At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore the Safety, Pharmacokinetics, and Proof of Biological Activity of DS-7011a in Patients With Systemic Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating DS-7011a and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 26 participants across 20 sites in 4 countries.
Detailed Summary
Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized by autoantibody production, inflammation, and tissue damage in multiple organs. Standard of care therapies used to treat SLE are only partially effective and have a wide range of toxicities. There is a need for more effective and safer therapies for patients with SLE.
Study Details
Timeline
Interventions
20 mg/kg intravenous dose to be administered every 4 weeks at baseline (Day 1), Day 29, and Day 57
Saline intravenous solution administered every 4 weeks at baseline (Day 1), Day 29, and Day 57