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Not recruiting
Phase 3

Upadacitinib

Sponsor:

AbbVie

Code:

NCT05843643

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18 - 63

Healthy Volunteers: Not accepted

Interventions

Upadacitinib

Placebo

Study Details

Brief summary:

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.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT05843643

Start date

Jul 19, 2023

Status verified date

Mar, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 63

Healthy Volunteers: Not accepted

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 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

  • 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), 6-mercaptopurine (<= 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:

  • Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
  • Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
  • SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
  • Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
  • Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
  • History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
  • Pregnancy, breastfeeding, or considering becoming pregnant during the study.
  • 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study 1- Upadacitinib Dose A

Participants will receive upadacitinib dose A once daily for 52 weeks.

placebo comparator: Study 1- Placebo

Participants will receive upadacitinib matching placebo once daily for 52 weeks.

experimental: Study 2- Upadacitinib Dose A

Participants will receive upadacitinib dose A once daily for 52 weeks.

placebo comparator: Study 2- Placebo

Participants will receive upadacitinib matching placebo once daily for 52 weeks.

experimental: Study 3- Low Disease Activity Upadacitinib (LDA) Dose A

Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.

experimental: Study 3- Low Disease Activity Upadacitinib Dose B

Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.

experimental: Study 3- No LDA Upadacitinib Dose A

Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.

experimental: Study 3- Upadacitininb Dose A

Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.

experimental: Study 3- Open Label Upadacitinib Dose A

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.

experimental: Study 3- Open Label Upadacitinib Dose B

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.

experimental: Study 4- Upadacitinib Dose A

Participants receiving upadacitinib Dose A in Study 3 will continue on this dose once daily for 104 weeks.

experimental: Study 4- Upadacitinib Dose B

Participants receiving upadacitinib Dose B in Study 3 will continue on this dose once daily for 104 weeks.

Interventions

Upadacitinib

Oral Tablets

Placebo

Oral Tablet

Primary outcome measure

  • Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response [ Time Frame: At Week 52 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

