A PET study to evaluate the effect of ABT-555 in subjects with MS
Research type
Research Study
Full title
A [11C]-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
IRAS ID
189090
Contact name
Gavin Giovannoni
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2015-001176-22
Duration of Study in the UK
0 years, 10 months, 29 days
Research summary
We are conducting a clinical research study with a new medication known as ABT-555 which is being developed to treat patients with relapsing forms of Multiple Sclerosis (RFMS). Multiple Sclerosis (MS) affects nerves in the brain and spinal cord, causing a wide range of symptoms including problems with muscle movement, balance and vision. MS affects approximately 2.5 million people worldwide and around 85% of people with MS are diagnosed with the RFMS; as they have flare-ups of symptoms, known as relapses which can last from a few days to a few months. RFMS contributes to more severe MS symptoms including disability so more effective new medicines are needed.\n\nThe study will be carried out in 2 parts. Part 1 of the study (4 patients) is for validation of the Positron Emission Tomography (PET) method to be used in Part 2 of the study; so patients will not receive any study drug. Part 2 of the study (up to 20 patients) will investigate the binding of ABT-555 to disease relevant binding sites in the brain. ABT-555 will be given to patients in Part 2 of the study by intravenous (IV) infusion (delivered through tubing by a needle into the vein). \n\nWe will also assess the safety and tolerability of ABT-555 in MS patients. The study procedures include safety assessments, blood samples taken for antibody tests, pharmacokinetic and genetic analysis, Magnetic Resonance Imaging (MRI)and PET scans. Patients included in Part 2 of the study will also be required to provide responses to a suicide severity rating questionnaire.\n\nThe study will be conducted at multiple research centres in the UK. The study is sponsored by AbbVie (a pharmaceutical company based in Germany) and the data from this study will help to design further trials for bringing ABT-555 to market.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0516
Date of REC Opinion
18 Sep 2015
REC opinion
Favourable Opinion