A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Elsubrutinib; Upadacitinib; Placebo for elsubrutinib; Placebo for upadacitinib
Intervention description: Elsubrutinib capsule will be administered orally.; Upadacitinib tablet will be administered orally.; Placebo capsule for elsubrutinib will be administered orally.; Placebo tablet for upadacitinib will be administered orally.
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Elsubrutinib; ABBV-105; Upadacitinib; ABBV-599; Rheumatoid Arthritis

Summary:

      This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and
      ABBV-599 (ELS plus upadacitinib [UPA]) vs placebo on a background of conventional synthetic
      disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of
      rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs
      (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to
      severely active RA and to define optimal dose for further development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months based on the 2010 American
             College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification
             criteria for RA

          -  Participant meets the following minimum disease activity criteria:

               -  ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68
                  joint counts) at Screening and Baseline Visits

               -  High-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L (central lab) at Screening
                  Visit

          -  Participants must have been treated for ≥ 3 months with ≥ 1 biologic disease-modifying
             anti-rheumatic drug (bDMARD) therapy but continue to exhibit active RA or had to
             discontinue due to intolerability or toxicity, irrespective of treatment duration

          -  Participants must have been receiving conventional synthetic disease-modifying
             anti-rheumatic drug (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks
             prior to the first dose of study drug

          -  Participants must have discontinued all bDMARDs prior to the first dose of study drug

        Exclusion Criteria:

        - Participant has prior exposure to any Janus Kinase (JAK) inhibitor for greater than 2
        weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and
        filgotinib). A washout period of ≥ 30 days is required for any JAK inhibitor prior to the
        first dose of study drug.