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

NCT04589026 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1089082020-002480-59NOPRODPANAP1001
• Study Type: interventional
• Target: 12
• 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% or More in the Active Arm Versus the Control Arm

  Up to 2 months

Study Arms (2)

Active Arm: Candin + Consentyx

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 Cosentyx injection subcutaneously.

Drug: Cosentyx; Drug: Candin

Control Arm: Candin

NO INTERVENTION

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

Interventions

Cosentyx DRUG

Cosentyx injection will be administered subcutaneously.

Also known as: Secukinumab

Active Arm: Candin + Consentyx

Candin DRUG

Candin will be administered interadermally along with NaCl solution.

Active Arm: Candin + Consentyx

Eligibility Criteria

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

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

secukinumab

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 13, 2020
• First Posted: October 19, 2020
• Study Start: October 21, 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)