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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) (SLEek)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03978520
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : December 23, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
The main objective of this study is to evaluate the safety and efficacy of elsubrutinib, upadacitinib, and ABBV-599 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.

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
Actual Study Start Date : July 25, 2019
Actual Primary Completion Date : January 19, 2022
Actual Study Completion Date : July 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: Upadacitinib and Elsubrutinib
Participants will be administered with elsubrutinib dose A and upadacitinib dose A.
 Drug: Elsubrutinib
Capsule; Oral
Other Name: ABBV-105

Drug: Upadacitinib
Tablet; Oral
Other Name: RINVOQ
Experimental: Group 2: Upadacitinib and Elsubrutinib
Participants will be administered with elsubrutinib dose A and upadacitinib dose B.
 Drug: Elsubrutinib
Capsule; Oral
Other Name: ABBV-105

Drug: Upadacitinib
Tablet; Oral
Other Name: RINVOQ
Experimental: Group 3: Elsubrutinib and Placebo for Updadacitinib
Participants will be administered with elsubrutinib dose A and placebo for upadacitinib.
 Drug: Elsubrutinib
Capsule; Oral
Other Name: ABBV-105

Drug: Placebo for upadacitinib
Tablet; Oral
Experimental: Group 4: Upadacitinib and Placebo for Elsubrutinib
Participants will be administered with placebo for elsubrutinib and upadacitinib dose A.
 Drug: Placebo for Elsubrutinib
Capsule; Oral

Drug: Upadacitinib
Tablet; Oral
Other Name: RINVOQ
Experimental: Group 5: Placebo for Elsubrutinib and Placebo for Upadacitinib
Participants will be administered with placebo for elsubrutinib and placebo for upadacitinib.
 Drug: Placebo for Elsubrutinib
Capsule; Oral

Drug: Placebo for upadacitinib
Tablet; Oral


Outcome Measures
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Primary Outcome Measures :
  1. Achievement of SLE Responder Index (SRI)-4 and steroid dose <= 10 mg prednisone equivalent once a day (QD) [ Time Frame: Week 24 ]
    SRI-4 is defined as >= 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score without worsening of the overall condition (no worsening in Physician's Global Assessment (PhGA), < 0.3 point increase) or the development of significant disease activity in new organ systems (no new British Isles Lupus Assessment Group [BILAG] A or > 1 new BILAG B).


Secondary Outcome Measures :
  1. Achievement of SRI-4 [ Time Frame: Up to Week 24 ]
    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.

  2. Achievement of British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) [ Time Frame: Up to Week 24 ]
    BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.

  3. Achievement of Lupus Low Disease Activity State (LLDAS) [ Time Frame: Up to Week 24 ]
    LLDAS is a state of low disease activity based on SLEDAI score, absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment, and concomitant medication usage.

  4. Change in Steroid Burden from Baseline [ Time Frame: From Baseline (Week 0) to Week 24 ]
    Steroid Burden is measured as milligrams (mg) of daily prednisolone administered.

  5. Number of flares by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI flare index [ Time Frame: Up to Week 24 ]
    SELENA SLEDAI flare index defines SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has clinical diagnosis of 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 >= 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 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, at 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.

Exclusion Criteria:

- 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.

Contacts and Locations
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Information from the National Library of Medicine

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): NCT03978520


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03978520    
Other Study ID Numbers: M19-130
2019-000638-20 ( EudraCT Number )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: December 23, 2022
Last Verified: December 2022
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.
Supporting Materials: Study Protocol
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/
URL: https://vivli.org/ourmember/abbvie/

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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.: No
Keywords provided by AbbVie:
Systemic Lupus Erythematosus (SLE)
ABBV-105
Upadacitinib
ABBV-599
Elsubrutinib
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Upadacitinib
 Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents