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Multiple SclerosisPhase 2NCT00395317

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

A Phase 2 study testing Firategrast 150 mg and Firategrast 300 mg in people with Multiple Sclerosis, run by GlaxoSmithKline at 79 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Firategrast 150 mg and Firategrast 300 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
343 participants
Where
79 sitesin 14 countries
Study dates
Dec 2006to Aug 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

79 sites in 14 countries.

79 sites in 14 countries

Germany18 sites

  • GSK Investigational Site

    Achim, Lower Saxony, 28832

  • GSK Investigational Site

    Bad Honnef, North Rhine-Westphalia, 53604

  • GSK Investigational Site

    Berlin, State of Berlin, 10625

  • GSK Investigational Site

    Berlin, State of Berlin, 10961

  • GSK Investigational Site

    Berlin, State of Berlin, 12167

  • GSK Investigational Site

    Bielefeld, North Rhine-Westphalia, 33647

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50767

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51109

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Düren, North Rhine-Westphalia, 52349

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22087

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Herborn, Hesse, 35745

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04157

  • GSK Investigational Site

    Neuburg an der Donau, Bavaria, 86633

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18147

Other trials in Germany

Spain8 sites

  • GSK Investigational Site

    Barakaldo (Vizcaya), 48903

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28035

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    Seville, 41071

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

France7 sites

  • GSK Investigational Site

    Clermont-Ferrand, 63003

  • GSK Investigational Site

    Dijon, 21033

  • GSK Investigational Site

    Lille, 59000

  • GSK Investigational Site

    Marseille, 13385

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Rennes, 35033

  • GSK Investigational Site

    Strasbourg, 67091

Other trials in France

Russia7 sites

  • GSK Investigational Site

    Moscow, 117049

  • GSK Investigational Site

    Moscow, 125101

  • GSK Investigational Site

    Moscow, 125367

  • GSK Investigational Site

    Saint Petersburg, 194291

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 197376

Other trials in Russia

Netherlands6 sites

  • GSK Investigational Site

    's-Hertogenbosch, 5211 RW

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Nieuwegein, 3435 CM

  • GSK Investigational Site

    Sittard-geleen, 6162 BG

  • GSK Investigational Site

    Venray, 5801 CE

Other trials in Netherlands

Italy5 sites

  • GSK Investigational Site

    Chieti, Abruzzo, 66013

  • GSK Investigational Site

    Gallarate, Lombardy, 21013

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Rome, Lazio, 00163

  • GSK Investigational Site

    Siena, Tuscany, 53100

Other trials in Italy

Norway5 sites

  • GSK Investigational Site

    Bergen, 5021

  • GSK Investigational Site

    Drammen, 3004

  • GSK Investigational Site

    Hamar, 2317

  • GSK Investigational Site

    Sandnes, 4313

  • GSK Investigational Site

    Skien, 3710

Other trials in Norway

United Kingdom5 sites

  • GSK Investigational Site

    Hartshill, Stoke-on-Trent, ST4 7LN

  • GSK Investigational Site

    Newcastle upon Tyne, NE1 4LP

  • GSK Investigational Site

    Nottingham, NG7 2UH

  • GSK Investigational Site

    Romford, Essex, RM7 0AG

  • GSK Investigational Site

    Sheffield, S10 2JF

Other trials in United Kingdom

Australia4 sites

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Parkville, Victoria, 3050

  • GSK Investigational Site

    Woodville, South Australia, 5011

Other trials in Australia

Canada4 sites

  • GSK Investigational Site

    Gatineau, Quebec, J9J 0A5

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2J2

  • GSK Investigational Site

    London, Ontario, N6A 5C1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Poland4 sites

  • GSK Investigational Site

    Gdansk, 80-299

  • GSK Investigational Site

    Poznan, 60-479

  • GSK Investigational Site

    Poznan, 61-298

  • GSK Investigational Site

    Warsaw, 02-097

Other trials in Poland

New Zealand3 sites

  • GSK Investigational Site

    Auckland, 1001

  • GSK Investigational Site

    Christchurch, 8001

  • GSK Investigational Site

    Wellington, 6021

Other trials in New Zealand

Austria2 sites

  • GSK Investigational Site

    Graz, A-8036

  • GSK Investigational Site

    Innsbruck, A-6020

Other trials in Austria

Finland1 site

  • GSK Investigational Site

    Turku, 20100

Other trials in Finland

About this study

Official 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

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.

Being tested
Placebo, Firategrast 150 mg, Firategrast 300 mg
Keywords
magnetic resonance imaging, multiple sclerosis, SB-683699
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    placebo tablet

  • Firategrast 150 mgDrug

    Also called SB-683699

    150 mg tablet

  • Firategrast 300 mgDrug

    Also called SB-683699

    300 mg tablet

Study groups in NCT00395317
Study groupRoleWhat they receive
Arm 1Placebo comparatorplacebo (4 tablets)
Receives: Other: Placebo
Arm 2ExperimentalSB-683699 150 mg bid (1 x 150mg + 3 placebo tablets)
Receives: Other: Placebo; Drug: Firategrast 150 mg
Arm 3ExperimentalSB-683699 600 mg bid (2 x 300mg + 2 placebo tablets)
Receives: Other: Placebo; Drug: Firategrast 300 mg
Arm 4ExperimentalSB-683699 900 mg bid (3 x 300 mg + 1 placebo tablet)
Receives: Other: Placebo; Drug: Firategrast 300 mg
Arm 5ExperimentalSB-683699 1200 mg bid, male subjects only (4 x 300 mg tablets)
Receives: Drug: Firategrast 300 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative number of new gadolinium-enhancing lesions on monthly MRI scans during the Treatment Phase

    Measured: Baseline and 24 weeks

Secondary outcomes (8)

  1. Cumulative volume of new gadolinium-enhancing lesions on monthly MRI scans

    Measured: Baseline and 24 weeks

  2. Cumulative number of persistent gadolinium-enhancing lesions on monthly MRI scans

    Measured: Baseline and 24 weeks

  3. Cumulative number of total enhancing lesions on monthly MRI scans: the sum of new and persistent gadolinium-enhancing lesions

    Measured: Baseline and 24 weeks

  4. Cumulative number of new T1 hypointense lesions on MRI scans

    Measured: Baseline and 24 weeks

  5. Cumulative number of new/newly enlarging T2 lesions on MRI scans

    Measured: Baseline and 24 weeks

  6. Relapses Occurring during the On-Treatment Phase

    Measured: Baseline and 24 weeks

  7. Change from Baseline in Expanded Disability Status Scale (EDSS) scores

    Measured: Baseline and 24 weeks

  8. Change from Baseline in Multiple Sclerosis Functional Composite (MSFC)scores

    Measured: Baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionAug 2009
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00395317
Sponsor's protocol ID
A4M105038
Status last verified
Apr 2012
First submitted
1 Nov 2006
Last updated
9 Apr 2012
Results posted
No
Data monitoring committee
No

Publications

  • Miller DH, Weber T, Grove R, Wardell C, Horrigan J, Graff O, Atkinson G, Dua P, Yousry T, Macmanus D, Montalban X. Firategrast for relapsing remitting multiple sclerosis: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2012 Feb;11(2):131-9. doi: 10.1016/S1474-4422(11)70299-X. Epub 2012 Jan 5.

    PubMed 22226929

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Firategrast 150 mg and Firategrast 300 mg in people with Multiple Sclerosis, run by GlaxoSmithKline at 79 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in Germany, Spain, France, Russia, Netherlands and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative number of new gadolinium-enhancing lesions on monthly MRI scans during the Treatment Phase (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00395317, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2012.

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