SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed.
Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world.
Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Inclusion Criteria:
Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.
At Screening, must have at least one of the following:
Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) >= 6, of which >= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as >= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.
Physician's Global Assessment (PhGA) >= 1 during screening period.
On stable background treatment for >= 60 days prior to Baseline (with the exception of oral corticosteroid [OCS], which must be at a stable dose for >=14 days prior to Baseline) with
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Flagstaff, Arizona 86001-6299, United States
Gilbert, Arizona 85297-7336, United States
Glendale, Arizona 85306-9802, United States
Phoenix, Arizona 85032, United States
Tucson, Arizona 85704, United States
Beverly Hills, California 90211, United States
Chula Vista, California 91910, United States
Boca Raton, Florida 33486, United States
Jacksonville, Florida 32216, United States
Tampa, Florida 33606, United States
Tampa, Florida 33606, United States
Marietta, Georgia 30060, United States
Suwanee, Georgia 30024-7290, United States
Chicago, Illinois 60607, United States
Chicago, Illinois 60611-2927, United States
Skokie, Illinois 60076, United States
Lake Charles, Louisiana 70605, United States
Kalispell, Montana 59901, United States
Las Cruces, New Mexico 88011, United States
Brooklyn, New York 11201-5501, United States
Winston-Salem, North Carolina 27157, United States
Allen, Texas 75013-6147, United States
Harlingen, Texas 78550, United States
Ciudad Autonoma Buenos Aires, Buenos Aires 1180, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires 1426, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1015, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1121, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1405, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1958, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Victoria Park, Western Australia 6100, Australia
Anderlecht, Brussels Capital 1070, Belgium
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Vitória, Espírito Santo 29055-450, Brazil
Salvador, Estado de Bahia 40150-150, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
São Paulo, 05403-000, Brazil
Sofiya, Sofia 1407, Bulgaria
Sofiya, Sofia 1463, Bulgaria
Sofiya, Sofia 1463, Bulgaria
Santiago, Region Metropolitana Santiago 8420383, Chile
Beijing, Beijing Municipality 100730, China
Guangzhou, Guangdong 510120, China
Guangzhou, Guangdong 510163, China
Shantou, Guangdong 515041, China
Nanning, Guangxi 530021, China
Luoyang, Henan 471003, China
Wuhan, Hubei 430022, China
Hohhot, Inner Mongolia 010050, China
Shanghai, Shanghai Municipality 200001, China
Hangzhou, Zhejiang 310003, China
Wenzhou, Zhejiang 325000, China
Bogotá, Cundinamarca 110221, Colombia
Bucaramanga, Santander Department 681004, Colombia
Frankfurt am Main, 60596, Germany
Guatemala City, 01010, Guatemala
Guatemala City, zona 10, Guatemala
Veszprém, Fejér 8200, Hungary
Kitakyushu-shi, Fukuoka 807-8556, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Chuo-shi, Yamanashi 409-3898, Japan
Chiba, 260-8712, Japan
Kaunas, 50161, Lithuania
Torreón, Coahuila 27000, Mexico
Guadalajara, Jalisco 44650, Mexico
Mexico City, Mexico City 11850, Mexico
Poznan, Greater Poland Voivodeship 61-545, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-065, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168, Poland
Guilhufe, Porto District 4560-136, Portugal
Ponte de Lima, Viana do Castelo District 4990-041, Portugal
Porto, 4099-001, Portugal
Košice II, 040 11, Slovakia
Cheonan-si, Chungcheongnam-do 31151, South Korea
Gwangju, Gwangju Gwang Yeogsi 61748, South Korea
Seoul, Seoul Teugbyeolsi 06591, South Korea
Basel Town, Canton of Basel-City 4031, Switzerland
Taipei City, Taipei 100, Taiwan
Istanbul, 34899, Turkey (Türkiye)
Meram Konya, 42080, Turkey (Türkiye)
Southampton, Hampshire SO16 6YD, United Kingdom
Northampton, Northamptonshire NN1 5BD, United Kingdom
Londonderry, Northern Ireland BT47 6SB, United Kingdom