CTIS2023-504447-14-00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 - TILD-19-12
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 81
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
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Parts A and B A subject must have met all the criteria listed below to participate in the study. - Subject must be 6 to = 17 years of age, of either sex, of any race/ ethnicity, must weigh > 15 kg at screening, -Subject has a negative evaluation for tuberculosis (TB) within 4 weeks before initiating Investigational medicinal product (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 of TB - A posterior-anterior (PA) chest radiogram (with associated report available at the site) performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases), - If prior latent TB infection, must have history of adequate prophylaxis (per local standard of care), - If presence of latent TB is established, then treatment according to local country guidelines must have been followed for 4 weeks, prior to inclusion in the study. A maximum of 2 QuantiFERON tests are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used., -Subject should have documentation of adequate, up-to-date, age-appropriate vaccination status at screening. If required, antibody titers may be checked at screening based on investigator’s discretion., -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 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, but are not limited to, condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed Intra uterine Device (IUD), inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). - Subject is a surgically sterilized female or is documented to be pre- menarchal, -For a female with childbearing potential, a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to the first dose of study medication and at all subsequent visits as per the schedule of assessments., - Subject is unlikely to conceive, as indicated by at least one yes” answer to the following questions: - Subject is male - Subject is a female of child-bearing potential and 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, but are not limited to, condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribe
排除标准
- •PART A and B - 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 any active or uncontrolled significant organ dysfunctionor clinically significant laboratory abnormalities or any condition that place, the subject at unacceptable risk for participation in a long-term trial of immunomodulatory therapy in the judgment of the Investigator., - Subject who, in the opinion of the investigator, will not be able to participate optimally in the trial., - Subjects who have a high risk of suicidality at the screening assessment based on the Investigator’s judgment or, if appropriate, as indicated by a response of yes” within the last 12 months to Questions 4 or 5 in the suicidal ideation section, or any positive response in the behavioral section of the C-SSRS, - Subject is receiving or is anticipated to receive any of the prohibited medications, supplements, and other substances listed in Table 4 during the course of 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 (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 immunomodulatory therapy are 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 that in the opinion of the Investigator could affect the trial outcome or present an unacceptable risk, - 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 who, in the opinion of the Investigator, will not be a reliable participant in the trial., - Subject who has a history of alcohol or drug abuse in the previous year., - 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., - Subjects with a history of psychiatric inp
研究者
相似试验
进行中（未招募）
1 期
This study is being done to see how good and safe Tildrakizumab is in children aged 6 to under 18 years of age with skin patchesmoderate to severe chronic plaque psoriasisEUCTR2019-003551-11-PLSun Pharmaceutical Industries Limited110
进行中（未招募）
1 期
This study is being done to see how good and safe Tildrakizumab is in children aged 6 to under 18 years of age with skin patchesmoderate to severe chronic plaque psoriasisEUCTR2019-003551-11-ESSun Pharma Advanced Research Company Ltd.120
进行中（未招募）
1 期
This study is being done to see how good and safe Tildrakizumab is in children aged 6 to under 18 years of age with skin patchesmoderate to severe chronic plaque psoriasisEUCTR2019-003551-11-HUSun Pharma Advanced Research Company Ltd.120
进行中（未招募）
2 期
A study of Tildrakizumab in children with moderate to severe psoriasis.CTRI/2023/05/052628Sun Pharmaceutical Industries Limited
进行中（未招募）
1 期
Study to see how good and safe Tildrakizumab is in children aged 6 to under 18 years of age with skin patches.EUCTR2019-003551-11-SKSun Pharma Industries Limited110