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
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|ClinicalTrials.gov Identifier: NCT04451772|
Recruitment Status : Active, not recruiting
First Posted : June 30, 2020
Last Update Posted : January 18, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus (SLE)||Drug: Elsubrutinib Drug: Placebo for Elsubrutinib Drug: Upadacitinib Drug: Placebo for Upadacitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||July 27, 2020|
|Estimated Primary Completion Date :||December 28, 2023|
|Estimated Study Completion Date :||December 28, 2023|
Experimental: Part 1: Elsubrutinib Dose A and Upadacitinib Dose A
Participants will receive Elsubrutinib Dose A and Upadacitinib Dose A once daily (QD).
Other Name: ABBV-105
Experimental: Part 2: Elsubrutinib Dose A and Upadacitinib Dose B
Participants will receive Elsubrutinib Dose A and Upadacitinib Dose B QD.
Other Name: ABBV-105
Experimental: Part 3: Elsubrutinib Dose A and Upadacitinib Placebo
Participants will receive Elsubrutinib Dose A and Upadacitinib placebo QD.
Other Name: ABBV-105
Drug: Placebo for Upadacitinib
Experimental: Part 4: Elsubrutinib Placebo and Upadacitinib Dose A
Participants will receive Elsubrutinib placebo and Upadacitinib Dose A QD.
Drug: Placebo for Elsubrutinib
- Number of Participants With Adverse Events [ Time Frame: Through Week 108 ]An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
- Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 [ Time Frame: Through Week 104 ]SRI is a composite responder index based on improvement in disease activity without worsening of the overall condition or the development of significant disease activity in new organ systems.
- Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) [ Time Frame: Through Week 104 ]BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.
- Change in Steroid Burden [ Time Frame: Baseline of M19-130 (Week 0) Through Week 104 ]Steroid Burden is measured as milligrams (mg) of prednisone-equivalent administered.
- Number of Flares Per Patient-Year (Respectively and Overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) flare index (SFI) [ Time Frame: Through Week 104 ]SELENA SLEDAI flare index defines (mild, moderate or severe) SLE flares using the SLEDAI-2K score, disease activity scenarios, treatment changes, and Physician's Global Assessment of Disease Activity.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451772
|Study Director:||ABBVIE INC.||AbbVie|
|Other Study ID Numbers:||
2020-001690-72 ( EudraCT Number )
|First Posted:||June 30, 2020 Key Record Dates|
|Last Update Posted:||January 18, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/|
|Access Criteria:||Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action