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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 主要终点
- American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •>= 3 swollen joints (based on 66 joint counts) at Screening
- •>= 3 tender joints (based on 68 joint counts) at Screening
- •On a stable dose of methotrexate (MTX) defined as:
- •Oral or parenteral treatment >= 3 months
- •On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline
- •Stable MTX dose of >= 10 mg/week and <= the upper limit of the applicable approved local label
- •Can also be on stable doses of nonsteroidal anti-inflammatory drugs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate
排除标准
- •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:
- •Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females
- •Absolute neutrophil count (ANC) < 1500 mm^3, (or < 1200 cells/µL for subjects of African descent who are black)
- •Aspartate aminotransferase or alanine aminotransferase > 1.5 x the upper limit of normal (ULN) or bilirubin >= 3 mg/dL
- •Serum creatinine > 1.5 x the ULN
- •Platelets < 100,000 cells/[mm^3] (10^9/L),
- •Clinically significant abnormal screening laboratory results as evaluated by the Investigator
研究组 & 干预措施
Placebo
Double-blind placebo administered every week (EW) for 12 weeks
干预措施: ABT-122 (Biological)
Adalimumab
Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks
干预措施: adalimumab (Biological)
ABT-122 120 mg
Double-blind ABT-122 120 mg administered EW for 12 weeks
干预措施: ABT-122 (Biological)
ABT-122 240 mg
Double-blind ABT-122 240 mg administered EW for 12 weeks
干预措施: ABT-122 (Biological)
结局指标
主要结局
American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo
时间窗: Week 12
Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein \[hsCRP\]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
次要结局
- ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab(Week 12)
- ACR50 Response Rate at Week 12(Week 12)
- ACR70 Response Rate at Week 12(Week 12)
- ACRn at Week 12(At Week 12)
- Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12(Baseline, Week 12)
- Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12(Baseline, Week 12)
- Change From Baseline in Psoriasis Target Lesion Score at Week 12(Baseline, Week 12)