Last updated on August 2019

A Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: Between 18 - 65 Years
  • Gender: Male or Female

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 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.
  • Physician's Global Assessment (PhGA) >= 1 during screening period
  • Background treatment, stable for 30 days, at Baseline with prednisone, antimalarials, azathioprine, mycophenolate, leflunomide cyclosporine, tacrolimus, and/or methotrexate (MTX).
  • The combination of background treatment with antimalarial(s) and/or prednisone (or equivalent) and a single, but not multiple, additional immunosuppressant is permitted.

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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