Trial · NCT05306873
Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus
NCT05306873, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2025-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus. Trials, record NCT05306873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05306873
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus
- NCT number
- NCT05306873
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Mycophenolate Mofetil, Placebo for Mycophenolate Mofetil, Voclosporin, Placebo for Voclosporin, Mycophenolate Mofetil
- First posted
- 2022-04-01
- Last updated
- 2025-09-09
- Results first posted
- 2025-09-09
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants Who Experience a Stage 2 Treatment Failure at or Before the Stage 2 Week 24 Visit. | From Baseline to Stage 2 Week 24 | 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 new or worse that could support a BILAG B (moderate flare), and if the participant's condition is deemed by the investigator to be "moderately worse" or "much worse" compared to the day of randomization, as assessed by the Clinician Global Impression of Change (CGI-C) 3. Premature permanent discontinuation of study-assigned treatment for any reason |
| Secondary | Clinical Response in Stage 2, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 2 Week 24. | Stage 2 Week 24 | The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as meeting all of the following criteria: * Improvement of all Screening BILAG A scores to B, C or D * Improvement of all Screening BILAG B scores to C or D * No new BILAG A score among organs scored as B, C, D, or E at Screening * \<= 1 new BILAG B score among organs scored as C, D, or E at Screening * No worsening of the Hybrid Systemic Lupus Erythematosus Disease Activity Index (H-SLEDAI) * Less than a 10% increase (worsening) in the Physician's Global Assessment (PGA) Participants who experience treatment failure prior to Stage 2 Week 24 visit are imputed as BICLA Non-responders at Stage 2 Week 24. Participants who do not have evaluable data at Stage 2 Week 24 for reasons other than a treatment failure are not imputed. |
| Secondary | The Proportion of Participants Who Experience a Stage 3 Treatment Failure, After Stage 3 Re-randomization at or Before Completing Stage 3 Week 24. | From re-randomization to Stage 3 Week 24 | Treatment failure is defined as the first occurrence after re-randomization (Stage 3) 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 new or worse that could support a BILAG B (moderate flare), and if the participant's condition is deemed by the investigator to be "moderately worse" or "much worse" compared to the day of randomization, as assessed by the Clinician Global Impression of Change (CGI-C) 3. Premature permanent discontinuation of study-assigned treatment for any reason |
| Secondary | Time to Treatment Failure in Stage 3, Defined as the Interval From the Day of Stage 3 Randomization Until the Day of Treatment Failure. | Start of Stage 3 up to the day of treatment failure | Treatment failure is defined as the first occurrence after re-randomization (Stage 3) 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 new or worse that could support a BILAG B (moderate flare), and if the participant's condition is deemed by the investigator to be "moderately worse" or "much worse" compared to the day of randomization, as assessed by the Clinician Global Impression of Change (CGI-C) 3. Premature permanent discontinuation of study-assigned treatment for any reason |
| Secondary | Clinical Response in Stage 3, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 3 Week 24. | Stage 3 Week 24 | The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as meeting all of the following criteria: * Improvement of all Screening BILAG A scores to B, C or D * Improvement of all Screening BILAG B scores to C or D * No new BILAG A score among organs scored as B, C, D, or E at Screening * \<= 1 new BILAG B score among organs scored as C, D, or E at Screening * No worsening of the Hybrid Systemic Lupus Erythematosus Disease Activity Index (H-SLEDAI) * Less than a 10% increase (worsening) in the Physician's Global Assessment (PGA) Participants who experience treatment failure prior to Stage 3 Week 24 visit are imputed as BICLA Non-responders at Stage 2 Week 24. Participants who do not have evaluable data at Stage 3 Week 24 for reasons other than a treatment failure are not imputed. |
| Secondary | The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 2 | Stage 2 Day 0 up to Stage 2 Week 48 | Defined as adverse events that emerged during Stage 2 that are of Grade 3 or higher with a relationship to Stage 2 study drug of Possible or Definite. |
