A study to assess the efficacy and safety of GSK2586184 in SLE

• Conditions: Systemic Lupus Erythematosus; MedDRA version: 16.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2012-001645-41-PL
• Lead Sponsor: GlaxoSmithKline Research and Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-20
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Subjects eligible for enrolment in the study must meet all of the following criteria:
1. Age and Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent.
2. SLE classification: Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria, with 4 or more of the 11 ACR criteria present, serially or simultaneously during any interval or observation.
3. Severity of disease: Have clinically active SLE disease defined as a SELENA SLEDAI score =8 at screening during the 35-day screen period.
4. Auto antibodies: Are serologically active having unequivocally positive antinuclear antibody (ANA) or anti-double stranded DNA (anti-dsDNA) antibody test results from 2 independent time points as follows:
• Positive test results from 2 independent time points within the study screening period. Screening results must be based on the study’s central laboratory results. A positive test is defined as a positive ANA test equivalent to a titre =1:80 as defined in the central laboratory manual and/or a positive anti-dsDNA (=30 IU/mL) serum antibody.
OR
• One positive historical test result and 1 positive test result for either ANA or anti-dsDNA during the screening period.
Historical documentation of a positive test of ANA (e.g., ANA by HEp-2 titre) or anti-dsDNA antibody (e.g., anti-dsDNA by Farr assay) must include the date and type of the test, the name of the testing laboratory, numerical reference range, and a key that explains values provided as positive vs. negative OR negative,
equivocal/borderline positive). Only unequivocally positive values as defined in the laboratory’s reference range are acceptable; borderline values will not be accepted.
5. Treatment for SLE: patient stable on either no treatment or on a stable dose of corticosteroids (=15mg/day prednisone or prednisone equivalent or less) stable for a minimum of 30 days prior to screening and through to Day 0/Randomisation and /or an anti-malarial therapy[hydroxychloroquine (=400mg daily dose) or chloroquine (= 500mg daily dose) or quinacrine ( =100mg daily dose)]for a minimum of 60 days prior to the Day 0/Randomisation Visit. Subjects receiving azathioprine (= 2mg/kg/day or = 150mg/day, whichever is greater) or mycophenolate mofetil (= 1.5g/day), or MTX (=20mg/week), either alone or in addition to steroids and / or an anti-malarial therapy as described above, if they have been on a stable dose of azathioprine OR mycophenolate mofetil OR MTX for a minimum of 90 days prior to the Day 0 /Randomisation Visit.
For those subjects on alternating day dosing of steroids, use the average of 2 daily doses to calculate the average daily steroid dose.
6. ECG: Single QTc, < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
7. Prevention of Pregnancy:
Females: A female subject is eligible to participate if she is not pregnant, as confirmed by a negative serum human chorionic gonadotrophin (hCG) test, or lactating and at least one of the following conditions applies: Please refer to page 41 bullet point 7 of the study protocol for details.
8. Informed consent: Capable of giving written informed consent, including confirmation that the subject is not mentally or legally incapacitated, and compliance with the requirements and restrictions listed in the consent form.
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study:
1. Kidney Disease
2. CNS Disease
3. Alcohol Abuse
4. Substance Abuse
5. Hepatitis B
6. Hepatitis C
7. HIV
8. Previous investigational product exposure
9. Previous and current medication
10. Prior biological therapies
11. Transplantation
12. Uncontrolled Other Diseases
13. Surgery and Other Conditions
14. Cancer
15. Infections
16. Mycobacterium Tuberculosis
17. Haematology
18. Serum immunoglobulin (Ig) levels
19. Liver Function Tests
20. Other laboratory abnormalities
21. Drug sensitivity
22. Blood donation
* Please refer to the study protocol section 5.3 Exclusion Criteria pages 43-44 for further details.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified