Extension Study of ABBV-8E12 in Patients With Progressive... | NCT03413319

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

NCT03413319

Sponsor

AbbVie

Status

Completed

Last Update Posted

Dec 3, 2019Actual

Enrollment

3Actual

Phase

Phase 1

Conditions

Progressive Supranuclear Palsy (PSP)

Interventions

ABBV-8E12

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2018Actual

Primary Completion Date

Nov 20, 2019Actual

Completion Date

Nov 20, 2019Actual

First Submitted Date

Jan 23, 2018

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2019

Last Update Posted Date

Dec 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABBV-8E12	Experimental	ABBV-8E12 administered by intravenous (IV) infusion.	Drug: ABBV-8E12

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABBV-8E12	Drug	Solution for infusion	ABBV-8E12	Tilavonemab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AbbVie Inc.	AbbVie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San /ID# 170113		La Jolla	California	92093	United States
Texas Health Physicians Group /ID# 170112

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013494	Supranuclear Palsy, Progressive

Ancestor Terms

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000628586	tilavonemab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided