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NCT05306873 · ClinicalTrials.gov registry record · Phase 2

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Terminated
Registry status
Phase 2
Development phase
12
Enrollment target

NCT05306873 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 12 participants.

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The verdict

NCT05306873, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

TERMINATED
Registry status
Phase 2
Development phase
12 participants
Enrollment target

Study 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.

Interventions

  • DRUG Mycophenolate Mofetil
  • DRUG Voclosporin
  • DRUG Placebo for Mycophenolate Mofetil
  • DRUG Placebo for Voclosporin

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2022-11-30
Est. Completion 2024-07-11
Phase Phase 2

What the Registry Record Tells You About NCT05306873

The ClinicalTrials.gov registry entry for NCT05306873 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Mycophenolate Mofetil is the first listed.

NCT05306873 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05306873 about?

NCT05306873 is a clinical study titled "Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus". 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 ...

What is the current status of trial NCT05306873?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2022-11-30. Estimated completion is 2024-07-11.

What interventions are being tested in trial NCT05306873?

The interventions under investigation include: Mycophenolate Mofetil (DRUG), Voclosporin (DRUG), Placebo for Mycophenolate Mofetil (DRUG), Placebo for Voclosporin (DRUG).

Who is sponsoring clinical trial NCT05306873?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.