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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04611971 | A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2 | PHASE1 | COMPLETED | 13 | — | — | Oct 27, 2020 | May 6, 2021 | Feb 3, 2025 | 1 | Belgium |
Number of participants with presence and size of induration in active versus control at the Candin injection site compared to the intra-individual saline control injection site approximately 48 hours after Candin challenge will be reported.
| Arm | Type | Description |
|---|---|---|
| Active Arm: Benlysta + Candin | ACTIVE_COMPARATOR | Participants will receive a single dose of Candin injection intradermally along with a saline solution of 0.9% sodium chloride (NaCl), and a single dose of Benlysta injection subcutaneously. |
| Control Arm: Candin | NO_INTERVENTION | All participants will receive a single dose of Candin injection intradermally along with a single dose of saline solution of 0.9% NaCl administered intradermally and no Benlysta. |
| Name | Type | Description |
|---|---|---|
| Benlysta | DRUG | Benlysta injection will be administered subcutaneously. |
| Candin | DRUG | Candin will be administered intradermally along with NaCl solution. |
Inclusion Criteria: * Have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2, inclusive (BMI = weight/height\^2), and body weight of no less than 50 kilograms (kg) * Healthy on the basis of physical examination, medical history, and vital signs performed at screening....