A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 16
- 主要终点
- Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.
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
- •Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline.
- •Have moderate-to-severe psoriasis in the genital area at screening and baseline.
- •Have plaque psoriasis in a nongenital area at screening and baseline.
- •Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area.
- •Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug.
排除标准
- •Pustular, erythrodermic, and/or guttate forms of psoriasis.
- •History of drug-induced psoriasis.
- •Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments).
- •Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action.
- •Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study.
- •Are currently enrolled in any other clinical trial involving an investigational product.
- •Serious disorder or illness other than plaque psoriasis.
- •Active or history of malignant disease within 5 years prior to baseline.
- •Serious infection within the last 3 months.
- •Have received a live vaccine within 3 months of baseline or plan to do so during the study.
- •Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.
- •Pregnant or breastfeeding (lactating) women.
研究组 & 干预措施
Ixekizumab
Blinded Treatment Period: 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab every 2 weeks (Q2W) SC from week 2 to week 10. At week 12, 80 mg ixekizumab and placebo given SC.
Open Label Period: 80 mg ixekizumab given SC every 4 weeks (Q4W) with an option for Q2W dosing starting at week 24, week 28 or week 40.
干预措施: Ixekizumab (Drug)
Ixekizumab
Blinded Treatment Period: 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab every 2 weeks (Q2W) SC from week 2 to week 10. At week 12, 80 mg ixekizumab and placebo given SC.
Open Label Period: 80 mg ixekizumab given SC every 4 weeks (Q4W) with an option for Q2W dosing starting at week 24, week 28 or week 40.
干预措施: Placebo (Drug)
Placebo
Blinded Treatment Period: Placebo given SC at baseline followed by placebo given SC Q2W from week 2 to week 10. At week 12, 160 mg ixekizumab given SC.
Open Label Period: 80 mg ixekizumab given SC Q4W with an option for Q2W dosing starting at week 24, week 28 or week 40.
干预措施: Ixekizumab (Drug)
Placebo
Blinded Treatment Period: Placebo given SC at baseline followed by placebo given SC Q2W from week 2 to week 10. At week 12, 160 mg ixekizumab given SC.
Open Label Period: 80 mg ixekizumab given SC Q4W with an option for Q2W dosing starting at week 24, week 28 or week 40.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
时间窗: Week 12
sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.
次要结局
- Number of Participants Achieving Overall sPGA (0,1)(Week 12)
- Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS)(Week 12)
- Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2(Week 12)
- Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)(Week 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score(Baseline, Week 12)
- Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)(Week 12)
- Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)(Baseline, Week 12)
- Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)(Baseline, Week 12)
- Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items(Baseline, Week 12)
- Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status(Week 12)
- Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score(Baseline, Week 12)