Skip to main content
OpenTrials
Completed

NCT Number: NCT01539915

Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BCT194

Drug

Topically applied BCT194 cream (0.5%)

Primary outcomes

  1. change in Maximum dermal interstitial concentration of BCT194

    Time frame: 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

  2. Area under the curve interstitial concentrations of BCT194

    Time frame: 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 outcomes

  1. Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha)

    Time frame: 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

  2. Change in plaque PASI scores of psoriasis lesions

    Time frame: day 1 and day 8

    Treatment areas will be assessed clinically at baseline and Day 8

  3. BCT194 concentrations in skin biopsies

    Time frame: 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.

  4. Change in Local tolerability score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
First posted
Feb 28, 2012
Registry last updated
Feb 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.