A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 4

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Candin; Drug: Cosentyx

Study type: Interventional

Funder types: Industry

Identifiers

NCT05522517

NOPRODPANAP1004 (Other Identifier)

2022-001636-29 (EudraCT Number)

CR109261

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)
• Otherwise healthy on the basis of physical examination, medical history, and vital signs, and if required by the applicable Intervention Specific Appendix (ISA), a 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant or consistent with the disease of interest, as specified in the applicable ISA. This determination must be recorded in the participant's source documents and initialed by the investigator
• Otherwise 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
• Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 [COVID-19]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to administration of study intervention
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 20 weeks after 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, unless consistent with the underlying disease of interest in the study population, if applicable
• History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia, unless consistent with the underlying disease of interest in the study population, if applicable. 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 (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Known allergies, hypersensitivity, or intolerance to secukinumab or its excipients
• Has surgery planned within 20 weeks after the study intervention administration

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Candin + Cosentyx

Experimental group

Description:

Participants will receive a single dose of candin injection intradermally on Day 6 along with a single dose of saline solution injection of 0.9 percent (%) sodium chloride (NaCl) and a single dose of Cosentyx injection subcutaneously on Day 1.

Treatment:

Drug: Candin

Drug: Cosentyx

Candin Challenge

No Intervention group

Description:

All participants will receive single dose of candin injection intradermally on Day 6 along with a single dose of saline solution injection of 0.9 percent (%) sodium chloride (NaCl) administered intradermally and no Cosentyx.