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

NCT ID: NCT04611971

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2021-05-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Active Arm: Benlysta + Candin

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.

Group Type: ACTIVE_COMPARATOR

Benlysta

Intervention Type: DRUG

Benlysta injection will be administered subcutaneously.

Candin

Intervention Type: DRUG

Candin will be administered intradermally along with NaCl solution.

Control Arm: Candin

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Benlysta

Benlysta injection will be administered subcutaneously.

Intervention Type: DRUG

Candin

Candin will be administered intradermally along with NaCl solution.

Intervention Type: DRUG

Other Intervention Names

Belimumab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2020-002481-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NOPRODPANAP1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108910

Identifier Type: -

Identifier Source: org_study_id