Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI 545 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MEDI-545 |
| 2 | OTHER | Placebo |
| 3 | ACTIVE_COMPARATOR | MEDI-545 |
| 4 | ACTIVE_COMPARATOR | MEDI-545 |
| 5 | ACTIVE_COMPARATOR | MEDI-545 |
| Name | Type | Description |
|---|---|---|
| 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. |
| Placebo | OTHER | Dosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial. Dosage, frequency and duration: Placebo (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. |
| MEDI-545 | BIOLOGICAL | 0.3 mg/kg IV (n=6) at Study Day 0 |
Inclusion Criteria: * Male or female adults ≥ 18 years of age at the time of the first dose of study drug; * Written informed consent obtained from the patient; or patient's legal representative; * Meet at least 4 of the 11 revised ACR classification criteria for SLE (see Appendix A) (ACR,1999); * ...
MEDI 545 is an investigational monoclonal antibody being studied for chronic plaque psoriasis, lupus, systemic lupus erythematosus, and dermatomyositis or polymyositis. It is in Phase 1 clinical development for these conditions.
MEDI 545 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational monoclonal antibody.
MEDI 545 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Clinical trials are ongoing to assess its safety and tolerability in patients with conditions such as lupus and chronic plaque psoriasis.
MEDI 545 has completed two Phase 1 trials: NCT00472758 in chronic plaque psoriasis and NCT00482989 in systemic lupus erythematosus. Both trials evaluated safety and tolerability of the drug.
Yes, MEDI 545 and MEDI-545 refer to the same investigational monoclonal antibody. The drug is also referred to as MEDI 545 in clinical trial records, with the hyphenated form used in some study titles.