None listed
Conditions
Interventions
subjects will receive atacicept 75 or 150 mg, given as
once weekly (QW) subcutaneous (SC) injections.
Eligible subjects who complete the 24-week treatment
period of EMR-700461-023 (ADDRESS II
Recipients of placebo will be switched to receive
atacicept 150 mg QW in the LTE trial.

Recipients of 75 mg atacicept QW will continue to
receive this dose in the LTE trial.

Recipients of 150 mg atacicept QW will continue to
receive this dose in the LTE trial.
The trial is composed of a treatment period of
approximately 2 years (96 weeks) duration and a safety
Sponsors
Merck KGaA,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Subjects have completed the 24-week treatment period of trial EMR-700461-023 (ADDRESS II core trial). 2. Written informed consent must be given before any procedure relating to this extension trial. Subjects must have read and understood the informed consent form (ICF), must fully understand the requirements of the trial, and must be willing to comply with all trial visits and assessments. 3. Women of childbearing potential (WOCBP) must use highly effective methods of contraception to prevent pregnancy 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 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). 4. WOCBP must have a negative urine pregnancy test at the baseline trial visit (Day 1) before dosing.
Exclusion criteria
Exclusion criteria: 1. Have withdrawn during the core trial due to any of the pre-defined criteria for withdrawal 2. Any condition, including any uncontrolled disease state other than SLE, findings in the laboratory tests, medical history, or other assessments, which, in the opinion of the investigator or sponsor/designee constitutes an inappropriate risk or a contraindication for participation in the trial or that could interfere with the trial’s objectives, conduct, or evaluation 3. Active neurological symptoms of SLE that are deemed severe or progressive and/or are associated with significant cognitive impairment leading to the inability to provide informed consent and/or comply with the protocol 4. Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection that in the investigator’s opinion makes the subject unsuitable to continue participation in the trial. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus, considered by the investigator to be sufficiently controlled, would not be exclusionary. 5. Diagnosis of any demyelinating disease, such as, but not restricted to, MS or optic neuritis 6. Pregnancy
Countries
Germany, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed