drugset / Trial / NCT03978520

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

NCT03978520

Phase 2 Completed 341 enrolled AbbVie
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

Timeline

Start
2019-07-25
Primary completion
2022-01-19
Completion
2022-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Elsubrutinib Small molecule 60 mg Oral
Subject Upadacitinib Small molecule 15 mg Oral
Subject Upadacitinib Small molecule 30 mg Oral