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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01881529
Enrollment
29
Registered
2013-06-19
Start date
2013-04-30
Completion date
2014-03-31
Last updated
2014-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Scleroderma, Limited Scleroderma

Keywords

limited scleroderma, diffuse scleroderma, Sclerosis, Progressive, Limited

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.

Interventions

None listed

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Summarized the number and percentage of subjects with elevated LOXL2 levelsBaseline

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026