Limited SclerodermaNCT01881529
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
An observational study of Limited Scleroderma and Diffuse Scleroderma, run by Gilead Sciences at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited Scleroderma, Diffuse Scleroderma
- How many people
- 29 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with documented diagnoses of scleroderma will be enrolled into one of two cohorts, depending upon the subject's diagnosis
Who may be able to join
- Over 18 years of age
- Documented diagnosis of scleroderma
- Willing and able to provide written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Australia1 site
St Vincent's Centre for Applied Medical Research
Darlinghurst, New South Wales, 2010
About this study
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.
Read the 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.
- Conditions
- Limited Scleroderma, Diffuse Scleroderma
- Keywords
- limited scleroderma, diffuse scleroderma, Sclerosis, Progressive, Limited
- Medical subject headings
- Scleroderma, Limited, Scleroderma, Diffuse, Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Limited Scleroderma | Not described | |
| Diffuse Scleroderma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summarized the number and percentage of subjects with elevated LOXL2 levels
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited SclerodermaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bittoo Kanwar, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881529
- Sponsor's protocol ID
- GS-US-321-0108
- Status last verified
- Apr 2014
- First submitted
- 5 Jun 2013
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
- ClinicalTrials.gov ID
- NCT01881529
- Acronym / sponsor ID
- GS-US-321-0108
- Conditions
- Limited Scleroderma, Diffuse Scleroderma
- Keywords
- limited scleroderma, diffuse scleroderma, Sclerosis, Progressive, Limited
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limited Scleroderma | – | – |
| Diffuse Scleroderma | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with documented diagnoses of scleroderma will be enrolled into one of two cohorts, depending upon the subject's diagnosis
Key inclusion criteria (3 listed)
- Over 18 years of age
- Documented diagnosis of scleroderma
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Summarized the number and percentage of subjects with elevated LOXL2 levels
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bittoo Kanwar, MD study director
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limited Scleroderma and Diffuse Scleroderma, run by Gilead Sciences at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summarized the number and percentage of subjects with elevated LOXL2 levels (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014; AzTrials last refreshed its copy on 29 Oct 2026.