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

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02606630
Enrollment
4
Registered
2015-11-17
Start date
2015-10-31
Completion date
2015-12-31
Last updated
2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Relapsing multiple sclerosis

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.

Interventions

ABT-555 will be administered on Visit 4 in Part 2 only

Sponsors

AbbVie
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in translocator protein expressionDay 0 and 109 daysCompare 2 dynamic positron emission tomography scans to examine the effect of a single administration of ABT-555 on translocator protein expression

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026