drugset
drugset / Trial / NCT03724916

A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)

NCT03724916 ↗

Phase 1 Completed 23 enrolled Millennium Pharmaceuticals, Inc.
RandomizedSequentialQuadruple-blindOther

Summary

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.

Timeline

Start
2018-11-26
Primary completion
2021-11-04
Completion
2021-11-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Mezagitamab Monoclonal antibody 45 mg Subcutaneous
Subject Mezagitamab Monoclonal antibody 90 mg Subcutaneous
Subject Mezagitamab Monoclonal antibody 135 mg Subcutaneous

Indications

systemic lupus erythematosus