Back to resultsDistribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg (OFM ISF)
Primary Purpose
Healthy, Psoriasis
Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
secukinumab (AIN457)
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Psoriasis, interstitial fluid, open flow microperfusion, IL-17, inflammatory skin disease, scaly patches, Healthy volunteers and psoriasis patients
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AIN457
Arm Description
secukinumab (AIN457)
Outcomes
Primary Outcome Measures
Amount (ng/ml) of AIN457 in dermal interstitial fluid.
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.
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
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.
Concentration of sinistrin in serum compared to dermal interstitial fluid.
Full Information
NCT ID
NCT01539213
First Posted
December 23, 2011
Last Updated
December 6, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01539213
Brief Title
Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg
Acronym
OFM ISF
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Psoriasis
Keywords
Psoriasis, interstitial fluid, open flow microperfusion, IL-17, inflammatory skin disease, scaly patches, Healthy volunteers and psoriasis patients
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AIN457
Arm Type
Experimental
Arm Description
secukinumab (AIN457)
Intervention Type
Drug
Intervention Name(s)
secukinumab (AIN457)
Intervention Description
anti-IL-17 antibody
Primary Outcome Measure Information:
Title
Amount (ng/ml) of AIN457 in dermal interstitial fluid.
Description
Distribution of AIN457 into dermal interstitial fluid after single subcutaneous administration of AIN457 in healthy subjects and in psoriatic patients
Time Frame
Day 8
Title
Amount (ng/ml) of AIN457 in dermal interstitial fluid.
Description
Distribution of AIN457 into dermal interstitial fluid after single subcutaneous administration of AIN457 in healthy subjects and in psoriatic patients
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Number of adverse events to measure Safety of subcutaneously administered AIN457 in healthy volunteers and psoriatic patients
Description
Safety of AIN457 s.c. injection will be documented as numbers of adverse event.
Time Frame
3 weeks
Title
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.
Description
Concentration of sinistrin in serum compared to dermal interstitial fluid.
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
23607128
Citation
Abstracts of the 2013 International Investigative Dermatology Meeting. May 8-11, 2013. Edinburgh, Scotland, United Kingdom. J Invest Dermatol. 2013 May;133 Suppl 1:S1-311. No abstract available.
Results Reference
result
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10883
Description
Results for CAIN457A2225 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg
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