A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• Experimental
  Candin + Tofacitinib

  Participants will receive a single dose of Candin injection on forearm of 1 arm along with a saline solution injection of 0.9 percent (%) sodium chloride (NaCl) on the opposite forearm on Day 3 and oral dose of tofacitinib for 5 days.

  Drug: Tofacitinib

• No intervention
  Candin Challenge

  All participants will receive a single dose of Candin injection on forearm of 1 arm along with a saline solution injection of 0.9% NaCl on the opposite forearm on Day 3.

Interventions

• DrugTofacitinib

  Tofacitinib tablet will be administered orally.

  Also known as: Xeljanz

Primary outcomes

1. 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

   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.

   Time frame: Day 5

Secondary outcomes

1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) in the Active Arm Versus the Control Arm

   An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

   Time frame: Up to 6 weeks

2. Number of Participants with Treatment-emergent Serious Adverse Events (SAEs) in the Active Arm Versus the Control Arm

   A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state.

   Time frame: Up to 6 weeks

3. Number of Participants with TEAEs by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More in the Active Arm Versus the Control Arm

   Number of participants with TEAEs by MedDRA SOC with a frequency threshold of 5% or more in the active arm versus the control arm will be reported. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

   Time frame: Up to 6 weeks

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu