Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg (OFM ISF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01539213
First received: December 23, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Psoriasis
Drug: secukinumab (AIN457)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Exploratory Study to Investigate the Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid Using Open Flow Microperfusion After a Single Subcutaneous Administration of 300 mg in Healthy Subjects and Psoriatic Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Amount (ng/ml) of AIN457 in dermal interstitial fluid. [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    Distribution of AIN457 into dermal interstitial fluid after single subcutaneous administration of AIN457 in healthy subjects and in psoriatic patients

  • Amount (ng/ml) of AIN457 in dermal interstitial fluid. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Distribution of AIN457 into dermal interstitial fluid after single subcutaneous administration of AIN457 in healthy subjects and in psoriatic patients


Secondary Outcome Measures:
  • Number of adverse events to measure Safety of subcutaneously administered AIN457 in healthy volunteers and psoriatic patients [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Safety of AIN457 s.c. injection will be documented as numbers of adverse event.

  • 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. [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    Concentration of sinistrin in serum compared to dermal interstitial fluid.


Enrollment: 16
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457
secukinumab (AIN457)
Drug: secukinumab (AIN457)
anti-IL-17 antibody

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539213

Locations
Austria
Novartis Investigative Site
Graz, Austria, A-8036
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications:
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01539213     History of Changes
Other Study ID Numbers: CAIN457A2225, 2011-002929-21
Study First Received: December 23, 2011
Last Updated: June 23, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Novartis:
Psoriasis
interstitial fluid
open flow microperfusion
IL-17
inflammatory skin disease
scaly patches
Healthy volunteers and psoriasis patients

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014