The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis

Status:	Terminated
Conditions:	Lupus, Nephrology
Therapuetic Areas:	Immunology / Infectious Diseases, Nephrology / Urology
Healthy:	No
Age Range:	16 - Any
Updated:	4/21/2016
Start Date:	December 2007
End Date:	April 2009

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects With Lupus Nephritis in Combination With Mycophenolate Mofetil Therapy.

The purpose of this study is to learn whether atacicept treatment leads to improvement in
kidney function in subjects with active lupus nephritis in combination with mycophenolate
mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International;
operational oversight was provided by ZymoGenetics.

Inclusion Criteria:

- Diagnosis of systemic lupus erythematosus (SLE) satisfying at least 4 out of the 11
American College of Rheumatology (ACR) criteria (Appendix B)

- Renal biopsy performed consistent with active International Society of
Nephrology/Renal Pathology Society (ISN/PRS) class III or IV lupus nephritis

Exclusion Criteria:

- Estimated glomerular filtration rate (GFR) less than or equal to (<=) 30 milliliter
per minute (mL/min) per 1.73 square meter (m^2)

- Active central nervous system SLE deemed to be severe or progressive and/or
associated with significant cognitive impairment

- Any treatment with MMF, azathioprine, or cyclophosphamide within the last 6 months,
or known hypersensitivity to MMF or atacicept.

- Any prior treatment with abatacept, rituximab, belimumab, or other B cell modulating
agents.

We found this trial at

sites

Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center

Beachwood, Ohio 44122

from

Beachwood, OH