A Phase 3b, Multicenter, Interventional, Open-label Study of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Have a Suboptimal Response to Secukinumab or Ixekizumab and Are Switched to Risankizumab
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 57
- 主要终点
- Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
研究概览
简要总结
This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms.
Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0).
- •Participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of Screening and Baseline visits.
- •Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global Assessment (sPGA) 2/3
- •Participant must be eligible for continued biologic therapy as assessed by the investigator.
排除标准
- •History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis.
- •Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis.
- •History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
- •History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator.
- •Participant with exposure to risankizumab or any IL-23 inhibitors.
研究组 & 干预措施
Risankizumab
Participants receive Risankizumab following suboptimal response to secukinumab or ixekizumab
干预措施: Risankizumab (Drug)
结局指标
主要结局
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
时间窗: At Week 16
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
次要结局
- Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1(At Week 52)
- Time to Achieve sPGA 0/1(Up to Week 52)
- Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1(At Week 52)
- Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)(At Week 52)
- Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0(At Week 16)
- Proportion of Participants Achieving a PSS 0(At Week 52)
- Time to Achieve sPGA 0(Up to Week 52)