NCT03413319

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

1.6 years

First QC Date

January 23, 2018

Last Update Submit

December 2, 2019

Conditions

Progressive Supranuclear Palsy (PSP)

Outcome Measures

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.

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

Study Arms (1)

ABBV-8E12

EXPERIMENTAL

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

Drug: ABBV-8E12

Interventions

ABBV-8E12DRUG

Solution for infusion

Also known as: Tilavonemab
ABBV-8E12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San /ID# 170113

La Jolla, California, 92093, United States

Location

Texas Health Physicians Group /ID# 170112

Dallas, Texas, 75218, United States

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

tilavonemab

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 29, 2018

Study Start

April 17, 2018

Primary Completion

November 20, 2019

Study Completion

November 20, 2019

Last Updated

December 3, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)