Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
Public ClinicalTrials.gov record NCT05843643. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05843643
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,014 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 63 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 25, 2023 (Actual)
- Primary completion
- Mar 2027 (Estimated)
- Completion
- Oct 2027 (Estimated)
- Last update posted
- Apr 28, 2026
2023 – 2027
United States locations
- U.S. sites
- 132
- U.S. states
- 28
- U.S. cities
- 110
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AZ Arthritis and Rheumatology /ID# 261848 | Chandler | Arizona | 85225-2906 | — |
| AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767 | Flagstaff | Arizona | 86001-6299 | — |
| Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820 | Gilbert | Arizona | 85297-7336 | — |
| Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824 | Glendale | Arizona | 85306-9802 | — |
| Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845 | Mesa | Arizona | 85210-6871 | — |
| Arizona Arthritis & Rheumatology Research /ID# 273555 | Peoria | Arizona | 85381 | — |
| Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831 | Phoenix | Arizona | 85032 | — |
| Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825 | Phoenix | Arizona | 85037 | — |
| HonorHealth Rheumatology /ID# 261953 | Scottsdale | Arizona | 85258-4668 | — |
| Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828 | Tucson | Arizona | 85704 | — |
| Arthritis and Rheumatism Associates /ID# 253033 | Jonesboro | Arkansas | 72401-6251 | — |
| Kaiser Permanente Lakeview Medical Offices /ID# 253906 | Anaheim | California | 92807-3028 | — |
| David S. Hallegua MD, A Professional Corporation /ID# 253902 | Beverly Hills | California | 90211 | — |
| Wallace and Lee Center /ID# 275129 | Beverly Hills | California | 90211 | — |
| Wallace Rheumatic Studies Center, LLC /ID# 252806 | Beverly Hills | California | 90211 | — |
| Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870 | Chula Vista | California | 91910 | — |
| Providence - St. Jude Medical Center /ID# 252822 | Fullerton | California | 92835 | — |
| Private Practice - Dr. Chandrakant V. Mehta /ID# 275100 | Hemet | California | 92543 | — |
| Newport Huntington Medical Group /ID# 252827 | Huntington Beach | California | 92648-5994 | — |
| Moores Cancer Center at UC San Diego /ID# 253903 | La Jolla | California | 92093 | — |
| Arthritis & Osteo Medical Ctr /ID# 252812 | La Palma | California | 90623-1728 | — |
| Wagdy Kades, M.D., Inc /ID# 272065 | Los Angeles | California | 90017 | — |
| Providence St. Johns Health Center /ID# 253905 | Santa Monica | California | 90404-2303 | — |
| Millennium Clinical Trials /ID# 252817 | Thousand Oaks | California | 91360-3951 | — |
| Cohen Medical Centers /ID# 268524 | Thousand Oaks | California | 91360 | — |
| Solace Research /ID# 275198 | Tustin | California | 92780 | — |
| Upland Rheumatology Center /ID# 268623 | Upland | California | 91786 | — |
| University of Colorado Hospital /ID# 253184 | Aurora | Colorado | 80045 | — |
| Denver Arthritis Clinic /ID# 253189 | Denver | Colorado | 80230 | — |
| Yale University School of Medicine /ID# 254567 | New Haven | Connecticut | 06510 | — |
| Arthritis and Rheumatic Disease Specialties /ID# 253624 | Aventura | Florida | 33180 | — |
| HARAC Research Corp. /ID# 254922 | Avon Park | Florida | 33825-2958 | — |
| Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623 | Boca Raton | Florida | 33486 | — |
| Mdr Core Network, Inc /Id# 276704 | Boynton Beach | Florida | 33426 | — |
| Bay Area Arthritis and Osteo /ID# 253597 | Brandon | Florida | 33511 | — |
| GNP Consultants, dba, GNP Research /ID# 272868 | Cooper City | Florida | 33024 | — |
| Duplicate_Believe Clinical Trials /ID# 255427 | Coral Springs | Florida | 33065 | — |
| International Medical Research /ID# 253617 | Daytona Beach | Florida | 32117 | — |
| Omega Research Debary, LLC /ID# 254939 | DeBary | Florida | 32713-2260 | — |
