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)

• Status: Active, not recruiting
• Trial end date: 2022-08-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Upadacitinib

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.