Clinical Trial Search

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…

Primary: Number of Participants With Treatment-emergent Adverse Events Following Administration With DS-7011a in Participants With Systemic Lupus Erythematosus — 11; 4 Participants

Primary: Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture — 52; 94; 19; 90 percentage of participants

Primary: Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. — 22.2; 27.8 percentage of subjects

Primary: Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile — 89.22; 91.41; 145.68; 146.72 msec

Primary: Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score — -1 Units on a scale

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

Primary: Number of Participants With Emergent Chemistry Results by Potential Clinical Importance (PCI) Criteria — 0; 11; 0; 10 Participants

Primary: The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index — 34.1; 39.8; 37.5 percentage of participants — p==0.175

Primary: Relapse-free Complete Clinical Response — 54 Months

Primary: Communication With Physician - Stanford 3Q Scale Score — 3.1; 2.9; 3.3; 3.0 score on a scale

Primary: Cutaneous Lupus Area and Severity Index (CLASI) — 21.4; 10.8; 8.6; 5.3 units on a scale

Primary: Reduction of the Disease Activity as Measured by SLEDAI and BILAG Scores. — 10.2; 28.4 score on a scale

Primary: Number of Treatment Emergent Adverse Events — 0; 17; 2; 4 Participants

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

Primary: Change in Percentage of UVB-induced Apoptotic Epidermal Cells — 20.06; 3.03; -17.03 percentage of epidermal cells

Primary: The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index — 33.5; 34.1; 35.2 Percentage of responders — p==0.899

Primary: Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24 — 59.9; 39.2; 40.1 Percentage of participants — p=0.076

Primary: Percentage of Participants Achieving an SLE Responder Index Response at Week 52 — 31.8; 35.2; 29.3 percentage of participants

Primary: Mean Severity of Disease as Measured by the Investigator's Global Assessment — 1.4 score on a scale

Primary: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) — 7; 5; 5; 7 Participants

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…

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

Primary: Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12 — -37.05; -42.76 percent change

Primary: Percentage of Participants Achieving an SLE Responder Index Response at Week 52 — 38.5; 34.8; 27.7 percentage of participants

Primary: Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare — 94; 47 Participants

Primary: Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. — 0.32; 0.33; 0.32; 0.33 cm — p=0.87

Primary: Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline — 45; 71 days to flare — p=0.2738

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

Primary: Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32 — 31; 53; 46; 40 Participants — p=0.0006