NCT04451772
Brief 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.
Interventional study
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Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
From 18 Years to 65 Years.
Inclusion Criteria:
- Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib,
upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matching
placebo) and will not have developed any laboratory or clinical discontinuation
criteria as defined in that study.
- On stable background treatment for SLE throughout the study.
Exclusion Criteria:
- Active, chronic, or recurrent viral, or bacterial infection.
- Active tuberculosis (TB)
- History of gastrointestinal (GI) perforation, diverticulitis, or a significantly
increased risk for GI perforation per investigator assessment.
- Participant require vaccination with live vaccine during study participation.