GSK: Protocol Summary for A4M105038

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Protocol Summary for A4M105038

Protocol Summary
Protocol Id:	A4M105038
Secondary Ids:
Title:	Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months Administration of SB-683699 in Subjects with Relapsing-Remitting Multiple Sclerosis
Phase:	phase 2
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	United Kingdom: Medicines and Healthcare products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices
Collaborators:
Brief Summary:	SB-683699 is an oral medication that is thought to reduce the number of active white blood cells entering the brain; these white blood cells are part of the disease process for MS. This study will look at whether different doses of SB-683699 are effective and safe in patients with relapsing remitting MS.
Detailed Description:
Record Verification Date:	February 2012
Status:	Completed
Why Study Stopped:
Study Start Date:	December 2006
Study Completion Date:	August 2010
Study Completion Date Type:	Actual
Primary Completion Date:	August 2009
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	yes
Masked Caregiver:	yes
Masked Investigator:	yes
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Cumulative number of new gadolinium-enhancing lesions on monthly MRI scans during the Treatment Phase Baseline and 24 weeks
Secondary Outcomes:	Cumulative number of new T1 hypointense lesions on MRI scans Baseline and 24 weeks Cumulative number of persistent gadolinium-enhancing lesions on monthly 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 Change from Baseline in Expanded Disability Status Scale (EDSS) scores Baseline and 24 weeks Cumulative number of new/newly enlarging T2 lesions on MRI scans Baseline and 24 weeks Cumulative volume of new gadolinium-enhancing lesions on monthly MRI scans Baseline and 24 weeks Change from Baseline in Multiple Sclerosis Functional Composite (MSFC)scores Baseline and 24 weeks Relapses Occurring during the On-Treatment Phase Baseline and 24 weeks
Conditions:	Multiple Sclerosis
Keywords:	multiple sclerosis magnetic resonance imaging SB-683699
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion criteria: •Written informed consent •Males or females, aged 18 to 65, inclusive •A diagnosis of relapsing-remitting MS [Polman, 2005; McDonald, 2001] with dissemination in time and space •EDSS of between 0 and 6.0 inclusive at the Screening visit •Occurrence of at least two relapses in previous 24 months with at least one relapse or documented evidence of gadolinium-enhancement on MRI (prior to screening) in the previous 12 months. Subject must not have had a relapse within 4 weeks prior to Screening. In addition, subjects experiencing a relapse between Screen and Visit 3 will not be eligible to be randomized. •A minimum of five T2 lesions on brain MRI at Visit 2 as determined by the central MRI analysis reader •A female subject is eligible to enter the study if she is: •Of non-childbearing potential, i.e. women who: •have documented evidence of tubal ligation, bilateral oophorectomy or hysterectomy; or •are post-menopausal, defined as at least one year without menses in the absence of hormone replacement therapy. In questionable cases, menopausal status will be confirmed by oestradiol and FSH levels consistent with menopause according to local laboratory ranges. Oestrogen-containing hormone replacement therapies are not allowed during the study. •Of childbearing potential, has a negative urine pregnancy test at Screening, and agrees to the consistent and correct use of one of the methods of contraception listed below. Subjects will use this contraceptive method for at least one month prior to Screening and should continue to use the same contraceptive method throughout the study until at least 3 days after the last dose of investigational product. •Progesterone-only oral contraceptives or implants (inserted at least one month prior to Screening, but not beyond the third successive year following insertion). Oestrogen-containing contraceptives are not allowed during the study. •Intra-uterine device (IUD) inserted by a qualified clinician. The IUD must have published data showing that the highest expected failure rate is less than 1% per year. •Spermicide in conjunction with either a diaphragm, cervical cap or condom. Male partner sterilization (vasectomy) prior to female subject's entry into the study and is the sole partner for that female subject •In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. 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
Gender:	Both
Minimum Age:	18 Year
Maximum Age:	65 Year
Enrollment:	343
Enrollment Type:	Actual
