Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Efavaleukin alfa · 2 trials · 2 indications
Blood samples were collected to determine PK parameters.
Blood samples were collected to determine PK parameters.
Blood samples were collected to determine PK parameters.
Blood samples were collected to determine PK parameters.
A TEAE was defined as any adverse event (AE) starting on or after the first dose of investigational product through to the safety follow-up visit. Any clinically significant changes in physical examinations, vital signs, and clinical laboratory test results were recorded as AEs.
| Arm | Type | Description |
|---|---|---|
| Group 1: Chinese participants - efavaleukin alfa dose level 1 | EXPERIMENTAL | Chinese participants will receive a single dose of efavaleukin alfa at dose level 1. |
| Group 2: Chinese participants - efavaleukin alfa dose level 2 | EXPERIMENTAL | Chinese participants will receive a single dose of efavaleukin alfa at dose level 2. |
| Group 3: Japanese participants - efavaleukin alfa dose level 2 | EXPERIMENTAL | Japanese participants will receive a single dose of efavaleukin alfa at dose level 2. |
| Group 4: Caucasian participants - efavaleukin alfa dose level 2 | EXPERIMENTAL | Caucasian participants will receive a single dose of efavaleukin alfa at dose level 2. |
| Efavaleukin Alfa | EXPERIMENTAL | Approximately 29 participants will be randomized in a 5:2 ratio (cohorts 1, 2, and 3) or in a 3:1 ratio (cohorts 4 and 5) to Efavaleukin Alfa or placebo in addition to standard of care therapy. Efavaleukin Alfa or placebo will be administered either weekly (QW) or biweekly (Q2W). |
| Placebo | PLACEBO_COMPARATOR | Approximately 29 participants will be randomized in a 5:2 ratio (cohorts 1, 2, and 3) or in a 3:1 ratio (cohorts 4 and 5) to Efavaleukin Alfa or placebo in addition to standard of care therapy. Efavaleukin Alfa or placebo will be administered either weekly (QW) or biweekly (Q2W). |
| Name | Type | Description |
|---|---|---|
| Efavaleukin alfa | DRUG | Administered as a single dose SC injection. |
| Placebo | DRUG | The placebo will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm. |
Inclusion Criteria: * Healthy male or female participants, between 18 and 55 years of age (inclusive) at the time of Screening. * Chinese, Japanese, or Caucasian participant: * Chinese participants must be of Chinese ancestry (4 grandparents and biological parents). * Japanese participants mus...
Efavaleukin Alfa is an investigational drug being developed for Systemic Lupus Erythematosus and other inflammatory diseases. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Efavaleukin Alfa is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 1 clinical trials.
Efavaleukin Alfa is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in participants with Systemic Lupus Erythematosus and another in healthy volunteers. The drug remains investigational and is not yet approved.
Efavaleukin Alfa has been studied in two completed Phase 1 trials. NCT03451422 evaluated safety and tolerability in 35 participants with Systemic Lupus Erythematosus across the US, France, Germany, and Poland. NCT04987333 studied the drug in 32 healthy Chinese, Japanese, and Caucasian participants in the UK.
Efavaleukin Alfa is a distinct investigational drug developed by Amgen. No alternative names for this drug have been reported in clinical trial registries.