Examining the LuGENE® Blood Test in Patients with Lupus
An Open Label Multicenter Study to Assess the Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With Systemic Lupus Erythematosus (SLE)
This study is testing a new blood test called LuGENE® to see how it relates to symptoms and lab results in people with lupus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ampel BioSolutions, LLC Industry-sponsored |
| Locations | 11 sites (Phoenix, Arizona and 10 other locations) |
| Trial ID | NCT05845593 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between the LuGENE® multiparameter transcriptomics blood test and various clinical and laboratory features in patients diagnosed with systemic lupus erythematosus (SLE). Participants will undergo the LuGENE® test alongside standard evaluations, including SLEDAI scores and laboratory measures such as ANA and anti-DNA antibodies. The study will also assess patient-reported outcomes related to pain, fatigue, and quality of life. A pilot phase will involve approximately 10 subjects across 2-3 sites to ensure timely delivery of test results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of systemic lupus erythematosus or incomplete lupus who are on a stable treatment regimen.
Not a fit: Patients with significant unstable or uncontrolled diseases unrelated to SLE or those who have recently received high doses of glucocorticoids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of lupus and improve patient management through more personalized treatment approaches.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in utilizing transcriptomic data for better understanding and managing autoimmune diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female aged at least 18 years old. 2. Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation 3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician 4. On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing Exclusion Criteria: 1. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk 2. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month 3. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline 4. Pregnant or lactating. 5. Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer 6. Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test
Where this trial is running
Phoenix, Arizona and 10 other locations
- Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States (Not_yet_recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Providence St. John's Health Center - Rheumatology — Santa Monica, California, United States (Not_yet_recruiting)
- Yale School of Medicine — New Haven, Connecticut, United States (Not_yet_recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
- University of Maryland School of Medicine — Baltimore, Maryland, United States (Not_yet_recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
- Feinstein Institute for Medical Research — Manhasset, New York, United States (Recruiting)
- The Hospital for Special Surgery — New York, New York, United States (Not_yet_recruiting)
- Arthritis and Osteoporosis Consultants of the Carolinas — Charlotte, North Carolina, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Claire Dykas
- Email: claire.dykas@ampelbiosolutions.com
- Phone: 434-296-2675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.