A randomised, double-blind, placebo-controlled,multicentre prospective dose-finding Phase II/III studywith atacicept given subcutaneously to subjects havingrecently experienced a flare of systemic lupuserythematosus (SLE)
- Conditions
- SLE10003816systemic lupus10010761
- Registration Number
- NL-OMON39295
- Lead Sponsor
- Merck BV - An affiliate of Merck Serono S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
Complete lists of inclusion and exclusion criteria may be found in Section 5.2.;The trial will enrol subjects from 16 years old of either gender who have a diagnosis of SLE satisfying at least 4 of the 11 ACR criteria and a disease history of at least six months. Eligible subjects must have active SLE with at least one BILAG A or B score at screening (excluding a single B due to haematological values) requiring a change in the dose of corticosteroids, and must have a positive antinuclear antibody (ANA) test (HEp-2 ANA 1:80 and/or anti-dsDNA 30 IU/mL) at the initial screening visit.
Complete lists of inclusion and exclusion criteria may be found in Section 5.2.;Subjects who have active moderate to severe glomerulonephritis will be excluded, as will those who have received any treatment with rituximab, abatacept or belimumab, those who have initiated new immunosuppressive drugs or have used cyclophosphamide, calcineurin inhibitors or investigational treatments within specified periods before screening, those who have had introduction of or increases in treatment regimen of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine or methotrexate within 2 months before the
screening visit, and those who have clinically significant abnormalities on screening
laboratory tests, or who have any condition that in the Investigator*s opinion constitutes a risk or a contraindication for participation to the trial or that could interfere with the trial objectives, conduct or evaluation.
Pregnant women and breastfeeding women will also be excluded.
History of any demyelinating disease, such as MS or ON.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary:<br /><br>The primary efficacy endpoint will be the proportion of subjects experiencing a<br /><br>new flare (as<br /><br>defined by a British Isles Lupus Assessment Group [BILAG] score of A or B)<br /><br>during the 52-<br /><br>week treatment period following randomisation.</p><br>
- Secondary Outcome Measures
Name Time Method