Clinical Trial Search

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

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

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

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

Primary: Number of Participants Achieving a Combined Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24 — 37; 31 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: Percentage of Participants Achieving an SLE Responder Index Response at Week 52 — 38.5; 34.8; 27.7 percentage of participants

Primary: Change in Vascular Function and Cardiometabolic Risk as Measured by Left CAVI at Month 3 — -0.32; 0.09 unitless

Primary: Relapse-free Complete Clinical Response — 54 Months

Primary: Number of Deaths - On Treatment Period (Week 52) — 8; 10 Participants

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

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 Experienced a Treatment-emergent Adverse Event (TEAE) — 7; 5; 5; 7 Participants

Primary: British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) — 8; 8 Participants — p=>0.999

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…

Primary: Arterial Stiffness — -0.26; -0.22 m/s

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

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

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: Number of Participants With Treatment-Emergent Adverse Events — 34; 31; 30; 11 participants

Primary: SLE Responder Index (SRI) Response Rate at Week 52 — 43.6; 51.4; 57.6 Percentage of participants — p=0.0006

Primary: Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy — 48; 29; 44; 24 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: Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24 — 20; 27; 22; 22…

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

Primary: Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence — 116 Participants

Primary: Number of Participants Who Meet the Definition of a Responder Within 4 Weeks — 3; 4 Participants