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
Public ClinicalTrials.gov record NCT04451772. 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
A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)
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 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.
Study identification
- NCT ID
- NCT04451772
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 185 participants
Conditions and interventions
Conditions
Interventions
- Elsubrutinib Drug
- Placebo for Elsubrutinib Drug
- Upadacitinib Drug
- Placebo for Upadacitinib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 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 27, 2020 (Actual)
- Primary completion
- Jan 3, 2024 (Actual)
- Completion
- Jan 3, 2024 (Actual)
- Last update posted
- Jan 14, 2025
2020 – 2024
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 227833 | Phoenix | Arizona | 85032-9306 | — |
| Wallace Rheumatic Studies Center, LLC /ID# 224374 | Beverly Hills | California | 90211 | — |
| Valerius Medical Group & Research Center /ID# 223922 | Los Alamitos | California | 90720-5402 | — |
| East Bay Rheumatology Medical /ID# 225493 | San Leandro | California | 94578 | — |
| University of Colorado Hospital /ID# 245087 | Aurora | Colorado | 80045 | — |
| Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 227828 | Aventura | Florida | 33180 | — |
| Millennium Research /ID# 233192 | Ormond Beach | Florida | 32174 | — |
| IRIS Research and Development, LLC /ID# 227814 | Plantation | Florida | 33324 | — |
| Deerbrook Medical Associates /ID# 227330 | Libertyville | Illinois | 60048 | — |
| Qualmedica Research, LLC /ID# 227817 | Evansville | Indiana | 47714-0805 | — |
| The Center for Rheumatology and Bone Research /ID# 225479 | Wheaton | Maryland | 20902 | — |
| Beth Israel Deaconess Medical Center /ID# 222505 | Boston | Massachusetts | 02215-5400 | — |
| June DO, PC /ID# 221841 | Lansing | Michigan | 48911 | — |
| Duplicate_NYU Langone Health/NYU School of Medicine /ID# 245088 | New York | New York | 10016-2772 | — |
| STAT Research, Inc. /ID# 221840 | Vandalia | Ohio | 45377-9464 | — |
| Allegheny Health Network Research Institute /ID# 245086 | Pittsburgh | Pennsylvania | 15224 | — |
| Dr. Ramesh Gupta /ID# 225524 | Memphis | Tennessee | 38119 | — |
| Tekton Research, Inc. /ID# 224411 | Austin | Texas | 78745 | — |
| Accurate Clinical Management /ID# 225509 | Houston | Texas | 77084 | — |
| SW Rheumatology Res. LLC /ID# 225485 | Mesquite | Texas | 75150 | — |
| Carilion Clinic /ID# 227832 | Roanoke | Virginia | 24016 | — |
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 66 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04451772, 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 Jan 14, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04451772 live on ClinicalTrials.gov.