A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus (SLE)

In brief

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.

Key facts

Study ID

NCT03978520

Run by

AbbVie

People needed

341

Starts

2019-07-25

Expected to finish

2022-07-14

Last updated by the study team

2023-07-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• antinuclear antibody (ANA)+ (titer ≥ 1:80)
• anti-dsDNA+
• anti-Smith+
• 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:
• If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.
• If participant has rash and Principal Investigator (PI) considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.
• Score must be re-confirmed at the Baseline visit.
• 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).
• No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.

You may not qualify if…

• 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.

Where it is running

• AZ Arthritis and Rheumotology Research, PLLC /ID# 211329 — Phoenix, Arizona, United States
• AZ Arthritis and Rheumotology Research, PLLC /ID# 214267 — Phoenix, Arizona, United States
• Arthritis and Rheumatism Associates /ID# 211411 — Jonesboro, Arkansas, United States
• Wallace Rheumatic Studies Center, LLC /ID# 211600 — Beverly Hills, California, United States
• Arthritis & Osteo Medical Ctr /ID# 228235 — La Palma, California, United States
• Valerius Medical Group & Research Center /ID# 211599 — Los Alamitos, California, United States
• East Bay Rheumatology Medical /ID# 211638 — San Leandro, California, United States
• The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402 — Torrance, California, United States
• Medvin Clinical Research /ID# 211996 — Tujunga, California, United States
• Inland Rheum Clin Trials Inc. /ID# 213617 — Upland, California, United States
• University of Colorado Hospital /ID# 211314 — Aurora, Colorado, United States
• Yale University /ID# 212824 — New Haven, Connecticut, United States
• Medstar Health Research Institute /ID# 213335 — Washington D.C., District of Columbia, United States
• Arthritis & Rheumatic Disease Specialties /ID# 214052 — Aventura, Florida, United States
• LeJenue Research Associates /ID# 212327 — Miami, Florida, United States
• Ctr Arthritis & Rheumatic Dise /ID# 212326 — Miami, Florida, United States
• Millennium Research /ID# 219099 — Ormond Beach, Florida, United States
• IRIS Research and Development, LLC /ID# 213053 — Plantation, Florida, United States
• West Broward Rheumatology Associates /ID# 211881 — Tamarac, Florida, United States
• BayCare Medical Group, Inc. /ID# 218818 — Tampa, Florida, United States
• Affinity Clinical Research /ID# 211496 — Oak Brook, Illinois, United States
• Deerbrook Medical Associates /ID# 212251 — Vernon Hills, Illinois, United States
• Qualmedica Research, LLC /ID# 214765 — Evansville, Indiana, United States
• University of Iowa Hospitals and Clinics /ID# 215246 — Iowa City, Iowa, United States
• Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522 — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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