Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01539915

Enrollment

Registered

2012-02-28

Start date

2007-04-30

Completion date

Unknown

Last updated

2012-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis, Stable plaque psoriasis, lesions, TNF-alpha, BCT194

Brief summary

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

Interventions

DRUGBCT194

Topically applied BCT194 cream (0.5%)

Study design

Allocation

Intervention model

SINGLE_GROUP

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha)	day 1 and day 8	Interstitial fluid will be collected and concentrations of Tumor Necrosis Factor alpha determined determined on Day 1 and Day 8 at several timepoints
Change in plaque PASI scores of psoriasis lesions	day 1 and day 8	Treatment areas will be assessed clinically at baseline and Day 8
BCT194 concentrations in skin biopsies	day 1 and day 8	Biopsies of lesional and nonlesional skin will be collected 4 hours post dose on Day 1 and Day 8 for measurement of BCT194 concentration.
Change in Local tolerability score	Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13	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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026