A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 774
- 试验地点
- 164
- 主要终点
- Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
研究概览
简要总结
The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.
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
- •Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
- •Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
- •Total psoriasis area and severity index (PASI) >=12 at screening and baseline
- •Total investigator global assessment (IGA) >=3 at screening and baseline
- •Candidate for phototherapy or systemic treatment for plaque psoriasis
排除标准
- •Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- •Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib, or to any of the excipients or components of the study intervention
- •Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study
研究组 & 干预措施
JNJ-77242113
Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
干预措施: Deucravacitinib Matching Placebo (Drug)
Placebo
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.
干预措施: Deucravacitinib Matching Placebo (Drug)
Placebo
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.
干预措施: JNJ-77242113 Matching Placebo (Drug)
Placebo
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.
干预措施: JNJ-77242113 (Drug)
Deucravacitinib
Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.
干预措施: JNJ-77242113 Matching Placebo (Drug)
JNJ-77242113
Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
干预措施: JNJ-77242113 (Drug)
Deucravacitinib
Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.
干预措施: JNJ-77242113 (Drug)
Deucravacitinib
Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
时间窗: Week 16
IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema, scaling, each using 5 point scale. Induration:0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25 millimeters(mm); 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation,\>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe(4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
时间窗: Week 16
Percentage of participants who achieved PASI-90 score (\>=90% 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 was 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
- Percentage of Participants Who Achieved IGA Score of 0 at Week 16(Week 16)
- Percentage of Participants Who Achieved PASI 75 at Weeks 4 and 16(Weeks 4 and 16)
- Percentage of Participants Who Achieved PASI 90 at Week 8(Week 8)
- Percentage of Participants Who Achieved PASI 100 at Week 16(Week 16)
- Percentage of Participants Who Achieved a Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2(Week 16)
- Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0(Weeks 8 and 16)
- Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 Among Participants With a Baseline PSSD Itch Score >=4(Weeks 4 and 16)
- Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24(Weeks 16 and 24)
- Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24(Weeks 16 and 24)
- Percentage of Participants Who Achieved PASI 75 at Weeks 16 and 24(Weeks 16 and 24)
- Percentage of Participants Who Achieved PASI 90 at Weeks 16 and 24(Weeks 16 and 24)
- Percentage of Participants Who Achieved PASI 100 at Weeks 16 and 24(Weeks 16 and 24)
- Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline Symptom Score >0(Week 16)
- Change From Baseline in Body Surface Area (BSA) at Week 16(Baseline (Week 0), Week 16)
- Change From Baseline in PASI Total Score at Week 16(Baseline (Week 0), Week 16)
- Percent Change From Baseline in PASI Total Score at Week 16(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline sPGA-G Score >=2(Week 16)
- Change From Baseline in PSSD Sign Score at Week 16(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0(Week 16)
- Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2(Week 16)
- Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With a Baseline mNAPSI Score >0(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With Baseline f-PGA Score >=2(Week 16)
- Change From Baseline in PSSD Symptom Score at Week 16(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With a Baseline GenPS-SFQ Item 2 Score >=2 and With a Baseline sPGA-G Score >=3(Week 16)
- Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1(Week 16)
- Change From Baseline in Total DLQI Score at Week 16(Baseline (Week 0), Week 16)
- Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16(Baseline (Week 0), Week 16)
- Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1(Weeks 16 and 24)
- Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 24 Among Participants With Baseline Symptom Score >0(Week 24)
- Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24(Week 24 up to Week 160)
- Percentage of Participants Who Achieved PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24(Week 24 up to Week 160)
- Percentage of Participants Who Achieved IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24(Week 24 up to Week 160)
- Number of Participants With Adverse Events (AEs)(From Week 0 to Week 160)
- Number of Participants With Serious Adverse Events (SAEs)(From Week 0 to Week 160)