EUCTR2019-003551-11-PL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
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •-Subject must be 6 to =17, of either sex, of any race/ ethnicity
- •-Must weigh >15 Kg at screening
- •-Diagnosis of predominantly plaque psoriasis for =6 mths
- •Moderate to severe psoriasis at baseline defined as:
- •-At least 10% body surface area involvement
- •-PGA score =3
- •-PASI score =12
- •-Subject must be considered a candidate for systemic therapy &/or phototherapy
- •Subject has a negative evaluation for tuberculosis within 4 wks before initiating IMP defined as a negative QuantiFERON test. Subjects with a positive or 2 successive indeterminate QuantiFERON tests are allowed if they have all of the following:
- •-No history of active TB or symptoms
- •-A posterior-anterior chest radiogram performed within 3 mths of Screening with no evidence of active TB
- •-If prior latent TB infection must have history of adequate prophylaxis
- •-If presence of latent TB is established then treatment according to local country guidelines must have been followed for 4 wks prior to inclusion in the study
- •A max of 2 QuantiFERON tests. A retest is only permitted if the 1st is indeterminate; the result of the 2nd test will then be used
- •-Subject should have documentation of adequate, up-to-date, age-appropriate vaccination status at screening. Antibody titers may be checked at screening based on investigators discretion
- •- Subject is unlikely to conceive as indicated by at least 1 yes answer to the following questions:
- •- Subject is a male
- •- Subject is a female of child-bearing potential & agrees to abstain from heterosexual activity OR use a medically accepted method of contraception OR use appropriate effective contraception as per local regulations or guidelines for continued use during the study and for 6 months following administration of the last dose of the investigational medicinal product. Medically accepted methods of contraception include, condoms with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization. Male subjects with female partners of childbearing potential who are not using birth control must use a barrier method of contraception if not surgically sterile
- •- Subject is a surgically sterilized female or is documented to be premenarchal
- •- For a female with childbearing potential a negative serum pregnancy test at Screening & a negative urine pregnancy test within 24 h prior to the 1st dose of study medication & at all subsequent visits as per schedule of assessment
- •- Subject must have results of a physical examination within normal limits or clinically acceptable limits to the investigator prior to the 1st dose of study medication. The investigator is encouraged to consult with the medical monitor if there are questions regarding the significance of any out of range values. Laboratory abnormalities deemed not clinically significant by the investigator should be clarified with the CRO or Sponsor MM
- •-To participate in whole body photography at designated sites the subject must be willing to give assent/written informed consent and be able to adhere to dose/visit schedules. Photography will be an optional procedure for subjects to participate in. Photography will not be applicable to Part A.
- •-Willingness & ability to comply with the protocol
- •-Subject has completed at least 64 weeks of Part B of the study.
- •Subjects rolled over from Part A to Part B to receive open
排除标准
- •- 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 or aspartate transaminase =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 following administration of the last dose of the investigational medicinal product) or are lactating
- •- 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 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. When the number of subjects with prior use of TNF –alpha inhibitors reach 40% of sample size, study population will be reevaluated with respect to general psoriasis population and % cap may be revised, if found necessary
- •- Positive human immunodeficiency virus test result, hepatitis B surface antigen, or hepatitis C virus test result
- •- Prior malignancy or concurrent malignancy
- •- 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. Note: If needed, entry in to the study could be deferred until such vaccination is completed and adequate time has elapsed until baseline
- •- Subject who is currently participating in another interventional clinical trial or has participated in an interventional clinical trial within 5 halflives to wash out prior to randomization
- •- Subject has sustained, uncontrolled hypertension (defined as average SBP and/or DBP that is greater than or equal to the 95th percentile for sex, age, and height on three or more occasions), or has uncontrolled diabetes.
- •- Subject has been hospitalized due to an acute cardiovascular event, illness or surgery within 6 months prior to screening
- •- 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 present an unacceptable risk
- •- Subject who, in the opinion of the investigator, will not be a reliable participant in the trial.
- •- Subjects who have high risk of suicidality at the screening assessment based on Investigator's judgment or, if appropriate, as indicated by a response
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