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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
185
Capsule; Oral
Capsule; Oral
Film-coated tablet; Oral
Film-coated tablet; Oral
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
Number of Participants With Treatment-Emergent Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an adverse event with an onset date that is on or after the first dose of study drug from Study M20-186, and no more than 30 days after the last dose of study drug from Study M20-186. For more details on adverse events please see the Adverse Event section.
Time frame: From the first dose of study drug in Study M20-186 up to 30 days after the last dose of study drug, up to 442 days
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline in Study M19-130: * ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score * No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\]) * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.
Time frame: Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment \[PhGA\], \< 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Time frame: Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
Change From Baseline in Daily Prednisone Dose Over Time
Participants'current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.
Time frame: Baseline of M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104
The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.
Time frame: From Week 56 through Week 104
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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
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