Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI 545 · 6 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| MEDI-545 1.0 mg/kg | EXPERIMENTAL | Cohort 1 |
| MEDI-545 3.0 mg/kg | EXPERIMENTAL | Cohort 2 |
| MEDI-545 10.0 mg/kg | EXPERIMENTAL | Cohort 3 |
| MEDI-545 100 mg | EXPERIMENTAL | Cohort 4 |
| MEDI-545 600 mg | EXPERIMENTAL | Cohort 5 |
| MEDI-545 1,200 mg | EXPERIMENTAL | Cohort 6 |
| 1 | EXPERIMENTAL | MEDI-545 |
| 2 | EXPERIMENTAL | MEDI-545 |
| 3 | EXPERIMENTAL | MEDI-545 |
| 4 | EXPERIMENTAL | MEDI-545 |
| 5 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| MEDI-545 | DRUG | Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses. |
| MEDI-545 600 | DRUG | Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses. |
| Placebo | DRUG | SC Placebo every week × 13 doses |
| MEDI 545 | BIOLOGICAL | MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial. Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks. |
Inclusion Criteria: * Patients must have previously met ≥4 of the 11 revised ACR criteria * Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening * Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or h...
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MEDI 545 is an investigational monoclonal antibody developed by AstraZeneca PLC. It has been studied in autoimmune and inflammatory conditions, including systemic lupus erythematosus, lupus, dermatomyositis or polymyositis, and chronic plaque psoriasis. It is not an approved therapy and remains in clinical development.
MEDI 545 has been evaluated for the treatment of systemic lupus erythematosus, lupus, dermatomyositis or polymyositis, and chronic plaque psoriasis. These studies examined safety and tolerability in adults. MEDI 545 is investigational and has not been approved for any indication.
MEDI 545 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the clinical studies of the antibody in lupus, dermatomyositis or polymyositis, and related autoimmune conditions.
MEDI 545 is in Phase 1 development. Its completed studies include a Phase 1 trial in dermatomyositis or polymyositis and a Phase 1 trial in systemic lupus erythematosus, along with Phase 2 studies in lupus. No active trials are currently listed.
MEDI 545 has been studied in completed trials including NCT00482989 and NCT01031836 in systemic lupus erythematosus, NCT00657189 in lupus, and NCT00533091 in dermatomyositis or polymyositis. These trials enrolled a total of 228 participants across the United States, Japan, Argentina, Brazil, and Chile.
Yes, MEDI 545 and MEDI-545 refer to the same investigational monoclonal antibody developed by AstraZeneca PLC. The two spellings are alternative names for the same drug asset studied in lupus, dermatomyositis or polymyositis, and chronic plaque psoriasis.