Clinical Pharmacology Unit
Merksem, 2170, Belgium
NCT Number: NCT04589026
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Merksem, 2170, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cosentyx injection will be administered subcutaneously.
Other names: Secukinumab
Candin will be administered interadermally along with NaCl solution.
Time frame: Day 8
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.
Time frame: Up to 2 months
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time frame: Up to 2 months
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to 2 months
Number of participants with TEAEs by MedDRA SOC with a frequency threshold of 5% or more in the active arm versus the control arm will be reported.
Janssen Research & Development, LLC
Industry
A Phase 1, Single Center, Randomized, Controlled Platform Study Validating the Use of Candin As a Challenge Agent in Healthy Volunteers or Patients Given Concomitant Approved Interventions
Acronym: PLATFORM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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