Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI9929 · 3 trials · 2 indications
The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline.
Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
The pharmacokinetic (PK) parameter AUC (0 to infinity) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
The PK parameter AUC (0-t) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
The PK parameter Cmax was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
The Cmax/D is the maximum observed concentration post dose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
The Tmax is the time to maximum observed serum concentration of MEDI9929. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
The t½,z is the time measured for the serum drug concentration of MEDI9929 to decrease by one half. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
The PK parameter CL/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
The PK parameter Vss/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
| Arm | Type | Description |
|---|---|---|
| MEDI9929 280 mg | EXPERIMENTAL | Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10. |
| MEDI9929 70 mg | EXPERIMENTAL | Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. |
| MEDI9929 210 mg | EXPERIMENTAL | Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. |
| MEDI9929, 140 mg, Cohort 1 (12 to 14 years) | EXPERIMENTAL | On Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 12 to 14 years of age. |
| MEDI9929, 140 mg, Cohort 2 (15 to 17 years) | EXPERIMENTAL | On Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 15 to 17 years of age. |
| Name | Type | Description |
|---|---|---|
| MEDI9929 | BIOLOGICAL | Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10. |
| Placebo | BIOLOGICAL | Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10. |
| MEDI9929 70 mg | DRUG | Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. |
| MEDI9929 210 mg | DRUG | Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. |
| MEDI9929 280 mg | DRUG | Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. |
| MEDI9929, 140 mg | DRUG | On Day 1, two MEDI9929 subcutaneous injection of 70 mg each were given into the anterior aspect of one thigh immediately followed by the second injection into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants of 12 to 17 years of age. |
Inclusion Criteria: * AD meeting Hanifin and Rajka criteria * Age 18-75 years inclusive at screening * Atopic dermatitis that affects greater than/equal to 10% body surface area * Moderate to severe AD * Effective birth control in line with protocol details Exclusion Criteria: * Active dermatolog...
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MEDI9929 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for respiratory and inflammatory conditions. It has been studied in asthma and atopic dermatitis. The drug is in Phase 2 clinical development and has completed two controlled, double-blind trials. It is also known as AMG 157.
MEDI9929 has been studied for the treatment of asthma and atopic dermatitis. Clinical trials have evaluated it in adults with inadequately controlled severe asthma, adolescents with mild to moderate asthma, and adults with atopic dermatitis. It remains investigational and is not approved for any indication.
MEDI9929 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored Phase 1 and Phase 2 clinical trials of the drug in asthma and atopic dermatitis.
MEDI9929 is in Phase 2 clinical development. Two Phase 2 trials have been completed: one in severe asthma and one in atopic dermatitis. A Phase 1 pharmacokinetic study in adolescents with mild to moderate asthma has also been completed. The drug is investigational and has not been approved by the FDA.
MEDI9929 has been evaluated in three completed trials. NCT02054130 was a Phase 2 study in 584 adults with inadequately controlled severe asthma. NCT02525094 was a Phase 2a study in 113 adults with atopic dermatitis. NCT02512900 was a Phase 1 pharmacokinetic study in 21 adolescents with mild to moderate asthma.
Yes, MEDI9929 is also known as AMG 157. The two names refer to the same investigational drug. Some clinical trial titles and publications use the AMG 157 designation, while others use MEDI9929.