A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2

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: NCT04611971
• Other study ID #: CR108910
• Secondary ID: 2020-002481-14NO
• Status: Completed
• Phase: Phase 1
• Start date: October 27, 2020
• Est. completion date: May 6, 2021

Study information

• Verified date: June 2021
• 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: 13
• Est. completion date: May 6, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and 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

• Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example, nicotine patch) for 3 months prior to screening

• Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) coronavirus disease 2019 (COVID-19) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to administration of study intervention

• A woman must be: a) not of childbearing potential; or b) of childbearing potential and practicing a highly effective method of contraception (failure rate of less than [<] 1 percent [%] per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 4 months after study intervention administration - the end of relevant systemic exposure. The investigator should evaluate the potential for contraceptive method failure (example, noncompliance, recently initiated) in relationship to the study intervention administration

Exclusion Criteria:

• History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances

• Known allergies, hypersensitivity, or intolerance to Candin or its excipients

• Has an active, acute or chronic infection

• has a history of psychiatric disorders (depression, suicidal ideation and/or behavior including suicides)

• Has had prior exposure to belimumab or other B-cell activating factor (BAFF) inhibitors, such as tabalumab, atacicept, and telitacicept

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Benlysta
Benlysta injection will be administered subcutaneously.
• Candin
Candin will be administered intradermally along with NaCl solution.

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 8
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 2 months
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.	Up to 2 months
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.	Up to 2 months