A Phase 3, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
概览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 24
- 主要终点
- Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at Week 16
概览
简要总结
The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study participant has a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) at screening. For GPP, a diagnosis must be classified based on the criteria for diagnosis of GPP by the Japanese Dermatological Association (JDA); for EP, has a history of plaque-type psoriasis. In addition, has an involved body surface area (BSA) of lesion greater than or equal to (\>=) 80 percent (%) at baseline
- •Candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)
- •A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and have a negative urine pregnancy test at Week 0 prior to administration of study intervention
- •A male participant must agree not to plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention
- •A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention
排除标准
- •The study participant has a total score of JDA severity index for GPP \>=14 at baseline if participants have a diagnosis of GPP
- •The study participant has a differential diagnosis of the erythroderma (for example, erythroderma caused by lymphoma or drug eruption) other than EP
- •The study participant has a history of or current diagnosis or signs or symptoms of severe, progressive, or uncontrolled liver, renal; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •The study participant has a history of amyloidosis
- •Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
- •The study participant who doesn't meet the criteria of prior/current concomitant therapy and/or history/conditions of infections
研究组 & 干预措施
JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP)
Participants with GPP or EP will receive JNJ-77242113 tablet orally.
干预措施: JNJ-77242113 (Drug)
结局指标
主要结局
Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at Week 16
时间窗: Week 16
Percentage of participants with GPP who experienced treatment success at Week 16 was reported. Treatment success for GPP was defined as at least "minimally improved" rating in Clinical Global Impression (CGI) scale for GPP based on Japanese Dermatological Association (JDA) total score. JDA severity index includes skin symptoms (area of erythema with pustules, total area of erythema, and area of edema; each scored 0-3) and systemic/laboratory findings (fever, white blood cell count, C-reactive protein, and serum albumin; each scored 0-2). JDA total score was sum of 2 assessments ranging from 0 (best) to 17 (worst). CGI ratings were defined as: 1=Very much improved (greater than or equal to \[\>=\]3-point reduction in JDA total score), 2=Much improved (1-2-point reduction), 3=Minimally improved (no change in JDA total score, but \>=20 percent (%) reduction in area of erythema with pustules or meaningful improvement in \>=1 other parameter), 4=No change, 5=Worsened. Higher score = worsening.
Percentage of Participants With Erythrodermic Psoriasis (EP) Who Experience Treatment Success at Week 16
时间窗: Week 16
Percentage of participants with EP who experienced treatment success at Week 16 was reported. Treatment success for EP was defined as at least "minimally improved" rating in CGI scale for EP. The CGI scale is a clinician-rated 5-point scale with the following categories: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Worsened. Higher score indicated worsening.
次要结局
- Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) Over Time(Baseline (Week 0) up to Week 156)
- Percentage of Participants Who Achieved an IGA Score of Cleared (0) Over Time(Baseline (Week 0) up to Week 156)
- Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Over Time(From baseline (Week 0) up to Week 156)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time(From baseline (Week 0) up to Week 156)
- Percentage of Participants Who Achieved DLQI Score of 0 or 1 Over Time(Baseline (Week 0) up to Week 156)
- Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L) Over Time: Domain Scores(From baseline (week 0) up to Week 156)
- Change From Baseline in EQ-5D-5L Over Time: Visual Analog Scale (VAS) Scores(From baseline (Week 0) up to Week 156)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(Baseline (Week 0) up to 160 weeks)
- Change From Baseline in the Body Surface Area (BSA) of Involvement of Lesion for EP Over Time(From baseline (Week 0) up to Week 156)
- Percentage of Participants With GPP Who Experienced Treatment Success Over Time Based on CGI Scale According to JDA Total Score(From baseline (Week 0) to Week 156)
- Percentage of Participants With EP Who Experienced Treatment Success Over Time Based on CGI Scale(From Baseline (Week 0) to Week 156)
- Change From Baseline in the Total Score of the Japanese Dermatological Association (JDA) Severity Index for GPP Over Time(From baseline (Week 0) up to Week 156)
- Change From Baseline in Severity Classification of JDA Severity Index for GPP Over Time(From baseline (Week 0) up to Week 156)