EUCTR2016-000121-40-PL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 to less 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
- 44
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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