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

Healthy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539213
• Other study ID #: CAIN457A2225
• Secondary ID: 2011-002929-21
• Status: Completed
• Phase: Phase 1
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Psoriasis

Intervention

Drug:
• secukinumab (AIN457)
anti-IL-17 antibody

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 8
Primary	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	Day 15
Secondary	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.	3 weeks
Secondary	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.	Day 8

External Links

•   Results for CAIN457A2225 can be found on the Novartis Clinical Trial Results Website