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)

AbbVie

Status and phase: Completed; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Biological: adalimumab; Biological: ABT-122

Study type: Interventional

Funder types: Industry

Identifiers

NCT02349451

2014-003558-15 (EudraCT Number)

M14-197

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 4 patient groups, including a placebo group

Adalimumab

Active Comparator group

Description:

Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks

Treatment:

Biological: adalimumab

Placebo

Placebo Comparator group

Description:

Double-blind placebo administered every week (EW) for 12 weeks

Treatment:

Biological: ABT-122

ABT-122 120 mg

Experimental group

Description:

Double-blind ABT-122 120 mg administered EW for 12 weeks

Treatment:

Biological: ABT-122

ABT-122 240 mg

Experimental group

Description:

Double-blind ABT-122 240 mg administered EW for 12 weeks

Treatment:

Biological: ABT-122