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

Healthy Clinical Trial

Official title:

A Phase 1, Single Center, Randomized, Controlled Platform Study Validating the Use of Candin as a Challenge Agent in Healthy Volunteers or Patients Given Concomitant Approved Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04985955
• Other study ID #: CR109020
• Secondary ID: 2020-006066-37NO
• Status: Completed
• Phase: Phase 1
• Start date: July 30, 2021
• Est. completion date: September 21, 2021

Study information

• Verified date: October 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 21, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tofacitinib
Tofacitinib tablet will be administered orally.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 6 weeks
Secondary	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.	Up to 6 weeks
Secondary	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.	Up to 6 weeks