Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

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.
Secondary	The Incidence of Renal Dysfunction in Stage 1	Day -28 to Day -1	Defined as Grade 3 or higher chronic kidney disease with eGFR \< 30 ml/min per 1.73 m\^2
Secondary	The Incidence of Renal Dysfunction in Stage 2	Stage 2 Day 0 up to Stage 2 Week 48	Defined as Grade 3 or higher chronic kidney disease with eGFR \< 30 ml/min per 1.73 m\^2
Secondary	The Incidence of Renal Dysfunction in Stage 3	After Stage 3 re-randomization Day 0 to Stage 3 Week 24	Defined as Grade 3 or higher chronic kidney disease with eGFR \< 30 ml/min per 1.73 m\^2
Secondary	The Incidence of Grade 3 or Higher Hypertension in Stage 1	Day -28 to Day -1	Defined as a systolic blood pressure \>= 160 mm Hg or a diastolic blood pressure of \>= 100 mm Hg
Secondary	The Incidence of Grade 3 or Higher Hypertension in Stage 2	Stage 2 Day 0 up to Stage 2 Week 48	Defined as a systolic blood pressure \>= 160 mm Hg or a diastolic blood pressure of \>= 100 mm Hg
Secondary	The Incidence of Grade 3 or Higher Hypertension in Stage 3	After Stage 3 re-randomization Day 0 to Stage 3 Week 24	Defined as a systolic blood pressure \>= 160 mm Hg or a diastolic blood pressure of \>= 100 mm Hg

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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