| Primary | 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. | All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Week 0 | | | | ID | Title | Description |
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| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00014.058± 49.8151
- OG00128.115± 74.4916
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| Primary | 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). | All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 |
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| Primary | 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. | All participants who are 21-gene IFN test high at baseline. | Posted | | Mean | Standard Deviation | fold change | | Week 12 | | | | ID | Title | Description |
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| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
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| Primary | 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. | All participants who are 21-gene IFN test high at baseline. | Posted | | Mean | Standard Deviation | percentage neutralization | | Week 12 | | | | ID | Title | Description |
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| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
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| Secondary | Number of Participants With Antidrug Antibody (ADA) | Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA) | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Count of Participants | | Participants | | Baseline to Week 52 | | | | ID | Title | Description |
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| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
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| Secondary | Number of Participants With Neutralizing Antibodies (nAb) | Incidence of detectable nAb in post-baseline ADA positive participants. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Count of Participants | | Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
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| Secondary | 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. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Count of Participants | | Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
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| Secondary | Change From Baseline for Vital Signs | Change from baseline for vital signs. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 60 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
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| Secondary | Change From Baseline for Physical Examination | Physical examination is reported as change from baseline in body weight. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Mean | Standard Deviation | kilograms | | Baseline to Week 60 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
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| Secondary | 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. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Count of Participants | | Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose |
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| Secondary | Value of Haemoglobin Blood Test to Detect Change From Baseline | Change from baseline in haemoglobin blood tests are reported. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Mean | Standard Deviation | g/L | | Baseline to Week 60 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
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| Secondary | 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. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Mean | Standard Deviation | 10^9/L | | Baseline to Week 60 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose | |
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| Secondary | Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline | Change from baseline in protein-creatinine ratio urinalysis tests are reported. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Mean | Standard Deviation | g/g | | Baseline to Week 60 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
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| Secondary | Value of Total Protein Urinalysis Test to Detect Change From Baseline | Change from baseline in total protein urinalysis tests are reported. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Mean | Standard Deviation | g/L | | Baseline to Week 60 | | | | ID | Title | Description |
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| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose | Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50 |
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| Secondary | 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. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Mean | Standard Deviation | ukat/L | | Baseline to Week 60 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose | |
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| Secondary | 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. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Mean | Standard Deviation | umol/L | | Baseline to Week 60 | | | | ID | Title | Description |
|---|
| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose | |
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| Secondary | 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. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). | Posted | | Mean | Standard Deviation | mm | | Baseline to Week 60 | | | | ID | Title | Description |
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| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator | Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 |
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| Secondary | 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. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). Only participants with abnormal baseline values are included in this analysis. | Posted | | Mean | Standard Deviation | IU/mL | | Baseline to Week 60 | | | | ID | Title | Description |
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| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose |
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| Secondary | 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. | Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). No participants were positive for Hepatitis B at screening, therefore no participants were tested post-baseline. | Posted | | | | | | Baseline to Week 60 | | | | ID | Title | Description |
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| OG000 | Anifrolumab - Lower Dose | 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 | | OG001 | Anifrolumab - Higher Dose | 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 | | OG002 | Placebo Comparator to Lower Dose | Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50 | | OG003 | Placebo Comparator to Higher Dose |
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