The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Participants will receive cevostamab IV as per the schedule given in the protocol.
Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Hospital Universitario Virgen Macarena
Seville, Spain
RECRUITINGPercentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 52 weeks
Serum Concentration of Cevostamab
Time frame: Up to approximately 52 weeks
Area Under the Concentration-Time Curve (AUC) of Cevostamab
Time frame: Up to approximately 52 weeks
Maximum Observed Serum Concentration (Cmax) of Cevostamab
Time frame: Up to approximately 52 weeks
Minimum Observed Serum Concentration (Cmin) of Cevostamab
Time frame: Up to approximately 52 weeks
Clearance (CL) of Cevostamab
Time frame: Up to approximately 52 weeks
Volume of Distribution at Steady State (Vdss) of Cevostamab
Time frame: Up to approximately 52 weeks
Change from Baseline in the Presence Anti-Drug Antibodies (ADAs)
Time frame: Up to approximately 52 weeks
Reference Study ID Number: GA46280 https://forpatients.roche.com/ No attachments to email below.
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