A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
This study is a Phase 2 randomized, double-blind, double-dummy, active- and
 placebo-controlled, parallel-group study designed to assess the safety, tolerability,
 efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants
 with active PsA who are inadequately responding to MTX treatment.
Inclusion Criteria:

 -  PsA diagnosis of at least 3 months duration prior to the date of first screening with
 ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.

 -  Have active psoriasis defined by at least 1 psoriasis lesion >= 2 cm diameter in areas
 other than the axilla or groin.

 -  Have active arthritis defined by minimum disease activity criteria:

 1. >= 3 swollen joints (based on 66 joint counts) at Screening

 2. >= 3 tender joints (based on 68 joint counts) at Screening

 -  On a stable dose of methotrexate (MTX) defined as:

 1. Oral or parenteral treatment >= 3 months

 2. On a stable dose with an unchanged mode of application for at least 4 weeks prior
 to baseline

 3. Stable MTX dose of >= 10 mg/week and <= the upper limit of the applicable
 approved local label

 4. Can also be on stable doses of nonsteroidal anti-inflammatory drugs,
 sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate

 Exclusion Criteria:

 -  Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be
 enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or safety
 concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior
 to the Baseline visit.

 -  Subjects on prior adalimumab may not be enrolled in the study

 -  Prior exposure to other non-TNF inhibitor biological disease-modifying antirheumatic
 drugs (DMARDs) will be permitted if the subject is washed out at least 5 half-lives of
 these drugs prior to the baseline visit.

 -  Current treatment with traditional oral/intramuscular DMARDs, including conventional
 synthetic DMARDs (csDMARDs; except for concomitant treatment with sulfasalazine and/or
 hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5
 half-lives of a drug apart from MTX prior to the Baseline visit.

 a. Subject could have been exposed to prior Janus kinase (JAK) or phosphodiesterase
 type 4 (PDE4) inhibitors so long as they have been off therapy for at least 5
 half-lives.

 -  Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within
 the 30 days of the Baseline visit.

 -  Intra-articular or parenteral administration of corticosteroids in the preceding 4
 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are
 allowed.

 -  Laboratory values of the following at the Screening Visit:

 1. Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females

 2. Absolute neutrophil count (ANC) < 1500 mm^3, (or < 1200 cells/µL for subjects of
 African descent who are black)

 3. Aspartate aminotransferase or alanine aminotransferase > 1.5 x the upper limit of
 normal (ULN) or bilirubin >= 3 mg/dL

 4. Serum creatinine > 1.5 x the ULN

 5. Platelets < 100,000 cells/[mm^3] (10^9/L),

 6. Clinically significant abnormal screening laboratory results as evaluated by the
 Investigator