Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 343

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects receiving corticosteroids within 4 weeks of Screening for treatment of MS. If non-systemic steroids are being used for other chronic inflammatory conditions, subjects may be included at the discretion of the investigator after discussion with the GSK medical monitor
Use of an b-interferon product, glatiramer acetate or azathioprine within 3 months of Screening, or use of Mitoxantrone within 12 months of Screening. Subjects who have received other therapies affecting the immune system (such as intravenous immunoglobulin (IVIg), cyclophosphamide, plasmapheresis, or any other immunosuppressive or immunomodulatory treatment) in the past may be included on a case by case basis after discussion with the GSK medical monitor. None of these treatments will be allowed during this study
Previous exposure to alemtuzumab, natalizumab or firategrast administration, bone marrow transplantation or whole body irradiation
Subjects with a cardiac pacemaker or any other type of metal implant or with any other contraindication for MRI (including known allergy to gadolinium)
Use of 4-aminopyridine, rosiglitazone, pioglitazone or any drug that is an inhibitor of or a substrate (with a low therapeutic index) for OATP at Screening.
Subjects with clinically significant renal laboratory values: subjects with a calculated creatinine clearance <60ml/min (by Cockcroft and Gault) at Screening
Subjects with local urinalysis findings of 1) proteinuria, defined as ≥1+ protein, on urine dipstick or 2) renal tubular cell casts or 3) ≥5 red blood cells / high power field will be excluded from the study if the result is still present on a repeat urinalysis during the screening period.
Presence of clinically significant hepatic laboratory values: ALT, AST, GGT > 2.0- times the upper limit of normal (ULN); total bilirubin > 1.5 times the ULN at Screening
CD4 count <500, CD4:CD8 <1.0 (if result still present on a repeat test during the screening period), JC viremia detected in plasma or white cells, idiopathic CD4/CD8 lymphopenia or secondary lymphopenia at Screening
Any findings on the MRI of the brain at Visit 2 other than MS, except for benign findings that (in the opinion of the central MRI reading site and local site investigator) require no further evaluation or treatment and do not impact patient's neurological health (e.g., small arachnoid cysts, venous angiomas)
Current or history of cancer, excluding localized non-melanoma skin cancer
Uncontrolled or any active bacterial, viral, or fungal infection at Screening. Any previous serious infections should be discussed with the GSK medical monitor (e.g. opportunistic or atypical infections)
History of tuberculosis (TB) or positive chest X-ray for TB at Screening (prior chest X-ray is acceptable if performed within previous 6 months)
Known congenital or acquired immunodeficiency
Any abnormality on 12-lead ECG at Screening which is clinically significant in the opinion of the investigator
Subjects with positive hepatitis B surface antigen, hepatitis C antibody, or HIV tests at Screening
Women who are lactating, pregnant (positive pregnancy test at Screening), or planning to become pregnant during the course of the study
Recent history or suspicion of current drug abuse (including analgesic abuse) or alcohol abuse within the last 6 months prior to Screening
Use of an investigational drug for condition other than MS within 30 days or five half-lives (whichever is longer) preceding Screening. Prior use of an investigational drug for MS should be discussed with the GSK medical monitor
Any concurrent illness, disability or clinically significant abnormality (including laboratory tests) that may affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Placebo	placebo (4 tablets)
Arm 2	Placebo	SB-683699 150 mg bid (1 x 150mg + 3 placebo tablets)
Arm 2	Firategrast 150 mg	SB-683699 150 mg bid (1 x 150mg + 3 placebo tablets)
Arm 3	Placebo	SB-683699 600 mg bid (2 x 300mg + 2 placebo tablets)
Arm 3	Firategrast 300 mg	SB-683699 600 mg bid (2 x 300mg + 2 placebo tablets)
Arm 4	Placebo	SB-683699 900 mg bid (3 x 300 mg + 1 placebo tablet)
Arm 4	Firategrast 300 mg	SB-683699 900 mg bid (3 x 300 mg + 1 placebo tablet)
Arm 5	Firategrast 300 mg	SB-683699 1200 mg bid, male subjects only (4 x 300 mg tablets)

Primary Outcome Measures

Name	Time	Method
Cumulative number of new gadolinium-enhancing lesions on monthly MRI scans during the Treatment Phase	Baseline and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Cumulative number of new T1 hypointense lesions on MRI scans	Baseline and 24 weeks
Cumulative number of total enhancing lesions on monthly MRI scans: the sum of new and persistent gadolinium-enhancing lesions	Baseline and 24 weeks
Cumulative volume of new gadolinium-enhancing lesions on monthly MRI scans	Baseline and 24 weeks
Cumulative number of persistent gadolinium-enhancing lesions on monthly MRI scans	Baseline and 24 weeks
Cumulative number of new/newly enlarging T2 lesions on MRI scans	Baseline and 24 weeks
Relapses Occurring during the On-Treatment Phase	Baseline and 24 weeks
Change from Baseline in Expanded Disability Status Scale (EDSS) scores	Baseline and 24 weeks
Change from Baseline in Multiple Sclerosis Functional Composite (MSFC)scores	Baseline and 24 weeks

Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS)

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts