EUCTR2016-000121-40-BE进行中（未招募）1 期
A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics ofSubcutaneously Administered Ustekinumab in the Treatment of Moderateto Severe Chronic Plaque Psoriasis in Pediatric Subjects greater than 6 toless than 12 Years of Age
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
研究者
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