[11C]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT 555 in Subjects With Relapsing Forms of Multiple Sclerosis

Phase 1

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: ABT-555

• Registration Number: NCT02606630
• Lead Sponsor: AbbVie

Brief Summary

This open-label positron emission tomography (PET) study is designed to determine the effect of ABT-555 on translocator protein expression level in participants with relapsing forms of multiple sclerosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Diagnosis of relapsing-remitting MS (RRMS) or relapsing secondary progressive MS (SPMS)

Neurologically stable at Screening, in the investigator's judgment and not actively experiencing or recovering from a recent relapse in the 30 days preceding the Screening Visit

A Kurtzke Expanded Disability Status Scale (EDSS) score of 1.0 to 6.0, inclusive at the Screening Visit

High or mixed affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at screening

Exclusion Criteria

Diagnosis of primary progressive or non-relapsing secondary progressive MS

Smoking more than 10 cigarettes per day or use of a nicotine patch

Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus

Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening

Any type of live virus vaccine from 4 weeks before randomization

History of abnormal laboratory results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABT-555	ABT-555	ABT-555 will be administered at Visit 4 for Part 2 only

Primary Outcome Measures

Name	Time	Method
Change in translocator protein expression	Day 0 and 109 days	Compare 2 dynamic positron emission tomography scans to examine the effect of a single administration of ABT-555 on translocator protein expression

Trial Locations

Locations (2)

Site Reference ID/Investigator# 141461; 🇬🇧 Whitechapel, United Kingdom

Site Reference ID/Investigator# 141463; 🇬🇧 London, United Kingdom