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Australia (click to view all sites in Australia) GSK Investigational Site Camperdown, New South Wales, 2050; Completed; GSK Investigational Site Woodville, South Australia, 5011; Completed; GSK Investigational Site Parkville, Victoria, 3050; Completed; GSK Investigational Site Fitzroy, Victoria, 3065; Completed; Austria (click to view all sites in Austria) GSK Investigational Site Graz, A-8036; Completed; GSK Investigational Site Innsbruck, A-6020; Terminated; Canada (click to view all sites in Canada) GSK Investigational Site Ottawa, Ontario, K1H 8L6; Completed; GSK Investigational Site London, Ontario, N6A 5C1; Completed; GSK Investigational Site Gatineau, Québec, J9J 0A5; Completed; GSK Investigational Site Greenfield Park, Québec, J4V 2J2; Completed; Finland (click to view all sites in Finland) GSK Investigational Site Turku, 20100; Terminated; France (click to view all sites in France) GSK Investigational Site Lille, 59000; Completed; GSK Investigational Site Rennes Cedex 9, 35033; Completed; GSK Investigational Site Clermont Ferrand, 63003; Completed; GSK Investigational Site Strasbourg, 67091; Completed; GSK Investigational Site Marseille, 13385; Completed; GSK Investigational Site Dijon, 21033; Completed; GSK Investigational Site Nantes, 44093; Completed; Germany (click to view all sites in Germany) GSK Investigational Site Neuburg / Donau, Bayern, 86633; Completed; GSK Investigational Site Berlin, Berlin, 12167; Completed; GSK Investigational Site Berlin, Berlin, 10625; Completed; GSK Investigational Site Berlin, Berlin, 10961; Completed; GSK Investigational Site Hamburg, Hamburg, 22087; Completed; GSK Investigational Site Herborn, Hessen, 35745; Completed; GSK Investigational Site Rostock, Mecklenburg-Vorpommern, 18147; Completed; GSK Investigational Site Achim, Niedersachsen, 28832; Completed; GSK Investigational Site Hannover, Niedersachsen, 30625; Completed; GSK Investigational Site Essen, Nordrhein-Westfalen, 45122; Completed; GSK Investigational Site Koeln, Nordrhein-Westfalen, 51109; Completed; GSK Investigational Site Koeln, Nordrhein-Westfalen, 50767; Completed; GSK Investigational Site Dueren, Nordrhein-Westfalen, 52349; Completed; GSK Investigational Site Bad Honnef, Nordrhein-Westfalen, 53604; Completed; GSK Investigational Site Bielefeld, Nordrhein-Westfalen, 33647; Completed; GSK Investigational Site Leipzig, Sachsen, 04103; Completed; GSK Investigational Site Leipzig, Sachsen, 04157; Completed; GSK Investigational Site Dresden, Sachsen, 01307; Completed; Italy (click to view all sites in Italy) GSK Investigational Site Chieti, Abruzzo, 66013; Completed; GSK Investigational Site Roma, Lazio, 00163; Completed; GSK Investigational Site Gallarate, Lombardia, 21013; Completed; GSK Investigational Site Milano, Lombardia, 20132; Completed; GSK Investigational Site Siena, Toscana, 53100; Completed; Netherlands (click to view all sites in Netherlands) GSK Investigational Site EINDHOVEN, 5623 EJ; Completed; GSK Investigational Site VENRAY, 5801 CE; Completed; GSK Investigational Site BREDA, 4818 CK; Completed; GSK Investigational Site SITTARD-GELEEN, 6162 BG; Completed; GSK Investigational Site DEN BOSCH, 5211 RW; Completed; GSK Investigational Site NIEUWEGEIN, 3435 CM; Completed; New Zealand (click to view all sites in New Zealand) GSK Investigational Site Auckland, 1001; Completed; GSK Investigational Site Wellington, 6021; Completed; GSK Investigational Site Christchurch, 8001; Completed; Norway (click to view all sites in Norway) GSK Investigational Site Hamar, 2317; Completed; GSK Investigational Site Bergen, 5021; Completed; GSK Investigational Site Drammen, 3004; Completed; GSK Investigational Site Sandnes, 4313; Completed; GSK Investigational Site Skien, 3710; Completed; Poland (click to view all sites in Poland) GSK Investigational Site Gdansk, 80-299; Completed; GSK Investigational Site Poznan, 61-298; Completed; GSK Investigational Site Poznan, 60-479; Completed; GSK Investigational Site Warsaw, 02-097; Completed; Russian Federation (click to view all sites in Russian Federation) GSK Investigational Site St. Petersburg, 197022; Completed; GSK Investigational Site Moscow, 117049; Completed; GSK Investigational Site St-Petersburg, 194354; Completed; GSK Investigational Site St.-Petersburg, 194291; Completed; GSK Investigational Site Moscow, 125367; Completed; GSK Investigational Site Moscow, 125101; Completed; GSK Investigational Site St.-Petersburg, 197376; Completed; Spain (click to view all sites in Spain) GSK Investigational Site Sevilla, 41071; Completed; GSK Investigational Site Madrid, 28035; Completed; GSK Investigational Site San Sebastián, 20014; Completed; GSK Investigational Site Madrid, 28046; Completed; GSK Investigational Site Barcelona, 08035; Completed; GSK Investigational Site Madrid, 28007; Completed; GSK Investigational Site Barakaldo (Vizcaya), 48903; Completed; GSK Investigational Site Valencia, 46010; Completed; United Kingdom (click to view all sites in United Kingdom) GSK Investigational Site Newcastle-Upon-Tyne, NE1 4LP; Completed; GSK Investigational Site Sheffield, S10 2JF; Completed; GSK Investigational Site Nottingham, NG7 2UH; Completed; GSK Investigational Site Hartshill, Stoke-on-Trent, ST4 7LN; Completed; GSK Investigational Site Romford, Essex, RM7 0AG; Completed;

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Protocol Summary for A4M105038