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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: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment failure is defined as the first occurrence after randomization (Stage 2) of any of the following events: 1. Methylprednisolone acetate injection or treatment with a new or increased lupus medication, except the occasional use of corticosteroids for reasons not associated with Systemic Lupus Erythematosus (SLE) flare 2. British Isles Lupus Assessment Group (BILAG) flare, defined as any item marked new or worse that could support a BILAG A (severe flare) or 2 organs with items marked ne
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Voclosporin
- DRUG Placebo for Mycophenolate Mofetil
- DRUG Placebo for Voclosporin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2024-07-11 |
| Phase | Phase 2 |
Why NCT05306873 stopped before completion
NCT05306873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 4 interventions - of which Mycophenolate Mofetil is the first listed.
NCT05306873 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05306873's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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