AZ Arthritis and Rheumatology /ID# 261848

Recruiting

Chandler, Arizona, United States, 85225-2906

AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767

Recruiting

Flagstaff, Arizona, United States, 86001-6299

Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820

Recruiting

Gilbert, Arizona, United States, 85297-7336

Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824

Recruiting

Glendale, Arizona, United States, 85306-9802

Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845

Recruiting

Mesa, Arizona, United States, 85210-6871

Arizona Arthritis & Rheumatology Research /ID# 273555

Recruiting

Peoria, Arizona, United States, 85381

Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831

Recruiting

Phoenix, Arizona, United States, 85032

Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825

Recruiting

Phoenix, Arizona, United States, 85037

Contacts

Site Coordinator

(623) 512-4802

HonorHealth Rheumatology /ID# 261953

Recruiting

Scottsdale, Arizona, United States, 85258-4668

Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828

Recruiting

Tucson, Arizona, United States, 85704

Arthritis and Rheumatism Associates /ID# 253033

Recruiting

Jonesboro, Arkansas, United States, 72401-6251

David S. Hallegua MD, A Professional Corporation /ID# 253902

Recruiting

Beverly Hills, California, United States, 90211

Wallace and Lee Center /ID# 275129

Recruiting

Beverly Hills, California, United States, 90211

Wallace Rheumatic Studies Center, LLC /ID# 252806

Recruiting

Beverly Hills, California, United States, 90211

Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870

Recruiting

Chula Vista, California, United States, 91910

Providence - St. Jude Medical Center /ID# 252822

Recruiting

Fullerton, California, United States, 92835

Private Practice - Dr. Chandrakant V. Mehta /ID# 275100

Recruiting

Hemet, California, United States, 92543

Newport Huntington Medical Group /ID# 252827

Recruiting

Huntington Beach, California, United States, 92648-5994

Moores Cancer Center at UC San Diego /ID# 253903

Recruiting

La Jolla, California, United States, 92093

Arthritis & Osteo Medical Ctr /ID# 252812

Recruiting

La Palma, California, United States, 90623-1728

Contacts

Site Coordinator

714-670-1340

Wagdy Kades, M.D., Inc /ID# 272065

Recruiting

Los Angeles, California, United States, 90017

Providence St. Johns Health Center /ID# 253905

Recruiting

Santa Monica, California, United States, 90404-2303

Millennium Clinical Trials /ID# 252817

Recruiting

Thousand Oaks, California, United States, 91360-3951

Cohen Medical Centers /ID# 268524

Recruiting

Thousand Oaks, California, United States, 91360

Solace Research /ID# 275198

Recruiting

Tustin, California, United States, 92780

Upland Rheumatology Center /ID# 268623

Recruiting

Upland, California, United States, 91786

University of Colorado Hospital /ID# 253184

Recruiting

Aurora, Colorado, United States, 80045

Yale University School of Medicine /ID# 254567

Recruiting

New Haven, Connecticut, United States, 06510

Arthritis and Rheumatic Disease Specialties /ID# 253624

Recruiting

Aventura, Florida, United States, 33180

Contacts

Site Coordinator

305-932-4162

HARAC Research Corp. /ID# 254922

Recruiting

Avon Park, Florida, United States, 33825-2958

Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

Site Coordinator

561-361-6547

Mdr Core Network, Inc /Id# 276704

Recruiting

Boynton Beach, Florida, United States, 33426

Bay Area Arthritis and Osteo /ID# 253597

Recruiting

Brandon, Florida, United States, 33511

Contacts

Site Coordinator

813-651-4441

GNP Consultants, dba, GNP Research /ID# 272868

Recruiting

Cooper City, Florida, United States, 33024

Contacts

Site Coordinator

954-441-9995

International Medical Research /ID# 253617

Recruiting

Daytona Beach, Florida, United States, 32117

Omega Research Debary, LLC /ID# 254939

Recruiting

DeBary, Florida, United States, 32713-2260

University of Florida /ID# 261984

Recruiting

Gainesville, Florida, United States, 32610-3008

Finlay Medical Research - Greenacres /ID# 274902

Recruiting

Greenacres City, Florida, United States, 33467

Evolution Research Center /ID# 272991

Recruiting

Hialeah, Florida, United States, 33012

Neoclinical Research /ID# 253614

Recruiting

Hialeah, Florida, United States, 33016-1897

Contacts

Site Coordinator

1-305-456-9062

South Florida Rheumatology /ID# 268525

Recruiting

Hollywood, Florida, United States, 33026

Encore Research Group-Jacksonville Center for Clinical Research /ID# 257272

Recruiting

Jacksonville, Florida, United States, 32216

UF Health Rheumatology /ID# 255351

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Site Coordinator

904-633-0071

Life Clinical Trials /ID# 253615

Recruiting

Margate, Florida, United States, 33063

University of Miami, Division of Rheumatology /ID# 261594

Recruiting

Miami, Florida, United States, 33136-2107

Ezy Medical Research /ID# 276221

Recruiting

Miami, Florida, United States, 33175

HMD Research LLC /ID# 253595

Recruiting

Orlando, Florida, United States, 32819

University of Central Florida /ID# 261112

