Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients

Study Overview
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Brief Summary
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This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.

Official Title
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A Single Center, Open Label Exploratory Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Topically Administered BCT194 in Dermal Interstitial Fluid in Psoriatic Patients Using Open Flow Microperfusion

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: BCT194


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male patients and post menopausal or surgically sterile female patients aged 18 - 75 years. Diagnosis of stable plaque psoriasis (with or without arthritis); diagnosed or history of psoriasis for at least 6 months prior to screening Psoriatic plaques accessible for microperfusion at body sites (e.g. trunk) convenient for the patients. Exclusion criteria: Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular. Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium). Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus. Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, psychiatric, or other disease which would make the patient unsuitable for the trial. Presence of major chronic inflammatory autoimmune diseases like rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematosus. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCT194<br> | Drug: BCT194<br>* Topically applied BCT194 cream (0.5%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Maximum dermal interstitial concentration of BCT194 | Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints | Day 1 and day 8 | 
| Area under the curve interstitial concentrations of BCT194 | Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints | day 1 and day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha) | Interstitial fluid will be collected and concentrations of Tumor Necrosis Factor alpha determined determined on Day 1 and Day 8 at several timepoints | day 1 and day 8 | 
| Change in plaque PASI scores of psoriasis lesions | Treatment areas will be assessed clinically at baseline and Day 8 | day 1 and day 8 | 
| BCT194 concentrations in skin biopsies | Biopsies of lesional and nonlesional skin will be collected 4 hours post dose on Day 1 and Day 8 for measurement of BCT194 concentration. | day 1 and day 8 | 
| Change in Local tolerability score | Local tolerability assessed using a validated score (0-4) for each treatment area Safety Issue: Treatment sites will be visually assessed for visible reaction to the treatment. | Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Stable plaque psoriasis, lesions, TNF-alpha, BCT194