A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 57
- 主要终点
- Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without psoriatic arthritis [PsA]), prior to first administration of study intervention, defined as having at screening and baseline, Investigator Global Assessment (IGA) greater than or equal to (>=) 3, Psoriasis Area and Severity Index (PASI) >=12, >=10% body surface area (BSA) involvement and at least one of the following: very thick lesions, clinically relevant facial, genital, or hand/ foot involvement, PASI>=20, >20% BSA involvement, or IGA=4
- •Be a candidate for phototherapy or systemic treatment of plaque psoriasis (either naive or history of previous treatment)
- •Have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy and/or topical therapy after an adequate dose and duration of therapy
- •Be considered, in the opinion of the investigator, a suitable candidate for etanercept therapy, according to their country's approved Enbrel product labeling
- •Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Must have acceptable evidence of immunity to varicella and measles, mumps, and rubella (MMR), which includes any one of the following: documentation of age-appropriate vaccination that includes both doses of each vaccine (unless local guidelines specify otherwise) or documentation of past infection by a healthcare provider or in the absence of previous 2 criteria, participants must have positive protective antibody titers to these infection prior to the first administration of study intervention. For participants who have not completed the recommended vaccination schedule for varicella and MMR, and the subsequent vaccination falls within the next 4 years, an accelerated vaccination schedule must be completed prior to study enrollment if available and required or strongly recommended for the location. If varicella or MMR vaccines are utilized, it is necessary for 2 weeks to elapse between the vaccination and receipt of study intervention
排除标准
- •Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)
- •Has current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •Has previously received guselkumab or etanercept
- •Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
- •Has a known history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
研究组 & 干预措施
Part 1 Group 1: Guselkumab
Participants in Part 1a (age greater than or equal to (>=) 12 - less than (<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose >=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.
干预措施: Placebo for guselkumab (Drug)
Part 1 Group 2: Placebo for Guselkumab
Participants in Part 1a (age >= 12 - <18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose >=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.
干预措施: Guselkumab (Drug)
Part 1 Group 1: Guselkumab
Participants in Part 1a (age greater than or equal to (>=) 12 - less than (<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose >=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.
干预措施: Guselkumab (Drug)
Part 1 Group 2: Placebo for Guselkumab
Participants in Part 1a (age >= 12 - <18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose >=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.
干预措施: Placebo for guselkumab (Drug)
Part 1 Group 3: Etanercept
Participants in Part 1a (age >= 12 - <18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.
干预措施: Guselkumab (Drug)
Part 2: Guselkumab
Participants will receive a weight-based dose of open-label guselkumab SC at Weeks 0, 4 and q8w thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE of the study and continue to receive guselkumab at Week 52 and q8w thereafter.
干预措施: Guselkumab (Drug)
Part 1 Group 3: Etanercept
Participants in Part 1a (age >= 12 - <18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.
干预措施: Etanercept (Drug)
结局指标
主要结局
Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
时间窗: At Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 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 the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
时间窗: At Week 16
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 separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.
次要结局
- LTE Phase: Percent Improvement in PASI Responses (PASI 50, 75, 90, and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52(Week 60 and Week 84)
- LTE Phase: Change From Baseline in BSA at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52(Week 60 and Week 84)
- Part 1: Percentage of Participants Who Achieve PASI 90 Response at Week 16(At Week 16)
- Part 1: Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16(At Week 16)
- Part 1: Percentage of Participants Who Achieved PASI 100 Response at Week 16(At Week 16)
- Part 1: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 16(Baseline and Week 16)
- Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment(At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52))
- Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment(At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52))
- Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment(At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52))
- Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16(Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16(Week 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Part 1: Percentage of Participants Who Achieved a PASI 50 Response at Week 16(At Week 16)
- Part 1: Percent Improvement From Baseline in PASI Through Week 16(Weeks 4, 8, 12, and 16)
- Part 2: Percent Improvement From Baseline in PASI Through Week 52(Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52)
- Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16(Weeks 4, 8, 12, and 16)
- Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52(Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52)
- Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16(Weeks 4, 8, 12, and 16)
- Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52(Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52)
- Part 2: Change From Baseline in CDLQI Score Through Week 52(Baseline, Weeks 8, 16, 28, 36, and 52)
- Part 1: Percentage of Participants With CDLQI Score Equal to 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score Greater Than (>) 1(At Week 16)
- Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1(Weeks 8, 16, 28, 36, and 52)
- Part 1: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 at Week 16 Among Participants With a Baseline FDLQI >1(At Week 16)
- Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1(Weeks 8, 16, 28, 36, and 52)
- Part 1: Change From Baseline in FDLQI Score at Week 16(Baseline and Week 16)
- Part 2: Change From Baseline in FDLQI Score Through Week 52(Baseline, Weeks 8, 16, 28, 36, and 52)
- Part 1: Change From Baseline in Body Surface Area (BSA) With Psoriasis Skin Involvement at Week 16(Baseline and Week 16)
- Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52(Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52)
- LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time(From Week 52 to End of the study (EOS) (December 2026))
- LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] Over Time(From Week 52 to EOS (December 2026))
- LTE Phase: Percent Improvement From Baseline in PASI Over Time(From Week 52 to EOS (December 2026))
- LTE Phase: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time(From Week 52 to EOS (Dec 2026))
- LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90,and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Participants Who Were Withdrawn From Guselkumab at Week 16 and Retreated Upon Loss of Response or at Week 52(Week 60 and Week 84)
- LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] at Weeks 60 and 84 After Retreatment(Week 60 and Week 84)