A Phase 2b Multicenter, Randomized, Placebo Controlled, 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
- 255
- 试验地点
- 145
- 主要终点
- Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16
研究概览
简要总结
Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 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 psoriatic arthritis (PsA) and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. 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
- 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
- •Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 6 months prior to the first administration of study intervention
- •Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis
- •Participant has a total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
- •Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline
- •Participant has a total Investigator global assessment (IGA) >=3 at screening and baseline
排除标准
- •Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- •Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •Participant have previously received any other therapeutic agent directly targeted to interleukin 23 receptor (IL-23R) (including but not limited to guselkumab, tildrakizumab, or risankizumab)
- •Participant has received any therapeutic agent directly targeted to interleukin 17 receptor (IL-17) or interleukin 12/23 receptor (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received anti-tumor necrosis factor [TNF]-alpha biologic therapy (including, but not limited to adalimumab) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
- •Participant has received agents that deplete B cells (including, but not limited to, rituximab, or alemtuzumab) within 26 weeks of the first administration of study intervention
研究组 & 干预措施
Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo
Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: JNJ-77242113 (Drug)
Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo
Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: Placebo (Drug)
Group 2: JNJ-77242113 Dose 2 QD and Placebo
Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: JNJ-77242113 (Drug)
Group 2: JNJ-77242113 Dose 2 QD and Placebo
Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: Placebo (Drug)
Group 3: JNJ-77242113 Dose 3 QD and Placebo
Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: JNJ-77242113 (Drug)
Group 3: JNJ-77242113 Dose 3 QD and Placebo
Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: Placebo (Drug)
Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo
Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: JNJ-77242113 (Drug)
Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo
Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: Placebo (Drug)
Group 5: JNJ-77242113 Dose 3 BID and Placebo
Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: JNJ-77242113 (Drug)
Group 5: JNJ-77242113 Dose 3 BID and Placebo
Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
干预措施: Placebo (Drug)
Group 6: Placebo
Participants will receive placebo BID from Week 0 through Week 16.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16
时间窗: Baseline (Week 0), Week 16
Percentage of participants who achieved PASI-75 score (greater than or equal to \[\>=\] 75% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
次要结局
- Change From Baseline in PASI Total Score at Week 16(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI-100) at Week 16(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16(At Week 16)
- Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16(At Week 16)
- Change From Baseline in Body Surface Area (BSA) at Week 16(Baseline (Week 0) and Week 16)
- Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16(Baseline (Week 0) and Week 16)
- Change From Baseline in PSSD Signs Score at Week 16(Baseline (Week 0) and Week 16)
- Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16(Baseline (Week 0) and Week 16)
- Percentage of Participants Who Achieved PSSD Symptoms Score Equal to (=) 0 at Week 16 Among Participants With a Baseline Symptoms Score Greater Than or Equal to (>=) 1(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved PSSD Sign Score = 0 at Week 16 Among Participants With a Baseline Sign Score >=1(Baseline (Week 0) , Week 16)
- Percentage of Participants Who Achieved a Dermatological Life Quality Index (DLQI) of 0 or 1 at Week 16 Among Participants With Baseline DLQI Score Greater Than (>) 1(Baseline (Week 0), Week 16)
- Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(From Week 0 through Week 20)
- Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16(Baseline (Week 0), Week 16)