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CompletedNCT03413319Updated Dec 3, 2019

Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104

A Phase 1 interventional study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP), sponsored by AbbVie. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by AbbVie · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2019, 6 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Progressive Supranuclear Palsy (PSP)
03

In context

Supranuclear Palsy, Progressive

171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.

This study's enrollment of 3 is below the median of 43 across 102 interventional studies indexed under Supranuclear Palsy, Progressive.

Browse Supranuclear Palsy, Progressive studies →

Lead sponsor

AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Browse AbbVie studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject completed Study C2N-8E12-WW-104 (NCT02494024)
  • Subject was not eligible to enroll in Study M15-562 (NCT02985879)

Exclusion criteria

Exclusion Criteria:

  • Subject weighs less than 35 kg at screening
  • Subject has any 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    ABBV-8E12

    ABBV-8E12 administered by intravenous (IV) infusion.

    Drug: ABBV-8E12

Interventions

  • DrugABBV-8E12

    Solution for infusion

    Also known as: Tilavonemab

06

What researchers measure

Primary outcomes

  1. Adverse Events

    Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.

    Time frame: From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)

07

Study locations

2 sites
  • University of California, San /ID# 170113
    La Jolla, California 92093, United States
  • Texas Health Physicians Group /ID# 170112
    Dallas, Texas 75218, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Nov 2019, 19 months.

Of 15 phase 1 interventional studies under Supranuclear Palsy, Progressive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 23. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Jan 29, 2018
StartActual
Apr 17, 2018
Primary completionActual
Nov 20, 2019
CompletionActual
Nov 20, 2019
Last update
Dec 3, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03413319
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Apr 17, 2018
Primary completion
Nov 20, 2019
Completion
Nov 20, 2019
Last update
Dec 3, 2019

Study contacts

AbbVie Inc.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tilavonemab

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