Recruiting

Orlando, Florida, United States, 32827-7664

Millennium Research /ID# 253600

Recruiting

Ormond Beach, Florida, United States, 32174

Vitalia Research /ID# 272642

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Contacts

Site Coordinator

561-559-1110

Believe Clinical Trials /ID# 277004

Recruiting

Plant City, Florida, United States, 33563

IRIS Research and Development, LLC /ID# 253618

Recruiting

Plantation, Florida, United States, 33324

BayCare Medical Group /ID# 253593

Recruiting

St. Petersburg, Florida, United States, 33705

Contacts

Site Coordinator

727-824-3147

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253602

Recruiting

Tampa, Florida, United States, 33606

Contacts

Site Coordinator

813-870-1292

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253899

Recruiting

Tampa, Florida, United States, 33606

Baycare Medical Group - Tampa /ID# 255135

Recruiting

Tampa, Florida, United States, 33614

Contacts

Site Coordinator

813-840-3600

Emory University School Of Medicine - Atlanta /ID# 261529

Recruiting

Atlanta, Georgia, United States, 30322

Trinity Research Centers /ID# 262039

Recruiting

Kennesaw, Georgia, United States, 30144-1762

Atlanta Research Center For Rheumatology - Marietta /ID# 253610

Recruiting

Marietta, Georgia, United States, 30060

Arthritis and Rheumatology Center PC /ID# 275994

Recruiting

Roswell, Georgia, United States, 30076

Immunology and Rheumatology Research Associates LLC /ID# 267582

Recruiting

Suwanee, Georgia, United States, 30024-7290

University of Illinois Hospital and Health Sciences System /ID# 263014

Recruiting

Chicago, Illinois, United States, 60607

Northwestern University Feinberg School of Medicine /ID# 264090

Recruiting

Chicago, Illinois, United States, 60611-2927

Next Innovative Clinical Research - Chicago /ID# 268739

Recruiting

Chicago, Illinois, United States, 60616

Contacts

Site Coordinator

773-825-3370

University of Chicago Medical Center /ID# 263162

Recruiting

Chicago, Illinois, United States, 60637

Illinois Bone & Joint Institute - Morton /ID# 274455

Recruiting

Morton, Illinois, United States, 60053

Advanced Quality Medical Research /ID# 254983

Recruiting

Orland Park, Illinois, United States, 60462

OrthoIllinois /ID# 253188

Recruiting

Rockford, Illinois, United States, 61114-4937

Greater Chicago Specialty Physicians /ID# 253021

Recruiting

Schaumburg, Illinois, United States, 60195-3106

Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253020

Recruiting

Skokie, Illinois, United States, 60076

Deerbrook Medical Associates /ID# 253029

Recruiting

Vernon Hills, Illinois, United States, 60061

Willow Rheumatology and Wellness, PLLC /ID# 253018

Recruiting

Willowbrook, Illinois, United States, 60527

Western KY Rheumatology /ID# 254937

Recruiting

Hopkinsville, Kentucky, United States, 42240

Accurate Clinical Research (SMO/Network/Consortium) /ID# 272647

Recruiting

Lake Charles, Louisiana, United States, 70605

Willis Knighton /ID# 256343

Recruiting

Shreveport, Louisiana, United States, 71103-3920

University of Maryland, Baltimore /ID# 262556

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Coordinator

410-706-6474

UMass Memorial Medical Center /ID# 262742

Recruiting

Worcester, Massachusetts, United States, 01655

Clinical Research Institute Of Michigan /ID# 273051

Recruiting

Clinton Township, Michigan, United States, 48038

AA Medical Research Center - Grand Blanc /ID# 253028

Recruiting

Grand Blanc, Michigan, United States, 48439

Kansas City Physician Partners /ID# 254786

Recruiting

Kansas City, Missouri, United States, 64151

Inspire Santa Fe Medical Group /ID# 275947

Recruiting

Santa Fe, New Mexico, United States, 87505

Joseph S. and Diane H. Steinberg Ambulatory Care Center /ID# 253592

Recruiting

Brooklyn, New York, United States, 11201-5501

NYU Langone Orthopedic Center /ID# 253613

Recruiting

New York, New York, United States, 10016-2772

St. Lawrence Health System /ID# 253598

Recruiting

Potsdam, New York, United States, 13676

Urban Health Plan /ID# 268059

Recruiting

The Bronx, New York, United States, 10459

Joint And Muscle Research Institute /ID# 272845

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Site Coordinator

(704) 377-1216

DJL Clinical Research, PLLC /ID# 253620

Recruiting

Charlotte, North Carolina, United States, 28211

Raleigh Medical Group /ID# 256328

Recruiting

Raleigh, North Carolina, United States, 27609

Accellacare - Salisbury /ID# 253608

Recruiting

Salisbury, North Carolina, United States, 28144-2735

Contacts

Site Coordinator

7046479913

Atrium Health Wake Forest Baptist Medical Center /ID# 254125

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Coordinator

336-713-4379

University of Cincinnati Medical Center /ID# 259174

Recruiting

Cincinnati, Ohio, United States, 45219-2364

Paramount Medical Research and Consulting /ID# 253016

Recruiting

Middleburg Heights, Ohio, United States, 44130

Oklahoma Medical Research Foundation /ID# 263509

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Rheumatology Associates of Oklahoma /ID# 253012

