antibodies from First Injection
Time frame: Day 1, Week 133
Derived from participant cerebrospinal fluid (CSF) samples and calculated using a validated enzyme immunoassay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Horacio.kaufmann@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Horacio Kaufmann, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UB-312 Injection in people with Multiple System Atrophy and Parkinson Disease, run by NYU Langone Health at 1 site in United States.
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 10 inclusion and 21 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: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Serum Levels of anti-aSyn Antibodies from First Injection (time frame: Day 1, Week 133). The study lists 2 primary outcomes in all. 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 16 Mar 2026.