EUCTR2019-003551-11-SK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
Sun Pharma Industries Limited0 个研究点目标入组 110 人开始时间: 2023年1月23日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •Part A and Part B
- •A subject must have met all the criteria listed below to participate in the base study.
- •1. Subject must be 6 to =17years of age at screening, of either sex, of any race/ethnicity, and must weigh > 15kg.
- •2. Diagnosis of predominantly plaque psoriasis for =6 months (as determined by subject interview and confirmation of diagnosis through physical examination by the Investigator).
- •3. Moderate to severe psoriasis at baseline defined as:
- •a. At least 10% BSA involvement
- •b. PGA score = 3
- •c. PASI score = 12
- •4. Subject must be considered a candidate for systemic therapy and/or phototherapy.
- •5. Subject has a negative evaluation for tuberculosis (TB) within 4 weeks 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 of TB,
- •- A posterior-anterior (PA) chest radiogram (with associated report available at the site) was 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 a history of adequate prophylaxis (per local standard of care),
- •- If the 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.
- •6. 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 the Investigator’s discretion.
- •7. Subject is unlikely to conceive, as indicated by at least one yes answer to the following questions:
- •a. Subject is a male.
- •b. 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 the administration of the last dose of the investigational and 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 Intrauterine 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).
- •c. Subject is a surgically sterilized female or is documented to be pre-menarchal.
- •8. For female subjects 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
- •9. Subject must have results of a physical examination within normal limits or clinically acceptable limits to the investigator prior to the first dose of study medication. The investigator is encouraged to consult with the medical monitor (or appropriate
排除标准
- •Part A and Part B
- •1. 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.
- •2. 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.
- •3. Subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial.
- •4. Female subject of childbearing potential who are pregnant or intends to become pregnant (within 6 months following administration of the last dose of the investigational medicinal product) or are lactating (Sexually active adolescent girls will be required to use contraception).
- •5. Subject with the presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening or severe infection
- •6. 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 would be allowed. However, the number of subjects with prior use of TNF-alpha inhibitors would be capped at 40%, and the analysis will be stratified based on prior use of these biologics. When the number of subjects with prior use of TNF-alpha inhibitors reaches 40% of the sample size, the study population will be re-evaluated with respect to the general psoriasis population, and the % cap may be revised, if found necessary.
- •7. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result.
- •8. 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).
- •9. 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, an entry into the study could be deferred until such vaccination is completed and adequate time (4 weeks) has elapsed until baseline.
- •10. 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).
- •11. 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.
- •12. Subject has been hospitalized due to an acute cardiovascular event, illness, or surgery within 6 months prior to screening.
- •13. Within 6 months prior to screening, any significant organ dysfunction or clinically significa
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