Clinical trial NCT02349451: 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)
Official title: A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response to Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Safety
Efficacy
Methotrexate
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo
timeFrame: Week 12
Secondary outcomes:
measure: ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab
timeFrame: Week 12
measure: ACR50 Response Rate at Week 12
timeFrame: Week 12
measure: ACR70 Response Rate at Week 12
timeFrame: Week 12
measure: ACRn at Week 12
timeFrame: At Week 12
measure: Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Psoriasis Target Lesion Score at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Paul Peloso, MD
role: STUDY_DIRECTOR
References:
citation: Khatri A, Klunder B, Peloso PM, Othman AA. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):352-360. doi: 10.1093/rheumatology/key312.
citation: Mease PJ, Genovese MC, Weinblatt ME, Peloso PM, Chen K, Othman AA, Li Y, Mansikka HT, Khatri A, Wishart N, Liu J. Phase II Study of ABT-122, a Tumor Necrosis Factor- and Interleukin-17A-Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2018 Nov;70(11):1778-1789. doi: 10.1002/art.40579.