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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)
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 227833
Phoenix, Arizona, United States
Wallace Rheumatic Studies Center, LLC /ID# 224374
Beverly Hills, California, United States
Valerius Medical Group & Research Center /ID# 223922
Los Alamitos, California, United States
East Bay Rheumatology Medical /ID# 225493
San Leandro, California, United States
University of Colorado Hospital /ID# 245087
Aurora, Colorado, United States
Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 227828
Aventura, Florida, United States
Millennium Research /ID# 233192
Ormond Beach, Florida, United States
IRIS Research and Development, LLC /ID# 227814
Plantation, Florida, United States
Deerbrook Medical Associates /ID# 227330
Libertyville, Illinois, United States
Qualmedica Research, LLC /ID# 227817
Evansville, Indiana, United States
Start Date
July 27, 2020
Primary Completion Date
January 3, 2024
Completion Date
January 3, 2024
Last Updated
January 14, 2025
185
ACTUAL participants
Elsubrutinib
DRUG
Placebo for Elsubrutinib
DRUG
Upadacitinib
DRUG
Placebo for Upadacitinib
DRUG
Lead Sponsor
AbbVie
NCT06647069
NCT06875960
Data Source & Attribution
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