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Condition (MeSH)

Lupus Erythematosus, Systemic

ClinicalTrials.gov lists 1,390 trials for Lupus Erythematosus, Systemic or a narrower condition beneath it. AstraZeneca has the most among industry and government lead sponsors, with 35.

MeSH D008180 Skin and Connective Tissue Diseases C17 C20 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 285 Phase 1/2 Phase 1/2 76 Phase 2 Phase 2 229 Phase 2/3 Phase 2/3 24 Phase 3 Phase 3 132 Phase 4 Phase 4 79 Not applicable Not applicable 228 Observational Observational 333 Phase 1 Phase 1 285 Phase 1/2 Phase 1/2 76 Phase 2 Phase 2 229 Phase 2/3 Phase 2/3 24 Phase 3 Phase 3 132 Phase 4 Phase 4 79 Not applicable Not applicable 228 Observational Observational 333

Trials per phase

1 more section with rows

1,176 of the 1,390 trials are tagged with Lupus Erythematosus, Systemic itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Lupus Erythematosus, Systemic trials start? (35)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 3 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 143

1991: 2 trials (Observational 1, Phase 2 1) 1993: 1 trials (Observational 1) 1994: 4 trials (Observational 2, Not applicable 1, Phase 2/3 1) 1995: 5 trials (Observational 2, Phase 3 1, Phase 2 2) 1996: 5 trials (Observational 3, Phase 3 2) 1997: 6 trials (Not applicable 2, Phase 4 1, Phase 3 1, Phase 2 2) 1998: 2 trials (Phase 3 1, Phase 1 1) 1999: 2 trials (Observational 1, Phase 2 1) 2000: 6 trials (Observational 1, Not applicable 2, Phase 3 1, Phase 2 1, Phase 1 1) 2001: 6 trials (Observational 1, Phase 3 2, Phase 1/2 1, Phase 1 2) 2002: 14 trials (Observational 2, Not applicable 1, Phase 4 2, Phase 3 1, Phase 2/3 1, Phase 2 4, Phase 1 3) 2003: 18 trials (Observational 4, Not applicable 3, Phase 3 3, Phase 2/3 2, Phase 2 3, Phase 1/2 1, Phase 1 2) 2004: 12 trials (Observational 1, Not applicable 3, Phase 4 1, Phase 3 1, Phase 2 2, Phase 1/2 1, Phase 1 3) 2005: 18 trials (Observational 2, Not applicable 2, Phase 4 1, Phase 3 4, Phase 2/3 1, Phase 2 6, Phase 1 2) 2006: 21 trials (Observational 1, Not applicable 4, Phase 4 2, Phase 3 5, Phase 2/3 1, Phase 2 4, Phase 1/2 2, Phase 1 2) 2007: 37 trials (Observational 12, Not applicable 1, Phase 4 4, Phase 3 5, Phase 2/3 3, Phase 2 2, Phase 1/2 2, Phase 1 8) 2008: 27 trials (Observational 3, Not applicable 3, Phase 4 2, Phase 3 3, Phase 2/3 2, Phase 2 10, Phase 1/2 1, Phase 1 3) 2009: 29 trials (Observational 4, Not applicable 6, Phase 4 4, Phase 3 1, Phase 2/3 1, Phase 2 5, Phase 1/2 1, Phase 1 7) 2010: 39 trials (Observational 8, Not applicable 9, Phase 4 4, Phase 3 5, Phase 2 7, Phase 1/2 2, Phase 1 4) 2011: 33 trials (Observational 4, Not applicable 3, Phase 4 3, Phase 3 9, Phase 2/3 1, Phase 2 7, Phase 1/2 1, Phase 1 5) 2012: 35 trials (Observational 9, Not applicable 4, Phase 4 2, Phase 3 4, Phase 2/3 1, Phase 2 10, Phase 1/2 2, Phase 1 3) 2013: 38 trials (Observational 14, Not applicable 7, Phase 4 3, Phase 3 2, Phase 2 7, Phase 1/2 1, Phase 1 4) 2014: 39 trials (Observational 8, Not applicable 6, Phase 4 2, Phase 3 5, Phase 2 10, Phase 1 8) 2015: 40 trials (Observational 8, Phase 4 2, Phase 3 6, Phase 2 14, Phase 1/2 3, Phase 1 7) 2016: 31 trials (Observational 4, Not applicable 8, Phase 4 3, Phase 3 1, Phase 2 8, Phase 1/2 1, Phase 1 6) 2017: 54 trials (Observational 14, Not applicable 15, Phase 4 3, Phase 3 1, Phase 2 9, Phase 1/2 1, Phase 1 11) 2018: 59 trials (Observational 16, Not applicable 14, Phase 4 1, Phase 3 6, Phase 2 12, Phase 1/2 2, Phase 1 8) 2019: 49 trials (Observational 14, Not applicable 10, Phase 4 3, Phase 3 3, Phase 2/3 1, Phase 2 10, Phase 1/2 1, Phase 1 7) 2020: 53 trials (Observational 25, Not applicable 11, Phase 4 3, Phase 3 4, Phase 2 7, Phase 1/2 1, Phase 1 2) 2021: 82 trials (Observational 28, Not applicable 14, Phase 4 6, Phase 3 10, Phase 2/3 2, Phase 2 12, Phase 1/2 1, Phase 1 9) 2022: 92 trials (Observational 18, Not applicable 26, Phase 4 6, Phase 3 11, Phase 2/3 4, Phase 2 13, Phase 1/2 4, Phase 1 10) 2023: 95 trials (Observational 29, Not applicable 10, Phase 4 5, Phase 3 11, Phase 2/3 1, Phase 2 17, Phase 1/2 7, Phase 1 15) 2024: 133 trials (Observational 30, Not applicable 25, Phase 4 5, Phase 3 7, Phase 2 9, Phase 1/2 16, Phase 1 41) 2025: 143 trials (Observational 32, Not applicable 17, Phase 4 2, Phase 3 3, Phase 2 13, Phase 1/2 12, Phase 1 64)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 148
2025 143
2024 133
2023 95
2022 92
2021 82
2020 53
2019 49
2018 59
2017 54

