Back to resultsExtension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
Primary Purpose
Progressive Supranuclear Palsy (PSP)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABBV-8E12
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Supranuclear Palsy (PSP)
Eligibility Criteria
Inclusion Criteria:
- Subject completed Study C2N-8E12-WW-104 (NCT02494024)
- Subject was not eligible to enroll in Study M15-562 (NCT02985879)
Exclusion Criteria:
- 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
Sites / Locations
- University of California, San /ID# 170113
- Texas Health Physicians Group /ID# 170112
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABBV-8E12
Arm Description
ABBV-8E12 administered by intravenous (IV) infusion.
Outcomes
Primary Outcome Measures
Adverse Events
Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03413319
Brief Title
Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
Official Title
Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy (PSP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABBV-8E12
Arm Type
Experimental
Arm Description
ABBV-8E12 administered by intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
ABBV-8E12
Other Intervention Name(s)
Tilavonemab
Intervention Description
Solution for infusion
Primary Outcome Measure Information:
Title
Adverse Events
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject completed Study C2N-8E12-WW-104 (NCT02494024)
Subject was not eligible to enroll in Study M15-562 (NCT02985879)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San /ID# 170113
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Texas Health Physicians Group /ID# 170112
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
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