| University of Florida /ID# 261984 | Gainesville | Florida | 32610-3008 | — |
| Finlay Medical Research - Greenacres /ID# 274902 | Greenacres City | Florida | 33467 | — |
| Evolution Research Center /ID# 272991 | Hialeah | Florida | 33012 | — |
| Neoclinical Research /ID# 253614 | Hialeah | Florida | 33016-1897 | — |
| South Florida Rheumatology /ID# 268525 | Hollywood | Florida | 33026 | — |
| Encore Research Group-Jacksonville Center for Clinical Research /ID# 257272 | Jacksonville | Florida | 32216 | — |
| UF Health Rheumatology /ID# 255351 | Jacksonville | Florida | 32256 | — |
| Life Clinical Trials /ID# 253615 | Margate | Florida | 33063 | — |
| Lakes Research, LLC /ID# 253621 | Miami | Florida | 33014 | — |
| University of Miami, Division of Rheumatology /ID# 261594 | Miami | Florida | 33136-2107 | — |
| Ezy Medical Research /ID# 276221 | Miami | Florida | 33175 | — |
| HMD Research LLC /ID# 253595 | Orlando | Florida | 32819 | — |
| University of Central Florida /ID# 261112 | Orlando | Florida | 32827-7664 | — |
| Millennium Research /ID# 253600 | Ormond Beach | Florida | 32174 | — |
| Vitalia Research /ID# 272642 | Palm Beach Gardens | Florida | 33410 | — |
| Believe Clinical Trials /ID# 277004 | Plant City | Florida | 33563 | — |
| IRIS Research and Development, LLC /ID# 253618 | Plantation | Florida | 33324 | — |
| BayCare Medical Group /ID# 253593 | St. Petersburg | Florida | 33705 | — |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253602 | Tampa | Florida | 33606 | — |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253899 | Tampa | Florida | 33606 | — |
| Baycare Medical Group - Tampa /ID# 255135 | Tampa | Florida | 33614 | — |
| Emory University School Of Medicine - Atlanta /ID# 261529 | Atlanta | Georgia | 30322 | — |
| Trinity Research Centers /ID# 262039 | Kennesaw | Georgia | 30144-1762 | — |
| Atlanta Research Center For Rheumatology - Marietta /ID# 253610 | Marietta | Georgia | 30060 | — |
| Arthritis and Rheumatology Center PC /ID# 275994 | Roswell | Georgia | 30076 | — |
| Immunology and Rheumatology Research Associates LLC /ID# 267582 | Suwanee | Georgia | 30024-7290 | — |
| University of Illinois Hospital and Health Sciences System /ID# 263014 | Chicago | Illinois | 60607 | — |
| Northwestern University Feinberg School of Medicine /ID# 264090 | Chicago | Illinois | 60611-2927 | — |
| Next Innovative Clinical Research - Chicago /ID# 268739 | Chicago | Illinois | 60616 | — |
| University of Chicago Medical Center /ID# 263162 | Chicago | Illinois | 60637 | — |
| Illinois Bone & Joint Institute - Morton /ID# 274455 | Morton | Illinois | 60053 | — |
| Advanced Quality Medical Research /ID# 254983 | Orland Park | Illinois | 60462 | — |
| OrthoIllinois /ID# 253188 | Rockford | Illinois | 61114-4937 | — |
| Greater Chicago Specialty Physicians /ID# 253021 | Schaumburg | Illinois | 60195-3106 | — |
| Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253020 | Skokie | Illinois | 60076 | — |
| NorthShore University HealthSystem - Skokie /ID# 254568 | Skokie | Illinois | 60077 | — |
| Deerbrook Medical Associates /ID# 253029 | Vernon Hills | Illinois | 60061 | — |
| Willow Rheumatology and Wellness, PLLC /ID# 253018 | Willowbrook | Illinois | 60527 | — |
| Western KY Rheumatology /ID# 254937 | Hopkinsville | Kentucky | 42240 | — |
| Accurate Clinical Research (SMO/Network/Consortium) /ID# 272647 | Lake Charles | Louisiana | 70605 | — |
| Willis Knighton /ID# 256343 | Shreveport | Louisiana | 71103-3920 | — |
| University of Maryland, Baltimore /ID# 262556 | Baltimore | Maryland | 21201 | — |
| UMass Memorial Medical Center /ID# 262742 | Worcester | Massachusetts | 01655 | — |
| Clinical Research Institute Of Michigan /ID# 273051 | Clinton Township | Michigan | 48038 | — |
| AA Medical Research Center - Grand Blanc /ID# 253028 | Grand Blanc | Michigan | 48439 | — |
| June DO, PC /ID# 253030 | Lansing | Michigan | 48911 | — |
| Kansas City Physician Partners /ID# 254786 | Kansas City | Missouri | 64151 | — |
| Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 252808 | Kalispell | Montana | 59901 | — |
| Dartmouth-Hitchcock Medical Center /ID# 254923 | Lebanon | New Hampshire | 03756 | — |
| Arthritis and Osteoporosis Associates of New Mexico /ID# 252818 | Las Cruces | New Mexico | 88011 | — |
| Inspire Santa Fe Medical Group /ID# 275947 | Santa Fe | New Mexico | 87505 | — |
| Joseph S. and Diane H. Steinberg Ambulatory Care Center /ID# 253592 | Brooklyn | New York | 11201-5501 | — |
| NYU Langone Orthopedic Center /ID# 253613 | New York | New York | 10016-2772 | — |
| St. Lawrence Health System /ID# 253598 | Potsdam | New York | 13676 | — |
| Urban Health Plan /ID# 268059 | The Bronx | New York | 10459 | — |
| Joint And Muscle Research Institute /ID# 272845 | Charlotte | North Carolina | 28204 | — |
| DJL Clinical Research, PLLC /ID# 253620 | Charlotte | North Carolina | 28211 | — |
| Raleigh Medical Group /ID# 256328 | Raleigh | North Carolina | 27609 | — |
| Accellacare - Salisbury /ID# 253608 | Salisbury | North Carolina | 28144-2735 | — |
| Atrium Health Wake Forest Baptist Medical Center /ID# 254125 | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati Medical Center /ID# 259174 | Cincinnati | Ohio | 45219-2364 | — |
| Paramount Medical Research and Consulting /ID# 253016 | Middleburg Heights | Ohio | 44130 | — |
| Clinical Research Source, Inc. /ID# 253027 | Perrysburg | Ohio | 43551 | — |
| Oklahoma Medical Research Foundation /ID# 263509 | Oklahoma City | Oklahoma | 73104 | — |
| Rheumatology Associates of Oklahoma /ID# 253012 | Oklahoma City | Oklahoma | 73116-7226 | — |
| Clinical Research of Philadelphia, LLC /ID# 254156 | Philadelphia | Pennsylvania | 19114 | — |
| Albert Einstein Medical Center /ID# 256661 | Philadelphia | Pennsylvania | 19141 | — |
| University of Pittsburgh Medical Center /ID# 263686 | Pittsburgh | Pennsylvania | 15213 | — |
| Low Country Rheumatology /ID# 272956 | Summerville | South Carolina | 29486 | — |
| West Tennessee Research Institute /ID# 252807 | Jackson | Tennessee | 38305 | — |
| Shelby Research /ID# 256937 | Memphis | Tennessee | 38119 | — |
| Arthritis and Rheumatology Research Institute, PLLC /ID# 253014 | Allen | Texas | 75013-6147 | — |
| Rheumatology Associates /ID# 276066 | Arlington | Texas | 76012 | — |
| Arthritis Care of Texas /ID# 261719 | Corpus Christi | Texas | 78415-1800 | — |
| Texas Arthritis Center /ID# 277049 | El Paso | Texas | 79902 | — |
| JPS Rheumatology Clinic /ID# 253185 | Fort Worth | Texas | 76104-4917 | — |
| Arthiritis and Rheumatology Specialists PA /ID# 255950 | Fort Worth | Texas | 76177 | — |
| Integrative Rheumatology of South Texas - Harlingen /ID# 261977 | Harlingen | Texas | 78550 | — |
| Accurate Clinical Research - Houston /ID# 276220 | Houston | Texas | 77089-6142 | — |
| Accurate Clinical Research Katy /ID# 276459 | Katy | Texas | 77449 | — |
| R & H Clinical Research - Katy /ID# 254126 | Katy | Texas | 77450-2244 | — |
| Biopharma Informatic /ID# 273651 | Katy | Texas | 77494 | — |
| Valley Arthritis Center /ID# 253022 | McAllen | Texas | 78501-1401 | — |
| Texas Rheumatology Research Institute Llc /Id# 253013 | Plano | Texas | 75024 | — |
| Epic Medical Research /ID# 255326 | Red Oak | Texas | 75154 | — |
| Sun Research Institute /ID# 255832 | San Antonio | Texas | 78215 | — |
| Clinical Trials of Texas, Inc /ID# 254949 | San Antonio | Texas | 78229 | — |
| Epic Medical Research- San Marcos /ID# 278360 | San Marcos | Texas | 78666 | — |
| Fort Bend Rheumatology Associates, PLLC /ID# 268492 | Sugar Land | Texas | 77479 | — |
| DM Clinical Research - Tomball /ID# 255134 | Tomball | Texas | 77375 | — |
| Carilion Roanoke Memorial Hospital /ID# 253374 | Roanoke | Virginia | 24014 | — |
| Rheumatology & Pulmonary Clinic /ID# 273561 | Beckley | West Virginia | 25801 | — |
| Wisconsin Medical Center /ID# 256660 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 237 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05843643, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05843643 live on ClinicalTrials.gov.