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

Gilead Sciences

Status: Completed

Conditions: Diffuse Scleroderma; Limited Scleroderma

Study type: Observational

Funder types: Industry

Identifiers

NCT01881529

GS-US-321-0108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

29 participants in 2 patient groups

Limited Scleroderma

Diffuse Scleroderma