The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.
Subjects will receive matching placebo.
Charité Research Organisation GmbH
Berlin, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16
Time frame: Up to 16 weeks
Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration
Time frame: Up to 16 weeks
Serum Concentration of JNJ-56022473
Time frame: Up to 16 weeks
Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies
Time frame: Up to 16 weeks
Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR)
Whole blood samples collected from subjects enrolled in this study will be examined by qPCR to assess the ability of JNJ-56022473 to initiate the expected effect on target cells.
Time frame: Up to 38 weeks
Counts of Target Cells
Counts of target cells will be measured by flow cytometry from whole blood.
Time frame: Up to 38 weeks
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