NL-OMON45724已完成3 期
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 6 to less than 12 Years of Age - CADMUS Jr. Psoriasis Study for Children
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
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) greater than or equal to 3, and involved body surface area (BSA)greater than or equal to 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 ;- Have received any systemic immunosuppressants 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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