Progressive Supranuclear Palsy (PSP)Phase 1NCT03413319
Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
A Phase 1 study testing ABBV-8E12 in people with Progressive Supranuclear Palsy (PSP), run by AbbVie at 2 sites in United States.
Trial summary
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Supranuclear Palsy (PSP)
- What is being tested?
- ABBV-8E12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2018to 20 Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject completed Study C2N-8E12-WW-104 (NCT02494024)
- Subject was not eligible to enroll in Study M15-562 (NCT02985879)
Who cannot join
- Subject weighs less than 35 kg at screening
- Subject has any contraindication or inability to tolerate brain MRI
- Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Health Physicians Group /ID# 170112
Dallas, Texas, 75218
University of California, San /ID# 170113
La Jolla, California, 92093
About this study
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).
- Conditions
- Progressive Supranuclear Palsy (PSP)
- Being tested
- ABBV-8E12
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-8E12Drug
Also called Tilavonemab
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| ABBV-8E12 | Experimental | ABBV-8E12 administered by intravenous (IV) infusion. Receives: Drug: ABBV-8E12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.
Measured: From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start17 Apr 2018
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear Palsy (PSP)Studies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413319
- Sponsor's protocol ID
- M16-948
- Status last verified
- Dec 2019
- First submitted
- 23 Jan 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
- ClinicalTrials.gov ID
- NCT03413319
- Acronym / sponsor ID
- M16-948
- Conditions
- Progressive Supranuclear Palsy (PSP)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 29 Jan 2018 (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.
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABBV-8E12 | Experimental | Drug: ABBV-8E12ABBV-8E12 administered by intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject completed Study C2N-8E12-WW-104 (NCT02494024)
- Subject was not eligible to enroll in Study M15-562 (NCT02985879)
Key exclusion criteria (3 listed)
- Subject weighs less than 35 kg at screening
- Subject has any contraindication or inability to tolerate brain MRI
- Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
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 |
|---|---|---|
| ABBV-8E12Also: TilavonemabSolution for infusion | Drug | ABBV-8E12 |
Primary outcome
Adverse Events
Time frame: From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)
Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.
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 3 Dec 2019.
- Individual participant dataSharing planned: No
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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.
AbbVie Inc. study director
AbbVie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-8E12 in people with Progressive Supranuclear Palsy (PSP), run by AbbVie at 2 sites 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 2 inclusion and 3 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Adverse Events (time frame: From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)). 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 3 Dec 2019.