phase 2 study to evaluate safety and efficacy of ABBV-105 and ABBV-599 (ABBV-105 plus upadacitinib) 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.
Criteria:• Adult male or female, at least 18 years old.
• Diagnosis of RA for ≥ 3 months based on the 2010 ACR/EULAR classification criteria for RA.
• Subject 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; and
○ hsCRP ≥ 3 mg/L (central lab) at Screening Visit.
• Subjects must have been treated for ≥ 3 months with ≥ 1 bDMARD therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration.
• Subjects must have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug.
○ The following csDMARDs are allowed (stable dose for
≥ 4 weeks prior to the first dose of study drug): oral or
parenteral methotrexate (MTX) (7.5 to 25 mg/week),
sulfasalazine (≤ 3000 mg/day), hydroxychloroquine (≤ 400
mg/day), chloroquine (≤ 250 mg/day), and leflunomide (≤ 20
mg/day).
○ A combination of up to two background csDMARDs is allowed
EXCEPT the combination of MTX and leflunomide.