Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus (NCT05306873) | Clinical Trial Compass
TerminatedPhase 2
Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus
Stopped: The study was closed due to slow enrollment.
United States12 participantsStarted 2022-11-30
Plain-language summary
The primary purpose of this study is to evaluate the potential effectiveness of 24 weeks of MMF within previously discovered immunologically defined subsets of SLE patients. Treatment effects will be evaluated within the individual immunologically-homogenous subsets defined at screening. This study will also explore and compare pre-randomization gene expression patterns among responders and non-responders to MMF and MMF plus voclosporin, use comprehensive immunophenotyping to study the immunologic changes that accompany treatment- induced disease improvement and to better understand immunologic changes associated with the loss of clinical response.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Aged ≥ 18 and ≤ 60 years at the time of informed consent.
✓. Meets EULAR/ACR 2019 criteria for SLE.
✓. Moderately severe, active, but non-organ threatening disease. Specifically, signs or symptoms meeting criteria for a minimum of:
Exclusion criteria
✕. 2 BILAG B (moderate) activity scores in any organ systems; or
✕. 1 BILAG B (moderate) activity score in any organ systems and a SELENA-SLEDAI score of ≥ 6.
✕. Approval, by an adjudication committee of a brief entry packet describing the type, severity and duration of symptoms meeting the minimal criteria for entry. The participant will meet this criterion if the committee is confident of all of the following:
✕. Convincing diagnosis of SLE,
✕. Active disease, due to SLE, warranting the potential of dual therapy with potent immune modulators,
✕. No medical or other condition to contraindicate participation in a placebo-controlled, outpatient study of this design.
What they're measuring
1
The Percentage of Participants Who Experience a Stage 2 Treatment Failure at or Before the Stage 2 Week 24 Visit.
Timeframe: From Baseline to Stage 2 Week 24
Trial details
NCT IDNCT05306873
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Women of childbearing potential must have a negative serum pregnancy test at screening.
✕. Able or willing to use reliable methods of contraception, as outlined in the Mycophenolate REMS brochure for health care providers, from 4 weeks prior to first randomization to 6 weeks after completion of the study. This criterion applies to females of reproductive potential.