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 drug being studied for the treatment of Systemic Lupus Erythematosus (SLE). It is being developed by AstraZeneca PLC (ticker: AZN). As of now, it is in Phase 2 clinical development and is not yet approved by regulatory authorities.
Sifalimumab is a small molecule being developed for Systemic Lupus Erythematosus. The specific molecular target of Sifalimumab has not been disclosed in the available information. It is currently in Phase 2 clinical trials to evaluate its efficacy and safety in patients with SLE.
Sifalimumab is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 2 clinical development for the treatment of Systemic Lupus Erythematosus.
Sifalimumab is in Phase 2 clinical development. It has completed two Phase 2 trials, with a total enrollment of 952 participants. Both trials were randomized, double-blind, and placebo-controlled. The drug is still investigational and has not received FDA approval.
Sifalimumab has been studied in two completed Phase 2 clinical trials. The first, NCT00979654, evaluated long-term safety in 118 adults with SLE or myositis. The second, NCT01283139, assessed efficacy and safety in 834 adults with SLE. Both trials were completed and included participants from multiple countries.
Sifalimumab is also known as MEDI-545. The clinical trial NCT00979654, which evaluated the long-term safety of MEDI-545 in adults with Systemic Lupus Erythematosus or myositis, is one of the trials for Sifalimumab. This alternative name is used in some clinical research contexts.