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)
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.
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona 85032-9306, United States
Los Alamitos, California 90720-5402, United States
Aventura, Florida 33180, United States
New York, New York 10016-2772, United States
Pittsburgh, Pennsylvania 15224, United States
Ciudad Autonoma Buenos Aires, Buenos Aires 1426, Argentina
La Plata, Buenos Aires 1900, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1958, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Beijing, Beijing Municipality 100730, China
Urumqi, Guizhou 830001, China
Barranquilla, Atlántico 80002, Colombia
Bogota, Cundinamarca 110221, Colombia
Medellin, Valle del Cauca Department 050034, Colombia
Cona, Ferrara 44124, Italy
Kitakyushu-shi, Fukuoka 807-8556, Japan
Hiroshima, Hiroshima 730-8619, Japan
Asahikawa-shi, Hokkaido 070-8644, Japan
Matsumoto-shi, Nagano 390-8621, Japan
Kawagoe-shi, Saitama 350-8550, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Guadalajara, Jalisco 44690, Mexico
Mexico City, Mexico City 11850, Mexico
Poznan, Greater Poland Voivodeship 61-545, Poland
Krakow, Lesser Poland Voivodeship 31-011, Poland
Wroclaw, Lower Silesian Voivodeship 51-685, Poland
Taipei City, Taipei 100, Taiwan