Recruiting

Oklahoma City, Oklahoma, United States, 73116-7226

Albert Einstein Medical Center /ID# 256661

Recruiting

Philadelphia, Pennsylvania, United States, 19141

University of Pittsburgh Medical Center /ID# 263686

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Low Country Rheumatology /ID# 272956

Recruiting

Summerville, South Carolina, United States, 29486

Contacts

Site Coordinator

843-572-4840 x7405

West Tennessee Research Institute /ID# 252807

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Site Coordinator

731-664-0002

Shelby Research /ID# 256937

Recruiting

Memphis, Tennessee, United States, 38119

Arthritis and Rheumatology Research Institute, PLLC /ID# 253014

Recruiting

Allen, Texas, United States, 75013-6147

Rheumatology Associates /ID# 276066

Recruiting

Arlington, Texas, United States, 76012

Arthritis Care of Texas /ID# 261719

Recruiting

Corpus Christi, Texas, United States, 78415-1800

Texas Arthritis Center /ID# 277049

Recruiting

El Paso, Texas, United States, 79902

Contacts

Site Coordinator

915-317-1660

JPS Rheumatology Clinic /ID# 253185

Recruiting

Fort Worth, Texas, United States, 76104-4917

Arthiritis and Rheumatology Specialists PA /ID# 255950

Recruiting

Fort Worth, Texas, United States, 76177

Contacts

Site Coordinator

940-626-8073

Integrative Rheumatology of South Texas - Harlingen /ID# 261977

Recruiting

Harlingen, Texas, United States, 78550

Contacts

Site Coordinator

956-423-1112

Accurate Clinical Research - Houston /ID# 276220

Recruiting

Houston, Texas, United States, 77089-6142

Accurate Clinical Research Katy /ID# 276459

Recruiting

Katy, Texas, United States, 77449

R & H Clinical Research - 777 Katy /ID# 254126

Recruiting

Katy, Texas, United States, 77450-2244

Biopharma Informatic /ID# 273651

Recruiting

Katy, Texas, United States, 77494

Valley Arthritis Center /ID# 253022

Recruiting

McAllen, Texas, United States, 78501-1401

Texas Rheumatology Research Institute Llc /Id# 253013

Recruiting

Plano, Texas, United States, 75024

Epic Medical Research /ID# 255326

Recruiting

Red Oak, Texas, United States, 75154

Contacts

Site Coordinator

972-777-6956

Sun Research Institute /ID# 255832

Recruiting

San Antonio, Texas, United States, 78215

Contacts

Site Coordinator

210-227-1289

Clinical Trials of Texas, Inc /ID# 254949

Recruiting

San Antonio, Texas, United States, 78229

Epic Medical Research- San Marcos /ID# 278360

Recruiting

San Marcos, Texas, United States, 78666

Fort Bend Rheumatology Associates, PLLC /ID# 268492

Recruiting

Sugar Land, Texas, United States, 77479

DM Clinical Research - Tomball /ID# 255134

Recruiting

Tomball, Texas, United States, 77375

Carilion Roanoke Memorial Hospital /ID# 253374

Recruiting

Roanoke, Virginia, United States, 24014

Rheumatology & Pulmonary Clinic /ID# 273561

Recruiting

Beckley, West Virginia, United States, 25801

Wisconsin Medical Center /ID# 256660

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Coordinator

414-955-7836

University of Calgary /ID# 259515

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

University of Alberta Hospital /ID# 259516

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

University of Manitoba /ID# 259517

Recruiting

Winnipeg, Manitoba, Canada, R3A 1M4

Toronto Western Hospital /ID# 254017

Recruiting

Toronto, Ontario, Canada, M5T 2S8

CIUSSS de l'Estrie - CHUS /ID# 254716

Recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

More Information

Sponsor

AbbVie

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • Systemic Lupus Erythematosus
  • SLE
  • Upadacitinib
  • Lupus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by AbbVie on 2026-03-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.