Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE) (ReLATE)

• ClinicalTrials.gov Identifier: NCT05845593
• Recruitment Status: Recruiting
• First Posted: May 6, 2023
• Last Update Posted: May 3, 2024
• Sponsor: Ampel BioSolutions, LLC
• Information provided by (Responsible Party): Ampel BioSolutions, LLC

Tracking Information

• First Submitted Date: April 4, 2023
• First Posted Date: May 6, 2023
• Last Update Posted Date: May 3, 2024
• Actual Study Start Date: December 19, 2023
• Estimated Primary Completion Date: December 10, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 25, 2023)

• LuGENE clinical decision support relative to clinical disease activity [ Time Frame: 16 months ]
  The primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical activity (SLEDAI score) Physician Global Assessment (PGA).
• LuGENE clinical decision support relative to lab measures [ Time Frame: 16 months ]
  The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE® with standard laboratory measures of lupus (ANA, anti-DNA, anti-RNP and complement components C3 and C4)
• LuGENE clinical decision support relative to PROs [ Time Frame: 16 months ]
  The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE with standard evaluation of patient reported outcomes using standard instruments capturing pain, fatigue and Health-Related Quality of Life.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 25, 2023)

• LuGENE score correlation to Immune Function with Biomarker endpoint: [ Time Frame: 16 months ]
  The association of the LuGENE Score with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).
• LuGENE score correlation to Clinical Feature endpoint: [ Time Frame: 16 months ]
  The association of the LuGENE Score with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)
• LuGENE score correlation to Quality of Life PROs endpoint: [ Time Frame: 16 months ]
  The association of the LuGENE Score with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA))
• LuGENE subset membership correlation to Immune Function with Biomarker endpoint: [ Time Frame: 16 months ]
  The association of the LuGENE® determined subset membership with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).
• LuGENE subset membership correlation to Clinical Feature endpoint: [ Time Frame: 16 months ]
  The association of the LuGENE® determined subset membership with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)
• LuGENE subset membership correlation to Quality of Life PROs endpoint: [ Time Frame: 16 months ]
  The association of the LuGENE® determined subset membership with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA))
• LuGENE profile correlation to Immune Function with Biomarker endpoint: [ Time Frame: 16 months ]
  The association of the LuGENE® profile with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).
• LuGENE profile correlation to Clinical Feature endpoint: [ Time Frame: 16 months ]
  The association of the LuGENE® profile with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA)
• LuGENE profile correlation to Quality of Life PROs endpoint: [ Time Frame: 16 months ]
  The association of the LuGENE® profile with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA))

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: April 25, 2023)

Physician use and satisfaction [ Time Frame: 16 months ]

Evaluate the patterns of physician use and opinion of value of LuGENE® using a focused questionnaire created for this trial

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
• Official Title: 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)
• Brief Summary: This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life. The test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously. This trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of LuGENE® laboratory results do not exceed more than 7 business days.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Future Research Plasma

• Sampling Method: Non-Probability Sample
• Study Population: Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus
• Condition: Lupus Erythematosus, Systemic

Intervention

Other: Decision Support Test

LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE

Study Groups/Cohorts

Group 1

Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus

Intervention: Other: Decision Support Test

• Publications *: Hubbard EL, Bachali P, Kingsmore KM, He Y, Catalina MD, Grammer AC, Lipsky PE. Analysis of transcriptomic features reveals molecular endotypes of SLE with clinical implications. Genome Med. 2023 Oct 16;15(1):84. doi: 10.1186/s13073-023-01237-9. Erratum In: Genome Med. 2023 Dec 13;15(1):113.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 25, 2023): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 5, 2025
• Estimated Primary Completion Date: December 10, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Claire Dykas; 434-296-2675; claire.dykas@ampelbiosolutions.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05845593
• Other Study ID Numbers: AMP-005
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ampel BioSolutions, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Ampel BioSolutions, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ampel BioSolutions, LLC
• Verification Date: May 2024