Showing 10 of 35 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 170 trials starting in 2026 and about 150 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 13 percent and ran about 12 percent low against the count later registered; forecasts made before the year began were off by about 19 percent and ran about 17 percent low against the count later registered, and had about the same error as repeating last year's count. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 225 trials still running at the 2026-10-09 snapshot; registered median of 27 months across 643 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Lupus Erythematosus, Systemic trials in? (9)

Shown in this order: phase order.

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Trials by phase
Phase Trials
Phase 1 285
Phase 1/2 76
Phase 2 229
Phase 2/3 24
Phase 3 132
Phase 4 79
Not applicable 228
Observational 333
Expanded access 4

How many Lupus Erythematosus, Systemic trials are recruiting? (11)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 107
Recruiting 278
Enrolling by invitation 14
Active, not recruiting 73
Available 1

Showing 5 of 11 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Lupus Erythematosus, Systemic trials? (8)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
AstraZeneca 35
GlaxoSmithKline 31
Amgen 20
Novartis Pharmaceuticals 18
Bristol-Myers Squibb 17

Showing 5 of 8 sponsors.

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Which drugs are being tested for Lupus Erythematosus, Systemic? (8)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Cytoxan 55
Belimumab 39
RITUXIMAB 26
Prednisone 23
METHYLPREDNISOLONE 18

Showing 5 of 8 drugs.

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Interventions as named in the registry (7)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
Mofetil Mycophenolate 39
Anifrolumab SC infusion (600mg) 22
SQ Fludarabine 21
IR Tacrolimus 17
Azathioprine Pill 16

Showing 5 of 7 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Lupus Erythematosus, Systemic trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Pneumonia 581 85
Systemic lupus erythematosus 407 65
Lupus nephritis 243 48
Any event 231 2
Cellulitis 230 62

Showing 5 of 10 adverse events.

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Which publications cover Lupus Erythematosus, Systemic? (1,353)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Efficacy and safety of allogeneic CD19 CAR NK-cell therapy in systemic lupus erythematosus: a case series in China. Lancet (London, England) 2026 Yes
Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford, England) 2025 Yes
Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial. The Lancet. Rheumatology 2025 Yes
Clinical outcomes of baricitinib in patients with systemic lupus erythematosus: Pooled analysis of SLE-BRAVE-I and SLE-BRAVE-II trials. PloS one 2025 Yes
Population pharmacokinetic modelling of prednisolone in systemic lupus erythematosus patients: Analysis of exposure and disease activity. British journal of clinical pharmacology 2025 Yes

Showing 5 of 1,353 publications.

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Prevalence (33)

Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.

Prevalence
Orphanet disease Type Class Geography Jurisdiction Mapping relation
Systemic lupus erythematosus Point prevalence 1-5 / 10 000 United States US Exact
Systemic lupus erythematosus Point prevalence 1-5 / 10 000 United States US Unspecified
Systemic lupus erythematosus Point prevalence 1-5 / 10 000 United States US Exact
Systemic lupus erythematosus Annual incidence 1-9 / 100 000 Worldwide Not stated Unspecified
Systemic lupus erythematosus Point prevalence 1-5 / 10 000 Europe Not stated Unspecified

Showing 5 of 33 prevalence observations.

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Rare-disease identity (2)

Shown in this order: exact, broader, narrower, other.

Rare-disease identity
Orphanet disease ORPHA code Relation Source
Systemic lupus erythematosus 536 Exact Orphanet Rare Disease Ontology (ORDO)
Systemic lupus erythematosus 536 Exact Orphadata Science knowledge files, Product 1

Sub-conditions in MeSH (2)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

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