None listed
Conditions
Interventions
This is a Phase IIb, multicenter, double-blind, placebo-controlled (DBPC) parallel-arm trial in
which 279 subjects are planned to be randomized in a ratio of 1:1:1 to receive placebo, or
atacice
Sponsors
Merck KGaA,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Male or female of 18 years of age, who provide written informed consent at the screening visit. 2. Diagnosis of SLE satisfying at least 4 out of the 11 ACR classification criteria for SLE during the course of their illness at the screening visit. 3. Disease duration of at least 6 months from the time of diagnosis (when the subject met at least 4 of the ACR criteria) at the screening visit. 4. SLEDAI-2K score 6 at screening visit. 5. Positive test results for ANA (human epithelial cell [Hep]-2 ANA 1:80) and/or anti-dsDNA antibody (30 IU/mL) at screening visit. 6. Women of childbearing potential (WOCBP) must use highly effective methods of contraception to prevent pregnancy for 4 weeks before randomization and must agree to continue to practice adequate contraception for 60 days after the last dose of IMP. For the purposes of this trial, WOCBP is defined as: All female subjects after puberty unless they are postmenopausal (defined by continuous amenorrhea) for at least 2 years or are surgically sterile. Highly effective contraception is defined as use of 2 barrier methods (e.g., female diaphragm and male condoms), 1 barrier method with spermicide, an intrauterine device or hormonal contraceptives (e.g., implant or oral). Note that because mycophenolate affects the metabolism of hormonal contraceptives and may reduce their effectiveness, women receiving mycophenolate who are using hormonal contraceptives for birth control should employ an additional contraceptive method (e.g., barrier method). 7. Women of childbearing potential must have a negative serum pregnancy test at screening visit and a negative urine pregnancy test at Day 1/randomization before dosing. 8. 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 per Section 6.5.2).
Exclusion criteria
Exclusion criteria: Subjects are not eligible for this trial if they fulfill any of the following exclusion criteria. Patients will be excluded if any of these conditions apply to previous or pre-existing therapies: 1. Within 2 weeks prior to screening visit: a. Use of corticosteroids (CS) exceeding 40 mg daily prednisone or equivalent. b. Increase in dosing of CS. c. Use of injectable CS. 2. During the screening period, use of oral CS exceeding 40 mg daily prednisone-equivalent (increases in oral CS doses are permitted). 3. Introduction of mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) within 2 months prior to screening visit, increase in dosing within 1 month before screening visit or any change in dosing during the screening visit, or use of intravenous mycophenolic acid (MPA or mycophenolate) in the 2 months prior to the screening visit or during the screening visit. 4. Use of cyclophosphamide within 3 months before or during the screening visit. 5. Introduction of, increase in dosing, or use of a dose exceeding the maximum specified dose of any other medication considered to have immunosuppressant or immunomodulating properties within 1 month before the screening visit or introduction of or a change in dosing of any of these medications during the screening visit. 6. Use of more than 1 medication considered to have immunosuppressant or immunomodulatory properties as permitted by Section 6.5.1, not including antimalarials or CS, after the screening visit. 7. Initiation of antimalarial treatment after the screening visit. 8. Use of belimumab (or other anti-BLyS therapy) rituximab, ocrelizumab, or other B cell-directed biologic therapies within 1 year before the screening visit. 9. Use of abatacept or any TNF-inhibitor therapy within 2 months before the screening visit. 10. Immunization with live or live-attenuated vaccines within 1 month before or during the screening visit. 11. Use of Ig treatment within 2 months before the screening visit. 12. Initiation of or change in dosing of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker within 2 weeks before the screening visit. 13. Treatment with other investigational agents within the last 3 months or 5 half-lives, or as per washout requirement from the previous protocol, whichever is longest, prior to the screening visit. 14. Prior anaphylactic reaction to a biologic therapy. 15. Nonsteroidal anti-inflammatory drugs (NSAIDs) used above maximum prescribed dose per local label during the screening visit. 16. Subjects previously participating in any atacicept trial. 17. Presence of systemic rheumatic disease other than SLE (secondary Sjogren’s syndrome due to SLE is permitted). 18. Weight is <41 kg (90.2 pounds) and body mass index is <17.5 at the screening visit. 19. Use of herbal supplements after the screening visit. Medical Conditions: 20. Any condition, including any uncontrolled disease state other than SLE, that in the investigator’s opinion or sponsor/designee opinion constitutes an inappropriate risk or a contraindication for participation in the trial or that could interfere with the trial objectives, conduct or evaluation. 21. Cardiovascular events including acute myocardial infarction, unstable angina or peripheral vascular disease symptoms, hospitalization for congest
Countries
Arabia Saudi, Argentina, Australia, Austria, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Israel, Italy, Japan, Korea South, Lebano, Lithuania, Malasya, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed