This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
subcutaneous administration every 2 weeks from week 0 to week 50
subcutaneous administration every two weeks from week 0 to week 50
Research Site
Thousand Oaks, California, United States
Research Site
Orlando, Florida, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Debrecen, Hungary
Research Site
Zalaegerszeg, Hungary
Research Site
Bydgoszcz, Poland
Research Site
Warsaw, Poland
...and 4 more locations
Maximum Concentration of Anifrolumab in Serum After First Dose
Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.
Time frame: Week 0
Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab
Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).
Time frame: Week 12
21-gene Type 1 IFN Signature Score (Fold-change)
21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.
Time frame: Week 12
21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change)
21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)\*100) for the 21 genes. At a population level, the results are presented as mean the above.
Time frame: Week 12
Number of Participants With Antidrug Antibody (ADA)
Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA)
Time frame: Baseline to Week 52
Number of Participants With Neutralizing Antibodies (nAb)
Incidence of detectable nAb in post-baseline ADA positive participants.
Time frame: Baseline to Week 52
Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI)
Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.
Time frame: Baseline to Week 52
Change From Baseline for Vital Signs
Change from baseline for vital signs.
Time frame: Baseline to Week 60
Change From Baseline for Physical Examination
Physical examination is reported as change from baseline in body weight.
Time frame: Baseline to Week 60
Change From Baseline for 12-lead ECG
The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant \[NCS\]), abnormal (clinically significant \[CS\]), or not done.
Time frame: Baseline to Week 52
Value of Haemoglobin Blood Test to Detect Change From Baseline
Change from baseline in haemoglobin blood tests are reported.
Time frame: Baseline to Week 60
Value of Haematology Blood Tests to Detect Change From Baseline
Change from baseline in haematology blood tests (leucocytes \[particle concentration\], platelets \[particle concentration\]) are reported.
Time frame: Baseline to Week 60
Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline
Change from baseline in protein-creatinine ratio urinalysis tests are reported.
Time frame: Baseline to Week 60
Value of Total Protein Urinalysis Test to Detect Change From Baseline
Change from baseline in total protein urinalysis tests are reported.
Time frame: Baseline to Week 60
Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)
Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase) are reported.
Time frame: Baseline to Week 60
Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)
Change from baseline in clinical creatinine chemistry blood tests (serum) are reported.
Time frame: Baseline to Week 60
Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline
Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported.
Time frame: Baseline to Week 60
Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline
Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported.
Time frame: Baseline to Week 60
Number of Participants With Positive Hepatitis B Core Antibody Post-baseline.
Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening.
Time frame: Baseline to Week 60
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.