A Phase 4 Multicenter, Randomized, Double-Blind Study of Risankizumab for the Treatment of Adult Subjects With Moderate to Severe Genital Psoriasis or Moderate to Severe Scalp Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 72
- 主要终点
- Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1 at Week 16
研究概览
简要总结
Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored.
Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally.
The study will be broken up into 2 studies by disease location, participants with moderate to severe genital psoriasis (Study-G) and moderate to severe scalp psoriasis (Study-S). In both studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
详细描述
Safety and efficacy data through 22 January 2025 are included in the interim analysis, which was conducted after all participants completed Week 16 of Study-G or Study-S in Period A.
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
- Double (Participant, Investigator)
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
- •Must have clinical diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the baseline visit.
- •Must have a current diagnosis of moderate to severe genital psoriasis (Study-G) defined as static Physician Global Assessment of Genitalia (sPGA-G) ≥ 3 or moderate to severe scalp psoriasis (Study-S) defined as Psoriasis Scalp Severity Index (PSSI) >= 12, scalp Investigator Global Assessment (IGA) >= 3, and >= 30% of the scalp affected.
- •Must have body surface area (BSA) ≥ 1% with at least 60% of subjects having BSA ≥ 10%; sPGA ≥ 3; inadequate control of psoriasis and/or intolerance to topical treatment, phototherapy and/or systemic therapy; and be candidates for systemic therapy or phototherapy as assessed by the investigator.
排除标准
- •Had previous exposure to IL-23 inhibitors including but not limited to guselkumab, tildrakizumab, ustekinumab, mirikizumab, or risankizumab.
- •History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- •Non-plaque forms of psoriasis or other active skin disease.
研究组 & 干预措施
Study-G Placebo/Risankizumab (Period B)
Participants with moderate to severe genital psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.
干预措施: Risankizumab (Drug)
Study-G Placebo (Period A)
Participants with moderate to severe genital psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.
干预措施: Placebo for Risankizumab (Drug)
Study-G Risankizumab (Period A)
Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.
干预措施: Risankizumab (Drug)
Study-S Placebo (Period A)
Participants with moderate to severe scalp psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.
干预措施: Placebo for Risankizumab (Drug)
Study-S Risankizumab (Period A)
Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.
干预措施: Risankizumab (Drug)
Study-G Risankizumab/Risankizumab (Period B)
Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.
干预措施: Risankizumab (Drug)
Study-S Placebo/Risankizumab (Period B)
Participants with moderate to severe scalp psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.
干预措施: Risankizumab (Drug)
Study-S Risankizumab/Risankizumab (Period B)
Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.
干预措施: Risankizumab (Drug)
结局指标
主要结局
Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1 at Week 16
时间窗: Week 16
The sPGA-G is a 6-point score ranging from 0 to 5, with a higher score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.
Study-S: Percentage of Participants With Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1 at Week 16
时间窗: Week 16
The scalp IGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The scalp IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. Higher scores indicate more severe disease.
次要结局
- Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 at Week 16(Week 16)
- Study-G: Percentage of Participants With Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16(Week 16)
- Study-G: Percentage of Participants With Achievement of Clinically Meaningful (≥ 4-point) Improvement From Baseline on the Genital Psoriasis Itch Numerical Rating Scale (NRS) at Week 16 [Among Participants With a Baseline Score ≥ 4](Baseline, Week 16)
- Study-G: Percentage of Participants With Achievement of Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 [Among Participants With a Baseline Score ≥ 2](Baseline, Week 16)
- Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16(Baseline, Week 16)
- Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index 75 (PSSI 75) at Week 16(Baseline, Week 16)
- Study-S: Change From Baseline in Psoriasis Symptom Scale (PSS) at Week 16(Baseline, Week 16)
- Study-S: Percentage of Participants With Achievement of Psoriasis Scalp Severity Index (PSSI 100) at Week 16(Baseline, Week 16)
- Study-S: Percentage of Participants With Achievement of Psoriasis Symptom Scale (PSS) of 0 at Week 16(Week 16)