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: 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 Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169 — 17.6…

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

Primary: Relapse-free Complete Clinical Response — 54 Months

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

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

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

Primary: Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates) — 20; 20; 20; 20 Participants

Primary: Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 — 48.4; 61.4 Percentage of par. — p=0.0006

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

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: Percent of Participants With an IFN Alpha Signature Response at Week 12 — 36.8; 23.5; 27.8; 25.7 Percent of participants — p=0.53

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

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

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

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

Primary: Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus…

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

Primary: Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) — 26; 45; 25; 51 Participants

Primary: SLE Responder Index (SRI) Response Rate at Week 52 — 33.5; 40.6; 43.2 Percentage of participants — p=0.0167

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

Primary: Number of Participants Who Were SLE Responders (SRI) — 12; 27; 33; 34 participants

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