A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 1

NCT ID: NCT04589026

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• 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: Candin + Consentyx

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 Cosentyx injection subcutaneously.

Group Type: ACTIVE_COMPARATOR

Cosentyx

Intervention Type: DRUG

Cosentyx injection will be administered subcutaneously.

Candin

Intervention Type: DRUG

Candin will be administered interadermally along with NaCl solution.

Control Arm: Candin

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cosentyx

Cosentyx injection will be administered subcutaneously.

Intervention Type: DRUG

Candin

Candin will be administered interadermally along with NaCl solution.

Intervention Type: DRUG

Other Intervention Names

Secukinumab

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) between 18 and 30 kilogram per square centimeter (kg/m^2) (BMI = weight/height^2), inclusive, and a body weight of no less than 50 kg
• Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (eg, 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
• Are considered eligible according to the following tuberculosis (TB) screening criteria: have no history of latent or active TB prior to screening, have no signs or symptoms suggestive of active TB upon medical history and/or physical examination, and have had no recent close contact with a person with active TB
• Have a negative T-Spot TB test or QuantiFERON-TB test result within 28 days prior to the first administration of study intervention. A negative tuberculin skin test prior to the first study intervention administration is additionally required if the T-Spot test or QuantiFERON-TB test is not approved/registered in that country or the tuberculin skin test is mandated by local health authorities. If the test is positive, the participant will be referred for appropriate follow-up; however, these participants will not be included in the study

Exclusion Criteria

• History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances
• Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis) or has been hospitalized for a serious infection during the 6 months prior to screening
• Has received over-the-counter medications (including vitamins/multivitamins/supplements, corticosteroids, acetaminophen/paracetamol aspirin, decongestants, antihistamines, and other non-steroidal anti-inflammatory drugs), and herbal medication (including, but not limited to, herbal tea and St. John's Wort) within 2 weeks prior to first study treatment administration unless approved by the investigator and sponsor medical monitor
• Has surgery planned within 20 weeks after the study intervention administration
• Has had prior exposure to secukinumab or other interleukin-17 inhibitors, such as ixekizumab, brodalumab, bimekizumab

• 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

2020-002480-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NOPRODPANAP1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108908

Identifier Type: -

Identifier Source: org_study_id