A Phase 3, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of CNTO1959 (Guselkumab) in the Treatment of Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Percentage of Participants with Treatment Success at Week16
研究概览
简要总结
The purpose of this study is to examine descriptively the efficacy of CNTO 1959 in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).
详细描述
This is a phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), open-label study evaluating the efficacy and safety of CNTO1959 (Guselkumab) in the treatment of participants with GPP or EP. Participants will receive 50 milligram (mg) guselkumab subcutaneously at Weeks 0, 4 and 12. At Week 16 up to Week 52 participants who will be defined "Very much improved" or "Much improved" in Clinical Global Impression (CGI) will continue to receive guselkumab 50 mg every 8 weeks from Week 20 to the study end (Week 52). At each visit timing from Week 20, participants who will be defined "No change" or "Worsened" will receive guselkumab 100 mg and continue 100 mg every 8 weeks dosing until Week 52. Participants who are "Minimally improved" will also receive guselkumab 100 mg only if investigator considers it necessary. Participants will primarily be assessed for the treatment success. Participants' safety will be monitored throughout the study.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) at screening. A diagnosis of GPP must be classified on the basis of the criteria for diagnosis of GPP by Japanese Dermatological Association (JDA)
- •Have a history of plaque-type psoriasis if subjects have a diagnosis of EP
- •Have an involved body surface area (BSA) of lesion greater than or equal to (>=) 80 percent (%) at baseline if subjects have a diagnosis of EP.
- •Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
- •Before the first administration of study drug, a woman must be either not of childbearing potential or of childbearing potential and practicing a highly effective methods of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies
排除标准
- •Has a total score of JDA severity index for GPP >=14 at baseline if subjects have a diagnosis of GPP
- •Has a differential diagnosis of the erythroderma (exmaple (eg), erythroderma caused by lymphoma or drug eruption) other than EP.
- •Has refused hospitalization though the investigator needed hospitalization
- •Has body mass index (BMI) less than (<) 18 kilogram per square meters (kg/m^2) or meets the following modified criteria for cachexia.
- •Has a BMI < 20 kg/m^2 and has lost more than 5% of their body weight in the previous months, and 4 out of the following are present: a) decreased muscle strength b) fatigue or reduced physical activity c) anorexia d) low muscle mass e) CRP greater than (>) 7 mg/L 6) hemoglobin (Hb) <12 gram per deciliters (g/dL) f) serum albumin < 3.0 g/dL
- •Has Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Grade 2 or higher heart failure or CTCAE v.4 Grade 3 or higher kidney failure
研究组 & 干预措施
Guselkumab
Participants will receive 50 milligram (mg) guselkumab subcutaneously at Weeks 0, 4 and 12. At Week 16 through the study end (Week 52) participants who are defined "Very much improved" or "Much improved" in Clinical Global Impression (CGI) will continue to receive guselkumab 50 mg every 8 weeks from Week 20 to the study end (Week 52). At each visit timing from Week 20, participants who are defined "No change" or "Worsened" in CGI will receive guselkumab 100 mg and continue 100 mg every 8 weeks dosing until the study end (Week 52). Participants who are defined "Minimally improved" in CGI will also receive guselkumab 100 mg only if the investigator considers that it is necessary.
干预措施: Guselkumab (Drug)
结局指标
主要结局
Percentage of Participants with Treatment Success at Week16
时间窗: Week 16
Treatment success is defined as "Very much improved", "Much improved" or "Minimally improved" in Clinical Global Impression (CGI) scale. The CGI scale is a brief clinician-rated instrument which has five categories (Very much improved (1), Much improved (2), Minimally improved (3), No change (4), Worsened (5).
次要结局
- Number of Participants With Guselkumab Antibodies(Baseline, Pre-dose on Week 4, 16, 28, 48 and 52)
- Change From Baseline in Body Surface Area (BSA) of Involvement of Lesion for Erythrodermic Psoriasis (EP) Over Time(Baseline, Week 1, 2, 4, 6, 8, 16, 28, 36, 48 and 52)
- Observed Serum Guselkumab Concentrations(Baseline, Pre-dose on Week 4, 8, 12, 16, 20, 24, 28, 36, 44, 48 and 52)
- Percentage of Participants With Investigator's global assessment (IGA) score of 0 or 1 at Week 16 and over time(Week 16, 28, 36, 48 and 52)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 and Over Time(Baseline, Week 16, 28, 36, 48 and 52)
- Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 and over time(Week 16, 28, 36, 48 and 52)
- Change From Baseline in Total and Component Japanese Dermatological Association (JDA) Severity Index for Generalized Pustular Psoriasis (GPP) Over Time(Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52)
- Change From Baseline in Physical and Mental Component Summary Scores of SF-36 Over Time(Baseline, Week 16, 28, 36 and 48)
- Percentage of Participants with Treatment Success Over Time(Baseline and Every 4 weeks up to Week 52)
- Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP Over Time(Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52)
- Percentage of Participants With a Reduction of 5 or More Points in DLQI Score Over Time(Baseline, Week 8, 16, 28, 36, 48 and 52)
- Change From Baseline in Components of the JDA Severity Index for GPP Over Time(Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 48 and 52)
- Percentage of Participants with DLQI Score of 0 or 1 Over Time in Participants With Baseline DLQI More Than 1(Baseline, Week 8, 16, 28, 36, 48 and 52)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Psoriasis (PSO) Over Time(Baseline, Week 16, 28, 36 and 48)