A Phase 2b Multicenter, Long-Term Extension, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 119
- 主要终点
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 36
研究概览
简要总结
The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.
详细描述
The populations of people living with moderate to severe psoriasis is approximately 3.5 billion which are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. This is a long-term extension study of JNJ-77242113 in eligible participants who have completed the Week 16 visit of the originating Study 77242113PSO2001. The total duration of this study will be up to 40 weeks which will include a 36-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 completed the Week 16 visit in Protocol 77242113PSO2001
- •In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study
- •Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study
- •Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention
- •Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention
排除标准
- •Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason
- •Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001
- •Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention
- •Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention
- •Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV
研究组 & 干预措施
Group 2: JNJ-77242113 Dose 2 QD
Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.
干预措施: JNJ-77242113 (Drug)
Group 3: JNJ-77242113 Dose 3 QD
Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.
干预措施: JNJ-77242113 (Drug)
Group 1: JNJ-77242113 Dose 1 Once Daily (QD)
Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.
干预措施: JNJ-77242113 (Drug)
Group 6: JNJ-77242113 Dose 3 QD
Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.
干预措施: JNJ-77242113 (Drug)
Group 4: JNJ-77242113 Dose 1 Twice Daily (BID)
Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.
干预措施: JNJ-77242113 (Drug)
Group 5: JNJ-77242113 Dose 3 BID
Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.
干预措施: JNJ-77242113 (Drug)
结局指标
主要结局
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 36
时间窗: Week 36
Percentage of participants achieving PASI 75 score (greater than or equal to \[\>=\] 75 percent \[%\] improvement in PASI from baseline of the originating study \[77242113PSO2001\]) at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
次要结局
- Change From Baseline in PASI Total Score at Week 36(Baseline and Week 36)
- Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 36(Week 36)
- Percentage of Participants Achieving PASI 100 Score at Week 36(Week 36)
- Change from Baseline in PSSD Signs Score at Week 36(Baseline and Week 36)
- Number of Participants with Serious Adverse Events (SAEs)(Up to Week 40)
- Percentage of Participants Achieving PASI 90 Score at Week 36(Week 36)
- Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Signs Score >=1(Week 36)
- Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 36(Baseline and Week 36)
- Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Symptoms Score >=1(Week 36)
- Number of Participants with Adverse Events (AEs)(Up to Week 40)