Clinical Pharmacology Unit
Merksem, 2170, Belgium
NCT Number: NCT04985955
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: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tofacitinib tablet will be administered orally.
Other names: Xeljanz
Time frame: Day 5
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 6 weeks
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 6 weeks
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. Treatment-emergent SAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state.
Time frame: Up to 6 weeks
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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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
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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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