Name (Synonyms) | Correlation | |
---|---|---|
D008180 | Lupus Erythematosus, Systemic NIH | 0.41 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002725 | Systemic lupus erythematosus HPO | 0.41 |
There is one clinical trial.
The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving stable background therapy for SLE.
Description: The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 definitions of Grade 1 through Grade 5. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measure: Number of Participants With Grade 3 or Higher TEAEs Time: Up to Week 36Description: Immune cell subsets will include plasma cells, plasma blast (PBs), natural killer (NK) cells, B cells, T cells, monocytes, and total lymphocytes.
Measure: Number of Participants With Change From Baseline In Immune Cell Subsets Time: Baseline up to Day 85Description: CD38 expression and receptor occupancy will be evaluated for plasma cells, PBs, NK cells, B cells, T cells, and monocytes.
Measure: Number of Participants With Change From Baseline in (Cluster of Differentiation 38) CD38 Expression Level and Receptor Occupancy Time: Baseline up to Day 85Description: Cytokine measurements will be assessed from baseline at different timepoints for placebo and each TAK-079 dose level.
Measure: Change From Baseline in Cytokines Level Time: Baseline up to Day 85