Atacicept Demonstrating Dose RESponSe
A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
Sponsor: EMD Serono
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change from baseline (trial day 1) in SLEDAI-2K Responder Index-50 (SRI-50) at week 24 of therapy
Time frame: 24 weeks
Secondary Endpoints
Change from baseline to Week 24 in corticosteroid dose
Change from baseline in serum Complement C3 levels at week 24 in subjects with low C3 at baseline
Change from baseline in serum Complement C4 levels at week 24 in subjects with low C4 at baseline
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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 * Breastfeedin…
Read full criteria on CT.gov →✦ Analyst Commentary
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