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

Trial Details

Brief Summary: The main objective of this study is to evaluate the safety and efficacy of ABBV-105, upadacitinib, and ABBV-599 vs placebo for the treatment of signs and symptoms of SLE in participants with moderately to severely active SLE and to define doses for further development.

Condition or disease
Systemic Lupus Erythematosus (SLE)

Intervention/treatment
Drug: ABBV-105
Drug: Upadacitinib

Phase
Phase 2

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 prior to 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).

  • The combination of background treatment with antimalarial(s) and/or prednisone (or equivalent) is permitted

  • And a single, but not multiple, additional immunosuppressant from the list above, 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.

*Other protocol-defined inclusion/exclusion criteria may apply

View Trial on ClinicalTrials.gov website: NCT03978520