CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 341 enrolled
Drug / intervention
Elsubrutinib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03978520
NCT03978520Phase 2Completed
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A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

AbbVie·interventional·Posted Jun 7, 2019·Updated Jul 21, 2023

In Brief

A Phase 2 clinical trial evaluating Elsubrutinib, Placebo for elsubrutinib, and 2 other interventions for Systemic Lupus Erythematosus (SLE). Completed, enrolled 341 participants across 160 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus (SLE)
CountriesArgentina, Australia, Bulgaria, Canada, China, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 7, 2019
Enrollment StartJul 25, 2019
Primary CompletionJan 19, 2022
Study CompletionJul 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.1 years ago

Interventions

Elsubrutinibdrug

Capsule; Oral

Placebo for elsubrutinibdrug

Capsule; Oral

Upadacitinibdrug

Film-coated tablet; Oral

Placebo for upadacitinibdrug

Film-coated tablet; Oral