A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
Inclusion Criteria:
Participant has clinical diagnosis of Systemic Lupus Erythematosus (SLE) at least 24 weeks prior to Screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.
At Screening, must have at least one of the following:
SLEDAI-2K (SLE Disease Activity Index) ≥ 6 despite background therapy as reported and independently adjudicated (clinical score ≥ 4, excluding lupus headache and/or organic brain syndrome) at Screening:
Physician's Global Assessment (PhGA) ≥ 1 during screening period.
Must be on background treatment, stable for 30 days prior to Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (≤ 20 mg), azathioprine (≤ 150 mg), mycophenolate (<2 g), leflunomide (≤ 20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (≤ 20 mg).
Exclusion Criteria:
- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.
Los Alamitos, California 90720-5402, United States
Torrance, California 90502, United States
Washington D.C., District of Columbia 20010, United States
Pittsburgh, Pennsylvania 15224, United States
Carrollton, Texas 75007, United States
Ciudad Autonoma Buenos Aires, Buenos Aires 1426, Argentina
La Plata, Buenos Aires 1900, Argentina
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1046, Argentina
Rosario, Santa Fe Province 2000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Fitzroy Melbourne, Victoria 3065, Australia
Hamilton, Ontario L8S 4K1, Canada
Barranquilla, Atlántico 80002, Colombia
Bogota, Cundinamarca 110221, Colombia
Kiel, Schleswig-Holstein 24105, Germany
Veszprém, Veszprém megye 8200, Hungary
Cona, Ferrara 44124, Italy
Udine, 33100, Italy
Kitakyushu-shi, Fukuoka 807-8556, Japan
Hiroshima, Hiroshima 730-8619, Japan
Asahikawa-shi, Hokkaido 070-8644, Japan
Tomakomai-shi, Hokkaido 053-0034, Japan
Ono-shi, HyĹŤgo 675-1327, 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
San Luis PotosĂ City, San Luis PotosĂ 78213, Mexico
Poznan, Greater Poland Voivodeship 61-545, Poland
Krakow, Lesser Poland Voivodeship 31-011, Poland
Wroclaw, Lower Silesian Voivodeship 51-685, Poland