Covid 19 Clinical Trials

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.

NCT03724916 Systemic Lupus Erythematosus Lupus Erythematosus, Systemic Drug: TAK-079 Drug: TAK-079 Placebo

MeSH:Lupus Erythematosus, Systemic

HPO:Systemic lupus erythematosus

Primary Outcomes

Measure: Number of Participants who Experience at Least one Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

Time: Up to Week 36

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 36

Measure: Percentage of Participants With Greater Than or Equal to (>=) 1 Adverse Event (AE) Leading to Treatment Discontinuation

Time: Up to Week 36

Secondary Outcomes

Measure: Cmax: Maximum Observed Plasma Concentration for TAK-079

Time: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose

Measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079

Description: 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 85

Description: 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 85

Description: 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

Measure: Number of Participants With Positive Anti-drug Antibodies

Time: Baseline up to Day 85

Related HPO nodes (Using clinical trials)

Protein Mutations 1

V600E

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (1)

Correlated MeSH Terms (1)

Correlated HPO Terms (1)

Clinical Trials

1 A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus

NCT03724916 Systemic Lupus Erythematosus Lupus Erythematosus, Systemic Drug: TAK-079 Drug: TAK-079 Placebo

MeSH:Lupus Erythematosus, Systemic

HPO:Systemic lupus erythematosus

Primary Outcomes

Secondary Outcomes

Related HPO nodes (Using clinical trials)

HP:0002725: Systemic lupus erythematosus

Genes 31

Protein Mutations 1

SNP 0