A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

Completed

• Conditions: Limited Scleroderma; Diffuse Scleroderma

• Registration Number: NCT01881529
• Lead Sponsor: Gilead Sciences

Brief Summary

To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.

Detailed Description

Scleroderma is a chronic skin-hardening disease. There are two types of scleroderma. The first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. The second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. This study will determine if the disease is associated with an elevated expression of LOXL2 levels in tissue samples from patients.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-19
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Over 18 years of age
• Documented diagnosis of scleroderma
• Willing and able to provide written informed consent

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Exclusion Criteria

• Use of experimental therapies within 28 days prior to Screening.
• Aspirin use > 81 mg daily within 1 week prior to Screening.
• Any lab abnormality or concurrent medical condition that, in the opinion of the investigator would make the patient ineligible for the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Summarized the number and percentage of subjects with elevated LOXL2 levels	Baseline

Trial Locations

Locations (1)

St Vincent's Centre for Applied Medical Research; 🇦🇺 Darlinghurst, New South Wales, Australia