Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI-528/kg · 5 trials · 2 indications
Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Number of participants with troponin levels greater than upper limit of normal
Number of participants with abnormal clinically significant ECG results
Number of participants experiencing abnormal clinically significant MRI results
Number of participants experiencing serious adverse events
Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Number of participants with clinically significant changes from baseline in neurologic exam
Number of participants with changes from baseline in the Day 28 MRI of the brain
| Arm | Type | Description |
|---|---|---|
| MEDI528 30 mg | EXPERIMENTAL | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 100 mg | EXPERIMENTAL | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 300 mg | EXPERIMENTAL | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Placebo | EXPERIMENTAL | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 0.3 mg/kg | EXPERIMENTAL | MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 1 mg/kg | EXPERIMENTAL | MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 3 mg/kg | EXPERIMENTAL | MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 9 mg/kg | EXPERIMENTAL | MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion |
| MEDI-528 0.3 mg/kg | EXPERIMENTAL | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose |
| MEDI-528 1 mg/kg | EXPERIMENTAL | MEDI-528 (1 mg/kg) administered as a single, SC dose |
| MEDI-528 3 mg/kg | EXPERIMENTAL | MEDI-528 (3 mg/kg) administered as a single, SC dose |
| MEDI-528 9 mg/kg | EXPERIMENTAL | MEDI-528 (9 mg/kg) administered as a single, SC dose |
| Name | Type | Description |
|---|---|---|
| MEDI528 30 mg | BIOLOGICAL | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 100 mg | BIOLOGICAL | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 300 mg | BIOLOGICAL | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Placebo | OTHER | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 0.3 mg/kg | BIOLOGICAL | MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 1 mg/kg | BIOLOGICAL | MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 3 mg/kg | BIOLOGICAL | MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI-528 9 mg/kg | BIOLOGICAL | MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion |
| MEDI-528 0.3 mg/kg | BIOLOGICAL | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose |
| MEDI-528 1 mg/kg | BIOLOGICAL | MEDI-528 (1 mg/kg) administered as a single, SC dose |
| MEDI-528 3 mg/kg | BIOLOGICAL | MEDI-528 (3 mg/kg) administered as a single, SC dose |
Inclusion Criteria Subjects must meet all of the following criteria: 1. Male or female 2. Age 18 through 65 years at the time of screening 3. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including scr...
MEDI-528/kg is an investigational monoclonal antibody being developed for asthma. It has been studied in adults with asthma, including mild persistent asthma and atopic asthma, as well as in healthy volunteers for safety and pharmacokinetic evaluations. It is not approved and remains in clinical development.
MEDI-528/kg is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored clinical trials of the drug in asthma across multiple countries, including the United States, Canada, and several others.
MEDI-528/kg is in Phase 2 clinical development. All four completed trials were Phase 1 or Phase 2 studies, with the most advanced being Phase 2 trials evaluating efficacy and safety in adults with asthma. It is investigational and not FDA approved.
MEDI-528/kg has completed four clinical trials: NCT00192296 (Phase 1, healthy volunteers), NCT00394654 (Phase 2, atopic asthma), NCT00507130 (Phase 2, mild persistent asthma), and NCT00968669 (Phase 2, asthma in adults). All trials are completed with a total enrollment of 419 participants.
MEDI-528/kg is a variant name for MEDI-528, the same investigational monoclonal antibody. The drug is referred to as MEDI-528 in clinical trial records, with MEDI-528/kg used as an alternative designation in some contexts.