Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

October 01, 2014

Institutional Review Board, Hospital for Special Surgery

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Principal Investigator

Doruk Erkan, MD, MPH

Summary

• 3 patients
• Screen (4 weeks)
• Treatment (24 weeks)
• Follow-up (24 weeks)
• 13 clinic visits during the 48 month study + Screening visit

Inclusion/Exclusion Criteria

Inclusion Criteria (selected):
1. Male or female of ≥18 years of age
2. Diagnosis of SLE satisfying at least 4 out of the 11 ACR classification criteria
3. Disease duration of at least 6 months from the time of diagnosis
4. SLEDAI-2K score ≥6 at screening visit.
History of vaccinations against S. pneumococcus and influenza virus (as seasonally required),or vaccination against these pathogens at the screening visit. Subjects receiving one or more of these vaccinations at the screening visit must have at least 2 weeks between the vaccination and the date of randomization. (Live or live-attenuated vaccines are not permitted

Exclusion Criteria (selected) :
1. Pregnancy
2. Within 2 weeks prior to screening visit: Use of corticosteroids (CS) exceeding 40 mg daily prednisone or equivalent.  Increase in dosing of CS, or Use of injectable CS
3. Introduction of mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) within2 months prior to screening , increase in dosing within 1 month before screening , or use of intravenous mycophenolic acid(MPA or mycophenolate) in the 2 months prior to screening
4. Use of cyclophosphamide within 3 months before screening
5. Use of belimumab (or other anti-BLyS therapy) rituximab, ocrelizumab, or other B cell-directed biologic therapies within 1 year before screening

 

Contact Information

Glendalee Ramón
ramong@hss.edu
212-774-2808