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)

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

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (superiority test); Elsubrutinib Placebo/Upadacitinib Placebo vs ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg); p =0.081; Response Rate Difference 12.8 (95% CI -1.6 to 27.1); Cochran-Mantel-Haenszel reads as mixed primary results NCT03978520 ↗

registry analysis (superiority test); Elsubrutinib Placebo/Upadacitinib Placebo vs Elsubrutinib Placebo/Upadacitinib 30 mg; p =0.028; Response Rate Difference 16.9 (95% CI 1.8 to 31.9); Cochran-Mantel-Haenszel reads as mixed primary results NCT03978520 ↗

release “The SLEek study met the primary endpoint of SLE Responder Index (SRI-4)” reads as met primary endpoint abbvie.com ↗

Publications

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elsubrutinib	Small molecule	60 mg	Oral
Subject	Upadacitinib	Small molecule	15 mg	Oral
Subject	Upadacitinib	Small molecule	30 mg	Oral

Indications