Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI9929 · 4 trials · 3 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.
To investigate the safety and tolerability (Adverse events, blood pressure and pulse, Electrocardiogram, Body temperature, respiratory rate, Haematology, Clinical Chemistry, Urinalysis, and physical examination) of MEDI9929 following administration of single ascending doses.
| 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. |
| MEDI9929 | EXPERIMENTAL | Solution of MEDI9929, SC |
| 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...
MEDI9929 is an investigational small molecule being studied for asthma, atopic dermatitis, and in healthy volunteers. It has been evaluated in clinical trials for inadequately controlled severe asthma in adults, mild to moderate asthma in adolescents, and atopic dermatitis in adults. The drug is not approved and remains in clinical development.
MEDI9929 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored clinical trials of the drug across multiple countries, including the United States, Japan, and several European nations. AstraZeneca is conducting the development program for this investigational therapy.
MEDI9929 has completed Phase 2 clinical trials for asthma and atopic dermatitis. It has also completed Phase 1 trials in healthy volunteers and adolescents with asthma. All four trials listed for the drug are completed, with no active trials currently ongoing. The drug remains investigational and is not FDA approved.
MEDI9929 has completed four clinical trials. NCT02054130 was a Phase 2 study in adults with inadequately controlled severe asthma. NCT02525094 was a Phase 2a study in adults with atopic dermatitis. NCT01913028 was a Phase 1 study in healthy Japanese males, and NCT02512900 was a Phase 1 study in adolescents with asthma.
Yes, MEDI9929 is also known as AMG 157. Two of its clinical trials, NCT02054130 and NCT02512900, explicitly reference AMG 157 in their titles. The drug has been studied under both names in clinical research for asthma and other conditions.
MEDI9929 has completed Phase 2 testing in adults with inadequately controlled severe asthma and Phase 1 testing in adolescents with mild to moderate asthma. The Phase 2 trial enrolled 584 participants across multiple countries. No active trials are currently listed for the drug, and it has not received regulatory approval.