Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sifalimumab · 2 trials · 1 indication
SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points (with increased deoxyribonucleic acid \[DNA\] binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).
SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of \>=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
| Arm | Type | Description |
|---|---|---|
| Sifalimumab 200 milligram (mg) | EXPERIMENTAL | Sifalimumab 200 milligram (mg) will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
| Sifalimumab 600 mg | EXPERIMENTAL | Sifalimumab 600 mg will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
| Sifalimumab 1,200 mg | EXPERIMENTAL | Sifalimumab 1,200 mg will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
| Placebo | PLACEBO_COMPARATOR | Placebo matching to sifalimumab will be administered intravenously at a fixed dose every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
| Sifalimumab (MEDI-545) 500 or 600 milligram (mg) | EXPERIMENTAL | All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment. |
| Name | Type | Description |
|---|---|---|
| Sifalimumab 200 mg | BIOLOGICAL | Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
| Sifalimumab 600 mg | BIOLOGICAL | Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
| Sifalimumab 1,200 mg | BIOLOGICAL | Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses. |
| Placebo | OTHER | IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks |
| Sifalimumab | DRUG | All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment. |
Inclusion Criteria: - Fulfills at least 4 of American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) or elevated ds-deoxyribonucleic acid (DNA) or Sm antibody at screening - Disease history of SLE greater than or equal to...
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Sifalimumab is an investigational monoclonal antibody that was studied for the treatment of systemic lupus erythematosus, an autoimmune disease. It was evaluated in adults with lupus in Phase 2 clinical development. It is not an approved therapy; the clinical program has been completed.
Sifalimumab targets multiple interferon-alpha subtypes, including IFNA1, IFNA2, IFNA5, IFNA6, IFNA8, and IFNA10. It acts as an inhibitor of these interferon-alpha proteins. Interferon-alpha signaling is associated with the immune dysregulation seen in systemic lupus erythematosus.
Sifalimumab was developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the clinical program evaluating the antibody in systemic lupus erythematosus.
Sifalimumab reached Phase 2 clinical development for systemic lupus erythematosus. Both of its recorded trials are completed, and no trials are currently active. It is an investigational agent and has not been approved by the FDA for any indication.
Sifalimumab was studied in two completed Phase 2 trials. NCT01283139 evaluated efficacy and safety in 834 adults with systemic lupus erythematosus across 22 countries. NCT00979654 assessed long-term safety in 118 adults with systemic lupus erythematosus or myositis. Both were randomized, double-blind, and placebo-controlled.