EUCTR2019-003551-11-HU进行中（未招募）1 期
A Multicenter, Randomized, Placebo and Active Comparator-Controlled Clinical trial to Study the Efficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects from 6 to <18 Years of Age with Moderate to Severe Chronic Plaque Psoriasis
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
- 120
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
- •A subject must have met all the criteria listed below to participate in the study.
- •- Subject must be 6 to < 18 years of age, of either sex, of any race/ ethnicity, must weigh > 15 Kg.
- •- Diagnosis of predominantly plaque psoriasis for =6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
- •- Moderate to severe psoriasis at baseline defined as :
- •- At least 10% Body Surface Area (BSA) involvement
- •- PGA score = 3
- •- PASI score = 12
- •- Subject must be considered a candidate for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy
- •- Subject is considered to be eligible according to the following tuberculosis (TB) screening criteria:
- •a.Has no history of untreated latent or active TB prior to screening. Prophylactic treatment for latent TB (as per local guidelines) must be initiated at least 4 weeks prior to first administration of study medication.
- •b. Has no signs or symptoms suggestive of active TB upon
- •medical history and/or physical examination.
- •c. Has had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB at least 4 weeks prior to the first administration of study medication.
- •d. Within 4 weeks prior to first administration of study
- •medication, either has negative diagnostic TB test results (defined as a negative tuberculin skin test ) or a negative QuantiFERON-TB Gold test.
- •e. A subject who has a positive intradermal skin test or
- •positive QuantiFERON-TB Gold test, or who has had recent close contact with a person with active TB, or has signs or symptoms suggestive of active TB upon medical history and/or physical examination, or if required by local guidelines or regulations as part of routine TB screening, must have a negative chest radiograph (both posterior-anterior and lateral views) or chest computed tomography (CT) scan taken within 4 weeks prior to first administration of study medication. The radiograph or scan must be read by a qualified radiologist, and must have no evidence of current active TB or old inactive TB. (Note: If either the tuberculin skin or QuantiFERON-TB Gold test is positive, and the chest radiograph or chest CT scan is negative, the subject is considered to have latent TB infection [LTBI]. Subjects with LTBI may be included if they receive prophylactic treatment for latent TB or have previously completed an adequate course of prophylactic treatment according to local guidelines or regulations without subsequent new exposure to active TB. The investigator is strongly encouraged to consider referral to a TB specialist to assess the need for repeat of prophylactic therapy if there is a history of new exposure to active TB subsequent to completion of prior treatment for LTBI or if prior treatment of LTBI was completed more than 3 months prior to screening.)
- •-A maximum of 2 QuantiFERON tests will be allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.
- •- Subject is unlikely to conceive, as indicated by at least one yes answer to the following questions:
- •- Subject is a male.
- •- Subject is a female of child-bearing potential and agrees to abstain from heterosexual activity OR use a medically acce
排除标准
- •A subject meeting any of the exclusion criteria listed below must be excluded from participating in the trial:
- •- Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
- •- Subject has laboratory abnormalities at screening including any of the following:
- •a) Alanine transaminase (ALT) or aspartate transaminase (AST) =2X the upper limit of normal
- •b) Creatinine =1.5X the upper limit of normal
- •c) serum direct bilirubin = 1.5 mg/dL
- •d) white blood cell count < 3.0 x 103/µL
- •e) any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
- •- Subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial.
- •- Female subjects of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial), or are lactating. (Sexually active adolescent girls will be required to use contraception)
- •- Subject with presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening
- •- Subject with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis. (Prior use of TNF-alpha inhibitors will be allowed. However, the number of subjects with prior use of TNF-alpha inhibitors will be capped at 40% and the analysis will be stratified based on prior use of these biologics)
- •- Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result.
- •- Prior malignancy or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated).
- •- Subject who has received live viral or bacterial vaccination within 4 weeks prior to baseline or who intends to receive live viral or bacterial vaccination during the trial.
- •- Subject who is currently participating in another interventional clinical trial or has participated in an interventional clinical trial within 5 half-lives (of the drug) to wash out prior to randomization. (Subjects participating in observational studies or non-interventional registry studies may be included in the study)
- •- Subject has sustained, uncontrolled hypertension (systolic blood pressure of =160 mmHg and/or diastolic blood pressure of =100 mmHg at Screening), or has uncontrolled diabetes.
- •- Within 6 months prior to screening, any significant organ dysfunction or clinically significant laboratory abnormalities that place the subject at unacceptable risk for participation in a trial of an immunomodulatory therapy in the judgment of the investigator.
- •- The subject or a family member is among the personnel of the investigational site or sponsor/designee staff directly involved with this trial.
- •- Any concomitant medical condition which in the opinion of the investigator could affect the trial outcome or
研究者
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