Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cosentyx · 2 trials · 1 indication
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...
Cosentyx is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with two completed trials evaluating its use as a challenge agent in healthy volunteers. The drug is not approved for any indication and remains under investigation.
Cosentyx is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical trials, and Johnson & Johnson is responsible for its development and clinical testing.
Cosentyx is in Phase 1 clinical development. It has completed two Phase 1 trials in healthy participants, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities for any use.
Cosentyx has been studied in two completed Phase 1 clinical trials: NCT04589026 and NCT05522517. Both trials were conducted in Belgium and enrolled healthy participants aged 18 years and older. The trials were not double-blinded and used a no-treatment control design.
Cosentyx is being studied as a challenge agent in trials that validate the use of Candin. The trials are titled 'A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants.' Cosentyx itself is not the same as Candin, but it is being tested in this context.