| Secondary | The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 3 | After Stage 3 re-randomization Day 0 to Stage 3 Week 24 | Defined as adverse events that emerged during Stage 3 that are of Grade 3 or higher with a relationship to Stage 3 study drug of Possible or Definite. |
| Secondary | The Incidence of Grade 3 or Higher Infections in Stage 1 | Day -28 to Day -1 | Defined as infection adverse events that emerged during Stage 1 and are of Grade 3 or higher. |
| Secondary | The Incidence of Grade 3 or Higher Infections in Stage 2 | Stage 2 Day 0 up to Stage 2 Week 48 | Defined as infection adverse events that emerged during Stage 2 and are of Grade 3 or higher. |
| Secondary | The Incidence of Grade 3 or Higher Infections in Stage 3 | After Stage 3 re-randomization Day 0 to Stage 3 Week 24 | Defined as infection adverse events that emerged during Stage 3 and are of Grade 3 or higher. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Participants Who Experience a Stage 2 Treatment Failure at or Before the Stage 2 Week 24 Visit. | From Baseline to Stage 2 Week 24 | The modified Intent-to-Treat population includes all Stage 2 randomized participants who received at least one dose of Stage 2 study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Response in Stage 2, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 2 Week 24. | Stage 2 Week 24 | Includes all Stage 2 randomized participants who received at least one dose of Stage 2 study drug and had evaluable data at the Stage 2 Week 24 visit. Participants who experience treatment failure prior to Stage 2 Week 24 visit are considered BICLA Non-responders at Stage 2 Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Proportion of Participants Who Experience a Stage 3 Treatment Failure, After Stage 3 Re-randomization at or Before Completing Stage 3 Week 24. | From re-randomization to Stage 3 Week 24 | The Stage 3 modified Intent-to-Treat population consists of all Stage 3 re-randomized participants who received at least one dose of Stage 3 study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Treatment Failure in Stage 3, Defined as the Interval From the Day of Stage 3 Randomization Until the Day of Treatment Failure. | Start of Stage 3 up to the day of treatment failure | All Stage 3 re-randomized participants who received at least one dose of Stage 3 study drug and experienced a Stage 3 treatment failure. | Days | MEAN |
| SECONDARY | Clinical Response in Stage 3, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 3 Week 24. | Stage 3 Week 24 | Includes all Stage 3 re-randomized participants who received at least one dose Stage 3 study drug and had evaluable data at the Stage 3 Week 24 visit. Participants who experience treatment failure prior to Stage 3 Week 24 visit are considered BICLA Non-responders at Stage 3 Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 2 | Stage 2 Day 0 up to Stage 2 Week 48 | Includes all participants who received at least one dose of Stage 2 study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 3 | After Stage 3 re-randomization Day 0 to Stage 3 Week 24 | Includes all participants who received at least one dose of Stage 3 study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Incidence of Grade 3 or Higher Infections in Stage 1 | Day -28 to Day -1 | Includes all participants who receive at least one IM injection of a long-acting corticosteroid or who initiate withdrawal of lupus medications in Stage 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Incidence of Grade 3 or Higher Infections in Stage 2 | Stage 2 Day 0 up to Stage 2 Week 48 | Includes participants who received at least one dose of Stage 2 study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Incidence of Grade 3 or Higher Infections in Stage 3 | After Stage 3 re-randomization Day 0 to Stage 3 Week 24 | Includes participants who received at least one dose of Stage 3 study drug. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Participants Who Experience a Stage 2 Treatment Failure at or Before the Stage 2 Week 24 Visit. | Stage 2 MMF | 2 | Participants | ||
| The Percentage of Participants Who Experience a Stage 2 Treatment Failure at or Before the Stage 2 Week 24 Visit. | Stage 2 Placebo for MMF | 2 | Participants | ||
| Clinical Response in Stage 2, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 2 Week 24. | Stage 2 MMF | BICLA Responder | 1 | Participants | |
| Clinical Response in Stage 2, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 2 Week 24. | Stage 2 Placebo for MMF | BICLA Responder | 0 | Participants | |
| Clinical Response in Stage 2, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 2 Week 24. | Stage 2 MMF | BICLA Non-responder | 2 | Participants | |
