Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE)
Systemic Lupus Erythematosus
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, SLE, Upadacitinib, Lupus
Eligibility Criteria
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: antinuclear antibody (ANA) positive (titer >= 1:80) anti-double stranded deoxyribonucleic acid (dsDNA) positive anti-Smith positive Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) >= 6, of which >= 4 points are clinical (not based on laboratory criteria), independently adjudicated 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 >= 30 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 antimalarial(s) [hydroxychloroquine <= 400 mg daily, chloroquine <= 500 mg daily, quinacrine <= 100 mg daily]; and/or prednisone (or prednisone-equivalent) (<= 20 mg daily); and/or no more than 1 of the following: azathioprine (<= 150 mg daily), mycophenolate mofetil (<= 2 g daily), mycophenolate sodium <= 1,440 mg/day, leflunomide (<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (<= 23.7 mg twice daily), methotrexate (<= 25 mg weekly), or mizoribine (<=150 mg daily) Exclusion Criteria: Clinically relevant or significant ECG abnormalities at Screening. Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.
Sites / Locations
- AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767Recruiting
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820Recruiting
- Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824Recruiting
- AZ Arthritis and Rheumotology Research, PLLC /ID# 252831Recruiting
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825Recruiting
- Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828Recruiting
- David S. Hallegua MD, A Professional Corporation /ID# 253902Recruiting
- Wallace Rheumatic Studies Center, LLC /ID# 252806Recruiting
- Providence Medical Foundation /ID# 252822Recruiting
- Newport Huntington Medical Group /ID# 252827Recruiting
- Millennium Clinical Trials /ID# 252817Recruiting
- Denver Arthritis Clinic /ID# 253189Recruiting
- Arthritis & Rheumatic Disease Specialties /ID# 253624Recruiting
- HARAC Research Corp. /ID# 254922Recruiting
- Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623Recruiting
- Bay Area Arthritis and Osteo /ID# 253597Recruiting
- Clinical Research of West Florida, Inc /ID# 253899Recruiting
- Believe Clinical Trials /ID# 255427Recruiting
- Omega Research Debary, LLC /ID# 254939Recruiting
- Neoclinical Research /ID# 253614Recruiting
- Jacksonville Center for Clinical Research /ID# 257272Recruiting
- UF Health Rheumatology /ID# 255351Recruiting
- Life Clinical Trials /ID# 253615Recruiting
- Lakes Research, LLC /ID# 253621Recruiting
- HMD Research LLC /ID# 253595Recruiting
- Millennium Research /ID# 253600Recruiting
- BayCare Medical Group /ID# 253593Recruiting
- Clinical Research of West Florida - Tampa /ID# 253602Recruiting
- BayCare Medical Group, Inc. /ID# 255135Recruiting
- Atlanta Research Center for Rheumatology /ID# 253610Recruiting
- Crowley CORE, LLC - Hinsdale Orthopaedics /ID# 253018Recruiting
- Greater Chicago Specialty Physicians /ID# 253021Recruiting
- Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 253020Recruiting
- Deerbrook Medical Associates /ID# 253029Recruiting
- AA Medical Research Center - Grand Blanc /ID# 253028Recruiting
- June DO, PC /ID# 253030Recruiting
- Kansas City Physician Partners /ID# 254786Recruiting
- Logan Health Research /ID# 252808Recruiting
- Arthritis and Osteo Assoc /ID# 252818Recruiting
- DJL Clinical Research, PLLC /ID# 253620Recruiting
- Accellacare - Salisbury /ID# 253608Recruiting
- Wake Forest Baptist Health /ID# 254125Recruiting
- Paramount Medical Research Con /ID# 253016Recruiting
- Clinical Research Source, Inc. /ID# 253027Recruiting
- Clinical Research of Philadelphia, LLC /ID# 254156Recruiting
- West Tennessee Research Institute /ID# 252807Recruiting
- Shelby Research /ID# 256937Recruiting
- Arthritis and Rheumatology Research Institute, PLLC /ID# 253014Recruiting
- JPS Rheumatology Clinic /ID# 253185Recruiting
- Arthiritis and Rheumatology Specialists PA /ID# 255950Recruiting
- R & H Clinical Research - 777 Katy /ID# 254126Recruiting
- Valley Arthritis Center /ID# 253022Recruiting
- Trinity Universal Research Associates, Inc /ID# 253013Recruiting
- Sun Research Institute /ID# 255832Recruiting
- DM Clinical Research - Tomball /ID# 255134Recruiting
- Okayama University Hospital /ID# 253821Recruiting
- University of Yamanashi Hospital /ID# 253264Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Study 1- Upadacitinib Dose A
Study 1- Placebo
Study 2- Upadacitinib Dose A
Study 2- Placebo
Study 3- Low Disease Activity Upadacitinib (LDA) Dose A
Study 3- Low Disease Activity Upadacitinib Dose B
Study 3- No LDA Upadacitinib Dose A
Study 3- Upadacitininb Dose A
Study 3- Open Label Upadacitinib Dose A
Study 3- Open Label Upadacitinib Dose B
Participants will receive upadacitinib dose A once daily for 52 weeks.
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Participants will receive upadacitinib dose A once daily for 52 weeks.
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
Participants who experience a suspected systemic lupus erythematosus (SLE) flare may receive open label upadacitinib Dose A once daily for the remainder of the study.
Participants who reach >= 65 years of age and are still on study drug may receive open-label upadacitinib Dose B once daily, and participants who experience a suspected SLE flare while on upadacitinib Dose B may receive upadacitinib Dose A for the remainder of the study.