2023-506026-36-00招募中3 期
Open-label, randomized, assessor-blinded, efficacy, safety, tolerability, and pharmacokinetics study of subcutaneous risankizumab with an adalimumab reference arm in children with active juvenile psoriatic arthritis
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 12
- 主要终点
- The primary endpoint is the achievement of JIA-ACR 30 response at Week 24.
研究概览
简要总结
The primary study objective is to assess efficacy, safety, tolerability, and PK of risankizumab with an adalimumab reference arm in children and adolescent subjects age 5 to < 18 years with active jPsA who have had an inadequate response to, or are intolerant of, methotrexate (MTX) or other csDMARDs.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a diagnosis of jPsA according to ILAR criteria for at least 6 months prior to Screening.
- •Active disease in ≥ 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both). Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, limitation of motion with pain or tenderness or both meet the criteria for an active arthritic joint.
- •Subject must have demonstrated an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose), or intolerance to previous or current treatment with at least 1 of the following csDMARDs: MTX, sulfasalazine, leflunomide, or hydroxychloroquine.
排除标准
- •Subjects have any other autoimmune disease, rheumatic disease (including systemic JIA, rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome.
结局指标
主要结局
The primary endpoint is the achievement of JIA-ACR 30 response at Week 24.
The primary endpoint is the achievement of JIA-ACR 30 response at Week 24.
次要结局
- In subjects with PsO (at least 3% BSA at Baseline), achievement of PASI 75/90 at Week 24
- In subjects with PsO (at least 3% BSA at Baseline), achievement of the sPGA of PsO of 'clear' or 'almost clear' (0/1) at Week 24.
- Achievement of JIA-ACR 50/70/90 response at Week 24
- Percent change from Baseline in individual components of JIA-CRV at Week 24.
- Change from Baseline in JADAS-10 and JADAS-27 at Week 24.
- Achievement of MDA at Week 24 (defined as JADAS-10 of ≤6)
- Achievement of inactive disease at Week 24 (defined as JADAS-10 of ≤2.7)
- Change from Baseline in cJADAS-10 and cJADAS-27 at Week 24.
- Change from Baseline in the Pain-VAS at Week 24
- In subjects with PsO (at least 3% BSA at Baseline), change from Baseline in CDLQI at Week 24.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (12)
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