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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05522517 | A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 4 | PHASE1 | COMPLETED | 20 | — | — | Aug 22, 2022 | Nov 2, 2022 | Feb 3, 2025 | 1 | Belgium |
| NCT04589026 | A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 1 | PHASE1 | COMPLETED | 12 | — | — | Oct 21, 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 between 6 and 96 hours after Candin challenge will be reported.
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 |
|---|---|---|
| Candin + Cosentyx | EXPERIMENTAL | Participants will receive a single dose of candin injection intradermally on Day 6 along with a single dose of saline solution injection of 0.9 percent (%) sodium chloride (NaCl) and a single dose of Cosentyx injection subcutaneously on Day 1. |
| Candin Challenge | NO_INTERVENTION | All participants will receive single dose of candin injection intradermally on Day 6 along with a single dose of saline solution injection of 0.9 percent (%) sodium chloride (NaCl) administered intradermally and no Cosentyx. |
| Active Arm: Candin + Consentyx | 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 Cosentyx injection subcutaneously. |
| Control Arm: Candin | NO_INTERVENTION | All participants will receive a single dose of Candin injection intradermally along with a saline solution of 0.9% NaCl, and no Cosentyx. |
| Name | Type | Description |
|---|---|---|
| Cosentyx | DRUG | Cosentyx injection will be administered subcutaneously. |
| Candin | DRUG | Candin will be administered interadermally along with NaCl solution. |
Inclusion Criteria: * Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of no less than 50 kilograms (kg) * Otherwise healthy on the basis of physical examination, medical history, and vital signs, and if requi...