Status:
WITHDRAWN
Atacicept Demonstrating Dose RESponSe
Lead Sponsor:
EMD Serono
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells make proteins ...
Eligibility Criteria
Inclusion
- Male or female of ≥18 years of age
- Written informed consent
- Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria during the course of their illness
- Disease duration of at least 6 months
- SLEDAI-2K score ≥ 6 at screening
- Positive test results for antinuclear antibody (ANA) (HEp-2 ANA ≥1:80) and/or anti-double-stranded deoxyribonucleic acid (dsDNA) (≥30 IU/mL) at screening
- Negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential.
Exclusion
- Increase in dosing of corticosteroids within 2 weeks prior to screening
- Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening
- Change in dosing of immunosuppressants or corticosteroids during the screening period
- Serum IgG \< 6g/L
- Estimated Glomerular Filtration Rate (GFR) \<50 mL/min/1.73m²
- Urinary protein:creatinine ratio \>2 mg/mg
- History of demyelinating disease
- Breastfeeding or pregnancy
- Legal or limited legal capacity
- Additional exclusion criteria also apply
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01440231
Start Date
February 1 2012
End Date
February 1 2014
Last Update
August 21 2013
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