NCT04451772

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide. Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study. Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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: 2020-07-27
• Primary completion: 2024-01-03
• Completion: 2024-01-03
• First posted: 2020-06-30
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

87 sites across 18 countries: United States, Argentina, Australia, Bulgaria, China, Colombia, Germany, Hungary, Italy, Japan, Mexico, New Zealand, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study