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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
DRUG	Elsubrutinib	Capsule; Oral
DRUG	Placebo for elsubrutinib	Capsule; Oral
DRUG	Upadacitinib	Film-coated tablet; Oral
DRUG	Placebo for upadacitinib	Film-coated tablet; Oral

Timeline

• Start date: 2019-07-25
• Primary completion: 2022-01-19
• Completion: 2022-07-14
• First posted: 2019-06-07
• Last updated: 2023-07-21
• Results posted: 2023-07-21

Locations

160 sites across 21 countries: United States, Argentina, Australia, Bulgaria, Canada, China, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study