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

Study Identifier
M20-186
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Japanese, Chinese (Taiwan), Hungarian, Spanish (Argentina), Spanish (Mexico)

Study Details

Medical Condition
  • Lupus (Systemic Lupus Erythematosus (SLE))
  • Study Drug
  • Elsubrutinib
  • Placebo for Elsubrutinib
  • Upadacitinib
  • Placebo for Upadacitinib
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 227833
    Phoenix, Arizona, United States, 85032-9306
    Status
    Not applicable
    Location
    Wallace Rheumatic Studies Center, LLC /ID# 224374
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Valerius Medical Group & Research Center /ID# 223922
    Los Alamitos, California, United States, 90720-5402
    Status
    Not applicable
    Location
    East Bay Rheumatology Medical /ID# 225493
    San Leandro, California, United States, 94578
    Status
    Not applicable
    Location
    University of Colorado Hospital /ID# 245087
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 227828
    Aventura, Florida, United States, 33180
    Status
    Not applicable
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