Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Blisibimod
A-623 · 4 trials · 2 indications
Safety assessments such as AEs, SAEs, vital signs, ECG, clinical chemistry, hematology, and immunogenicity will be analyzed in a descriptive manner and will include infections, malignancies, injection site reactions and immunogenicity, neuropsychiatric events, and deaths
The % of subjects with SLE response compared with baseline at the time of assessment
| Arm | Type | Description |
|---|---|---|
| blisibimod weekly dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Blisibimod | EXPERIMENTAL | Blisibimod administered subcutaneously |
| A-623 high dose weekly | EXPERIMENTAL | High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study |
| A-623 low dose weekly | EXPERIMENTAL | Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study |
| A-623 high dose every 4 weeks | EXPERIMENTAL | High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study |
| Name | Type | Description |
|---|---|---|
| blisibimod | DRUG | blisibimod administered via subcutaneous injection every week for 52 weeks |
| Placebo | DRUG | Placebo will be administered weekly via subcutaneous injection for 52 weeks |
| A-623 | DRUG | High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study |
| Placebo Comparator | OTHER | Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks |
Inclusion Criteria: * Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology * Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA) * Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid the...
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