Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03451422 | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus | PHASE1 | COMPLETED | 35 | — | — | Apr 10, 2018 | Oct 12, 2021 | Jul 19, 2023 | 15 | United States, France +2 |
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 |
|---|---|---|
| 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 | Efavaleukin Alfa will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm. |
| Placebo | DRUG | The placebo will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm. |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age ≥ 18 years to ≤ 70 years at screening. * Fulfills diagnostic cri...