Phase 4 N=172 Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
Lupus Erythematosus, Systemic
Primary: Physician's Global Assessment (PGA) — 58.8; 60.6; 33.2; 30.2 score on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=102 A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Primary: Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24 — 33.3; 61.7 Percentage of participants…
Phase 4 N=38 Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease
Systemic Lupus Erythematosus (SLE)
Primary: Number of Participants Who Meet the Definition of a Responder Within 4 Weeks — 3; 4 Participants
Phase 2 N=25 A Study of DS-7011a in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Primary: Number of Participants With Treatment-emergent Adverse Events Following Administration With DS-7011a in Participants With Systemic Lupus Erythematosus — 11; 4 Participants
Phase 2 N=76 ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 23; 24; 2; 2 Participants
Phase 2 N=183 Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
Systemic Lupus Erythematosus
Primary: Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare — 94; 47 Participants
Phase 2 N=307 A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Primary: Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169 — 17.6…
Phase 2 N=346 Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
Lupus
Primary: Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 — 59.4; 63.2; 57.4; 58.6 Percentage of participants — p=0.9745
Phase 2 N=67 Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Primary: Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) — -0.26; -0.96; -0.86; -0.87 10^9 cells/L — p=0.39
Phase 3 N=1,164 A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus · Connective Tissue Disease · Autoimmune Disease
Primary: Percentage of Participants Achieving an SLE Responder Index Response at Week 52 — 31.8; 35.2; 29.3 percentage of participants
Phase 2 N=99 Prospective Study of Rapamycin for the Treatment of SLE
Systemic Lupus Erythematosus (SLE)
Primary: Reduction of the Disease Activity as Measured by SLEDAI and BILAG Scores. — 10.2; 28.4 score on a scale
Phase 3 N=1,124 A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus · Connective Tissue Disease · Autoimmune Disease
Primary: Percentage of Participants Achieving an SLE Responder Index Response at Week 52 — 38.5; 34.8; 27.7 percentage of participants
Phase 3 N=461 Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
Lupus Erythematosus, Systemic
Primary: Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B — 57.32; 36.11; 53.25 percentage of…
Phase 2 N=185 A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State
Systemic Lupus Erythematosus (SLE)
Primary: Number of Participants With Treatment-Emergent Adverse Events — 34; 31; 30; 11 participants
N/A N=58 Exercise and Arterial Stiffness in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Primary: Arterial Stiffness — -0.26; -0.22 m/s
Phase 2 N=158 Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus
Primary: Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline — 45; 71 days to flare — p=0.2738
Phase 2 N=432 A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Primary: Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) — 45.4; 58.3; 56.5; 59.8 percentage of participants — p=0.057
Phase 2 N=9 Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Primary: Relapse-free Complete Clinical Response — 54 Months
Phase 2 N=183 A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus
Primary: Number of Participants Achieving a Combined Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24 — 37; 31 Participants…
Phase 3 N=365 Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Active Systemic Lupus Erythematosus
Primary: Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 — 86; 57 Participants — p=0.0013
Phase 2 N=350 A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Systemic Lupus Erythematosus
Primary: Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52 — 64.6; 57.4; 69.7; 66.3 Percentage of participants — p=0.8076
Phase 4 N=4,019 Belimumab Assessment of Safety in SLE
Systemic Lupus Erythematosus
Primary: Number of Deaths - On Treatment Period (Week 52) — 8; 10 Participants
Phase 2 N=306 Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Primary: Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline — 57.8; 53.8; 44.0 percentage…
Phase 2 N=64 A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus
Primary: Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo. — -6.2; -6.5; -6.2; -5.7 Scores on a scale — p=0.845
Phase 2 N=427 Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Primary: Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score — -3.2; -3.41; -2.84; -4.04 score on a scale — p=0.4749
N/A N=699 Women Empowered to Live With Lupus Study
Lupus Erythematosus, Systemic
Primary: Communication With Physician - Stanford 3Q Scale Score — 3.1; 2.9; 3.3; 3.0 score on a scale
Phase 2 N=289 A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Primary: Number of Participants Who Achieve SLE Responder Index (SRI) (4) Response — 29; 20; 33; 44 Number of participants — p=0.214
Phase 2 N=66 Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches
Systemic Lupus Erythematosus
Primary: British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) — 8; 8 Participants — p=>0.999
Phase 2 N=312 A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Primary: Number and Percentage of Subjects Who Achieved a Response at Week 24 According to the Modified British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus…
Phase 2 N=264 Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus · Active Cutaneous Lupus Erythematosus
Primary: Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24 — -12.7; -9.0; -13.0; -14.5 joints — p=0.037