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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06916806 | A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | PHASE1 | RECRUITING | 72 | — | — | May 1, 2025 | Sep 15, 2027 | May 27, 2026 | 37 | United States, Canada +8 |
Number and percentage of participants with AEs, AESIs, and SAEs
Number and percentage of participants with AEs related to IMP as assessed by the investigator
Number and percentage of participants with DLTs (dose-limiting toxicities) as defined in the study protocol.
Number and percentage of participants with SAEs leading to death.
Number and percentage of participants with AEs according ASTCT, IEC-HS, and CTCAE grades.
Number and percentage of participants with treatment-related vital signs abnormalities.
Number and percentage of participants with treatment-related clinical laboratory abnormalities.
Number and percentage of participants with abnormal ECG.
| Arm | Type | Description |
|---|---|---|
| Part 1: Single Ascending Dose with AZD5492 | EXPERIMENTAL | Participants will receive AZD5492 at an assigned dose as subcutaneous (SC) injection on Day 1. |
| Part 2: Step-Up Dosing with AZD5492 | EXPERIMENTAL | Participants will receive AZD5492 as SC injection at the priming dose determined in Part 1, on Day 1, and at a target dose, based on the emergent safety data, on Day 8. |
| Name | Type | Description |
|---|---|---|
| AZD5492 | DRUG | IMP: subcutaneous. |
Inclusion Criteria: 1. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent. 2. Diagnosis of SLE: 1. Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria for SLE 2. Positive for one or more of: anti-nuclear antibodies (titre ≥ 1...