A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects Greater Than or Equal to 6 to Less Than 12 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (>=) 6 through less than (<) 12 years with moderate to severe chronic plaque psoriasis
详细描述
This is an open label (identity of study drug will be known to participant and study staff) and multicenter (when more than one hospital or medical school team work on a medical research study) study. The participant population will be comprised of boys and girls who have had a diagnosis of plaque psoriasis for at least 6 months prior to first study drug administration and who have moderate to severe disease defined by Psoriasis Area and Severity Index score (PASI) >=12, Physician's Global Assessment (PGA) >=3, and Body Surface Area (BSA) >=10 percent (%). The study consists of Screening Phase (up to 10 weeks before administration of the study drug), Treatment Period (Week 0 up to Week 52) and Safety follow up (Week 56). Participants will be primarily evaluated for efficacy, pharmacokinetics (PK) and safety. Following completion of the Week 52 visit, participants who have had a beneficial response from ustekinumab treatment as determined by the investigator, and who have not yet reached the age of 12 years or older in countries where marketing authorization for ustekinumab has been granted for the treatment of psoriasis in adolescent participants (12-17 years), and are willing to continue ustekinumab treatment, may enter the long-term extension period (from Week 56 through Week 264) of the study.
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months prior to first administration of study drug, with widespread lesions defined by Psoriasis Area and Severity Index score (PASI) greater than or equal to (>=) 12, Physician's Global Assessment (PGA) >=3, and involved body surface area (BSA) >=10 percent (%)
- •Participants who are candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment) or have psoriasis considered by the investigator as poorly controlled with topical therapy after an adequate dose and duration of therapy
- •Participants who are considered eligible according to the protocol defined tuberculosis (TB) screening criteria
- •Participants must have positive protective antibody titers to varicella and measles prior to the first administration of study drug. In the absence of positive protective antibody titers, the participant must have documentation of age-appropriate vaccination for varicella and/or measles (that includes both doses of each vaccine) or verification of past varicella and/or measles infection documented by a health care provider
- •Participants must agree not to receive a live virus or live bacterial vaccination at least 2 weeks (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study drug, during the study, or within 15 weeks after the last administration of study drug
- •Participants must agree not to receive a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening, during the study, or within 12 months after the last administration of study drug
排除标准
- •Participants who currently have nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)
- •Have received any systemic immunosuppressants (example methotrexate [MTX], azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of the first administration of study drug
- •Have received any biologic agent (example ENBREL, HUMIRA) within the previous 3 months or 5 times the t1/2 of the agent, whichever is longer
- •Have a history of chronic or recurrent infectious disease
- •Have a history of latent or active granulomatous infection
- •Have any known malignancy or have a history of malignancy
- •Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease
研究组 & 干预措施
Ustekinumab Group
Participants will receive 1 of the following dose levels depending on their weight: participants weighing less than (<) 60 kg will receive Ustekinumab 0.75 milligram per kilogram (mg/kg); participants weighing greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg will receive ustekinumab 45 mg; participants weighing >100 kg will receive ustekinumab 90 mg, at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants who enter the long-term extension (LTE) period will continue receiving ustekinumab every 12 weeks (q12w) beginning at Week 56 up to Week 248.
干预措施: Ustekinumab 0.75 mg/kg (Drug)
Ustekinumab Group
Participants will receive 1 of the following dose levels depending on their weight: participants weighing less than (<) 60 kg will receive Ustekinumab 0.75 milligram per kilogram (mg/kg); participants weighing greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg will receive ustekinumab 45 mg; participants weighing >100 kg will receive ustekinumab 90 mg, at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants who enter the long-term extension (LTE) period will continue receiving ustekinumab every 12 weeks (q12w) beginning at Week 56 up to Week 248.
干预措施: Ustekinumab 45 mg (Drug)
Ustekinumab Group
Participants will receive 1 of the following dose levels depending on their weight: participants weighing less than (<) 60 kg will receive Ustekinumab 0.75 milligram per kilogram (mg/kg); participants weighing greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg will receive ustekinumab 45 mg; participants weighing >100 kg will receive ustekinumab 90 mg, at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants who enter the long-term extension (LTE) period will continue receiving ustekinumab every 12 weeks (q12w) beginning at Week 56 up to Week 248.
干预措施: Ustekinumab 90 mg (Drug)
结局指标
主要结局
Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
时间窗: Week 12
The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. Treatment Failure (TF) criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
次要结局
- Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12(Baseline and Week 12)
- Percentage of Participants Who Achieved PASI 90 Response at Week 12(Week 12)
- Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1(Week 12)
- Change From Baseline in CDLQI Component Scores at Week 12(Baseline and Week 12)
- Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176(Weeks 80, 104, 128, 152, 176)
- Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52(Weeks 4, 8, 12, 16, 28, 40, and 52)
- Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52(Baseline and Weeks 4, 8, 12, 16, 28, 40, 52)
- Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12(Week 12)
- Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1(Weeks 4, 12, 28, and 52)
- Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52(Weeks 4, 8, 12, 16, 28, 40, and 52)
- Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12(Week 12)
- Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52(Baseline and Weeks 4, 12, 28, 52)