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

NCT04611971 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1089102020-002481-14NOPRODPANAP1002
• Study Type: interventional
• Target: 13
• 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 8

Secondary Outcomes (3)

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

  Up to 2 months

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

  Up to 2 months

• 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 2 months

Study Arms (2)

Active Arm: Benlysta + Candin

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 Benlysta injection subcutaneously.

Drug: Benlysta; Drug: Candin

Control Arm: Candin

NO INTERVENTION

All participants will receive a single dose of Candin injection intradermally along with a single dose of saline solution of 0.9% NaCl administered intradermally and no Benlysta.

Interventions

Benlysta DRUG

Benlysta injection will be administered subcutaneously.

Also known as: Belimumab

Active Arm: Benlysta + Candin

Candin DRUG

Candin will be administered intradermally along with NaCl solution.

Active Arm: Benlysta + Candin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

belimumab

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: October 29, 2020
• First Posted: November 2, 2020
• Study Start: October 27, 2020
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)