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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: BCT194

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCT194	Drug: BCT194; Topically applied BCT194 cream (0.5%)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): February 28, 2012

Study Record Updates

• Last Update Posted (Estimate): February 28, 2012
• Last Update Submitted That Met QC Criteria: February 27, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Psoriasis; TNF-alpha; lesions; Stable plaque psoriasis; BCT194
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CBCT194A2102; 2006-004690-10 (EudraCT Number)