A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus (SLE)

In brief

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide. Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study. Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key facts

Study ID

NCT04451772

Run by

AbbVie

People needed

185

Starts

2020-07-27

Expected to finish

2024-01-03

Last updated by the study team

2025-01-14

Who can join

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

You may qualify if…

• Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matching placebo) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study.
• On stable background treatment for SLE throughout the study.

You may not qualify if…

• Active, chronic, or recurrent viral, or bacterial infection.
• Active tuberculosis (TB)
• History of gastrointestinal (GI) perforation, diverticulitis, or a significantly increased risk for GI perforation per investigator assessment.
• Participant require vaccination with live vaccine during study participation.

Where it is running

• Wallace Rheumatic Studies Center, LLC /ID# 224374 — Beverly Hills, California, United States
• Valerius Medical Group & Research Center /ID# 223922 — Los Alamitos, California, United States
• East Bay Rheumatology Medical /ID# 225493 — San Leandro, California, United States
• University of Colorado Hospital /ID# 245087 — Aurora, Colorado, United States
• Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 227828 — Aventura, Florida, United States
• Millennium Research /ID# 233192 — Ormond Beach, Florida, United States
• IRIS Research and Development, LLC /ID# 227814 — Plantation, Florida, United States
• Deerbrook Medical Associates /ID# 227330 — Libertyville, Illinois, United States
• Qualmedica Research, LLC /ID# 227817 — Evansville, Indiana, United States
• The Center for Rheumatology and Bone Research /ID# 225479 — Wheaton, Maryland, United States
• Beth Israel Deaconess Medical Center /ID# 222505 — Boston, Massachusetts, United States
• June DO, PC /ID# 221841 — Lansing, Michigan, United States
• Duplicate_NYU Langone Health/NYU School of Medicine /ID# 245088 — New York, New York, United States
• STAT Research, Inc. /ID# 221840 — Vandalia, Ohio, United States
• Allegheny Health Network Research Institute /ID# 245086 — Pittsburgh, Pennsylvania, United States
• Dr. Ramesh Gupta /ID# 225524 — Memphis, Tennessee, United States
• Tekton Research, Inc. /ID# 224411 — Austin, Texas, United States
• Accurate Clinical Management /ID# 225509 — Houston, Texas, United States
• SW Rheumatology Res. LLC /ID# 225485 — Mesquite, Texas, United States
• Carilion Clinic /ID# 227832 — Roanoke, Virginia, United States
• Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 222569 — Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
• Hospital Interzonal General de Agudos General Jose de San Martin /ID# 221893 — La Plata, Buenos Aires, Argentina
• CER Instituto Medico /ID# 223175 — Quilmes, Buenos Aires, Argentina
• Aprillus Asistencia e Investigacion /ID# 221890 — Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
• Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 227833 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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