A Phase 1 interventional study of secukinumab (AIN457) in Healthy and Psoriasis, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Austria. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Basic science
The proposed exploratory study aims to understand the in vivo skin distribution properties of subcutaneously (s.c.) administered AIN457 in psoriatic and healthy skin using open flow microperfusion (OFM). The data of this study will help to understand the mode of action of AIN457 in its target tissue.
It aims to establish a technique assessing in vivo distribution of AIN457 and its metabolites in human dermal interstitial fluid (ISF) and exploring a potential pharmacodynamic effect in situ. In addition, the study will further evaluate safety and local tolerability of subcutaneously administered AIN457 and explore dermal interstitial fluid skin levels of potential disease relevant biomarkers.
The study is divided into two parts - Part I with 8 healthy volunteers (HV) to validate the method is completed and Part II with 8 psoriasis patients will start based on the outcome of Part I.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 16 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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For Part I : Healthy male and female subjects 18 to 65 years of age inclusive; For Part II: Chronic plaque-type psoriasis (with or without arthritis) diagnosed for at least 6 months before enrollment including at least one plaque accessible for OFM with at least moderate severity ; Key exclusion criteria for Part I and Part II: Women of child-bearing potential unwilling to use effective contraception; History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive TB-test at screening; For Part I: Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing For Part II: Ongoing use of concomitant psoriasis treatments. Washout periods have to be adhered to.
Other protocol-defined inclusion/exclusion criteria may apply.
secukinumab (AIN457)
Drug: secukinumab (AIN457)
anti-IL-17 antibody
Amount (ng/ml) of AIN457 in dermal interstitial fluid.
Distribution of AIN457 into dermal interstitial fluid after single subcutaneous administration of AIN457 in healthy subjects and in psoriatic patients
Time frame: Day 8
Amount (ng/ml) of AIN457 in dermal interstitial fluid.
Distribution of AIN457 into dermal interstitial fluid after single subcutaneous administration of AIN457 in healthy subjects and in psoriatic patients
Time frame: Day 15
Number of adverse events to measure Safety of subcutaneously administered AIN457 in healthy volunteers and psoriatic patients
Safety of AIN457 s.c. injection will be documented as numbers of adverse event.
Time frame: 3 weeks
Part I only: concentration of sinistrin in serum vs. dermal interstitial fluid to confirm the ability of sinistrin to serve as reference to quantify AIN457 in dermal interstitial fluid.
Concentration of sinistrin in serum compared to dermal interstitial fluid.
Time frame: Day 8
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals