Alzheimer's DiseasePhase 2NCT03531710
An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
A Phase 2 study testing UB-311 in people with Alzheimer's Disease, run by United Neuroscience Ltd. at 4 sites in Taiwan.
Trial summary
To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- UB-311
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 4 sitesTaiwan
- Study dates
- 10 Aug 2018to 31 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who participated in V203-AD trial without major safety concerns;
- Stable doses of permitted medications for 3 months before screening;
- With a caregiver;
- Other inclusion criteria apply
Who cannot join
- Clinically significant neurological disease other than Alzheimer's disease
- Major psychiatric disorder
- Severe systemic disease
- Serious adverse reactions to any vaccine
- Other exclusion criteria apply
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)
Kaohsiung City
National Taiwan University Hospital (NTUH)
Taipei
Taipei Veterans General Hospital (TVGH)
Taipei
Linkou Chang Gung Memorial Hospital (LK-CGMH)
Taoyuan
About this study
Official title: An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311)
To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period.
- Conditions
- Alzheimer's Disease
- Being tested
- UB-311, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-311Biological
Intramuscular injection
PlaceboDrug
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 3 boosters | Experimental | Subjects will receive 3 doses of UB-311 and 2 doses of placebo. Receives: Biological: UB-311; Drug: Placebo |
| 3 priming doses followed by 2 boosters | Experimental | Subjects will receive 5 doses of UB-311. Receives: Biological: UB-311 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).
Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests.
Measured: Overall Study Duration/Early Termination, over an average study duration of 326 days
Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aβ antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aβ antibodies is assessed at every visit throughout the study period.
Measured: Overall Study Duration/Early Termination, over an average study duration of 326 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start10 Aug 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Why it stopped: United Neuroscience has decided to terminate V203-AD-EXT study based on a treatment assignment error
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Neuroscience Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531710
- Sponsor's protocol ID
- V203-AD-EXT
- Status last verified
- Jan 2021
- First submitted
- 6 Apr 2018
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311)
- ClinicalTrials.gov ID
- NCT03531710
- Acronym / sponsor ID
- V203-AD-EXT
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: United Neuroscience has decided to terminate V203-AD-EXT study based on a treatment assignment error
- Enrolment
- 34 participants (actual)
- Lead sponsor
- United Neuroscience Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Posted 17 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 boosters | Experimental | Biological: UB-311, Drug: PlaceboSubjects will receive 3 doses of UB-311 and 2 doses of placebo. |
| 3 priming doses followed by 2 boosters | Experimental | Biological: UB-311Subjects will receive 5 doses of UB-311. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who participated in V203-AD trial without major safety concerns;
- Stable doses of permitted medications for 3 months before screening;
- With a caregiver;
- Other inclusion criteria apply
Key exclusion criteria (5 listed)
- Clinically significant neurological disease other than Alzheimer's disease
- Major psychiatric disorder
- Severe systemic disease
- Serious adverse reactions to any vaccine
- Other exclusion criteria apply
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-311Intramuscular injection | Biological | 3 boosters, 3 priming doses followed by 2 boosters |
| PlaceboIntramuscular injection | Drug | 3 boosters |
Primary outcome
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).
Time frame: Overall Study Duration/Early Termination, over an average study duration of 326 days
Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests.
Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
Time frame: Overall Study Duration/Early Termination, over an average study duration of 326 days
For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aβ antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aβ antibodies is assessed at every visit throughout the study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease.Link provided by the sponsor.
- UB-311, a novel UBITh® amyloid β peptide vaccine for mild Alzheimer's disease.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UB-311 in people with Alzheimer's Disease, run by United Neuroscience Ltd. at 4 sites in Taiwan.
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 5 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: stopped early, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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 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?
Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]). (time frame: Overall Study Duration/Early Termination, over an average study duration of 326 days). 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 26 Jan 2021.