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

NCT04985955 | Completed Phase 1

• 4 other identifiers: CR1090202020-006066-37NOPRODPANAP1003PLATFORMPANAP1001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response at the site of Candin intradermal injection in the presence of a targeted immune pathway inhibitor.

Conditions

Healthy

Outcome Measures

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.

  Day 5

Secondary Outcomes (3)

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

  Up to 6 weeks

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

  Up to 6 weeks

• 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

  Up to 6 weeks

Study Arms (2)

Candin + Tofacitinib

EXPERIMENTAL

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

Candin Challenge

NO INTERVENTION

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

Tofacitinib DRUG

Tofacitinib tablet will be administered orally.

Also known as: Xeljanz

Candin + Tofacitinib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
• Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
• Must sign an informed consent forms (ICFs) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after the last dose of study intervention

You may not qualify if:

• History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances
• History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Has experienced a recent single dermatomal herpes zoster eruption within the past 6 months or has had multi-dermatomal herpes zoster or central nervous system zoster within the past 5 years
• Has surgery planned within 30 days after study intervention administration

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

tofacitinib

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 2, 2021
• Study Start: July 30, 2021
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)