| Clinical Response in Stage 2, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 2 Week 24. | Stage 2 Placebo for MMF | BICLA Non-responder | 3 | Participants | |
| The Proportion of Participants Who Experience a Stage 3 Treatment Failure, After Stage 3 Re-randomization at or Before Completing Stage 3 Week 24. | Stage 3 MMF + Voclosporin | 0 | Participants | ||
| The Proportion of Participants Who Experience a Stage 3 Treatment Failure, After Stage 3 Re-randomization at or Before Completing Stage 3 Week 24. | Stage 3 MMF + Placebo for Voclosporin | 1 | Participants | ||
| Time to Treatment Failure in Stage 3, Defined as the Interval From the Day of Stage 3 Randomization Until the Day of Treatment Failure. | Stage 3 MMF + Placebo for Voclosporin | 69 | Standard Deviation NA | Days | |
| Clinical Response in Stage 3, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 3 Week 24. | Stage 3 MMF + Voclosporin | BICLA Responder | 0 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage 2 | STARTED | Stage 2 MMF | 4 | |
| Stage 2 | STARTED | Stage 2 Placebo for MMF | 4 | |
| Stage 2 | STARTED | Stage 3 MMF + Voclosporin | 0 | |
| Stage 2 | STARTED | Stage 3 MMF + Placebo for Voclosporin | 0 | |
| Stage 2 | COMPLETED | Stage 2 MMF | 0 | |
| Stage 2 | COMPLETED | Stage 2 Placebo for MMF | 0 | |
| Stage 2 | COMPLETED | Stage 3 MMF + Voclosporin | 0 | |
| Stage 2 | COMPLETED | Stage 3 MMF + Placebo for Voclosporin | 0 | |
| Stage 2 | NOT COMPLETED | Stage 2 MMF | 4 | |
| Stage 2 | NOT COMPLETED | Stage 2 Placebo for MMF | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events95
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Stage 1 Corticosteroid During Treatment Withdrawal | 0 | 12 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Stage 2 MMF | 1 | 4 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Stage 2 Placebo | 0 | 4 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Stage 3 MMF + Voclosporin | 0 | 2 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Stage 3 MMF + Placebo | 0 | 1 | 0 |
| other | Pericarditis | Cardiac disorders | Stage 1 Corticosteroid During Treatment Withdrawal | 1 | 12 | 1 |
| other | Pericarditis | Cardiac disorders | Stage 2 MMF | 0 | 4 | 0 |
| other | Pericarditis | Cardiac disorders | Stage 2 Placebo | 0 | 4 | 0 |
| other | Pericarditis | Cardiac disorders | Stage 3 MMF + Voclosporin | 0 | 2 | 0 |
| other | Pericarditis | Cardiac disorders | Stage 3 MMF + Placebo | 0 | 1 | 0 |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1 Corticosteroid During Treatment Withdrawal | 0 | 12 |
| Total, all-cause mortality | Stage 2 MMF | 0 | 4 |
| Total, all-cause mortality | Stage 2 Placebo | 0 | 4 |
| Total, all-cause mortality | Stage 3 MMF + Voclosporin | 0 | 2 |
| Total, all-cause mortality | Stage 3 MMF + Placebo | 0 | 1 |
| Total, other adverse events | Stage 1 Corticosteroid During Treatment Withdrawal | 2 | 12 |
| Total, other adverse events | Stage 2 MMF | 3 | 4 |
| Total, other adverse events | Stage 2 Placebo | 3 | 4 |
| Total, other adverse events | Stage 3 MMF + Voclosporin | 1 | 2 |
| Total, other adverse events | Stage 3 MMF + Placebo | 0 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Stage 2 MMF vs Stage 2 Placebo for MMF: The Percentage of Participants Who Experience a Stage 2 Treatment Failure at or Before the Stage 2 Week 24 Visit. | Trial comparisons |
| Stage 3 MMF + Voclosporin vs Stage 3 MMF + Placebo for Voclosporin: The Incidence of Grade 3 or Higher Hypertension in Stage 3 | Trial comparisons |
| Stage 3 MMF + Voclosporin vs Stage 3 MMF + Placebo for Voclosporin: The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 3 | Trial comparisons |
| Stage 3 MMF + Voclosporin vs Stage 3 MMF + Placebo for Voclosporin: The Incidence of Renal Dysfunction in Stage 3 | Trial comparisons |
Stage 3 MMF + Voclosporin vs Stage 3 MMF + Placebo for Voclosporin: The Proportion of Participants Who Experience a Stage 3 Treatment Failure, After Stage 3 Re-randomization at or Before Completing Stage 3 Week 24. | Trial comparisons |
| Stage 2 MMF vs Stage 2 Placebo for MMF: The Incidence of Grade 3 or Higher Infections in Stage 2 | Trial comparisons |
| Stage 2 MMF vs Stage 2 Placebo for MMF: The Incidence of Grade 3 or Higher Hypertension in Stage 2 | Trial comparisons |
| Stage 2 MMF vs Stage 2 Placebo for MMF: The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 2 | Trial comparisons |
| Stage 3 MMF + Voclosporin vs Stage 3 MMF + Placebo for Voclosporin: The Incidence of Grade 3 or Higher Infections in Stage 3 | Trial comparisons |
| Stage 2 MMF vs Stage 2 Placebo for MMF: The Incidence of Renal Dysfunction in Stage 2 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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