CTRI/2023/05/052628进行中（未招募）2 期
A Multicenter, Randomized, Placebo and Active Comparator-Controlled Clinical Trial to Study theEfficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects from 6 to less than 18 Years of Age with Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
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
入选标准
- •1.Subject must be 6 to less than or equal to 17 years of age, of either sex, of any race/ ethnicity, must weigh greater than 15 kg at screening. 2.Diagnosis of predominantly plaque psoriasis for greater than or equal to 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator). 3.Moderate to severe psoriasis at baseline defined as :- At least 10% body surface area (BSA) involvement , PGA score greater than or equal to 3, PASI score greater than or equal to 12. 4.Subject must be considered a candidate for systemic therapy and/or phototherapy. 5.Subject has a negative evaluation for tuberculosis (TB).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. 7.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. Subject is a surgically sterilized female or is documented to be pre- menarchal.8.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.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. 10.To participate in whole-body photography at designated sites, the subject must be willing to give assent or written informed consent and be able to adhere to dose and visit schedules. Photography will be an optional procedure for subjects to participate in the trial.
排除标准
- •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) greater than or equal to 2X the upper limit of normal
- •b) Creatinine greater than or equal to 1.5X the upper limit of normal.
- •c) Serum direct bilirubin greater than or equal to 1.5 mg/dL
- •d) White blood cell count less than 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 subjects of childbearing potential who are pregnant or intend 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 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
- •6. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result.
- •7. Prior malignancy or concurrent malignancy.
- •8. Subject who intends to receive live viral or bacterial vaccination during the trial.
- •9. Subject who is currently participating in another interventional clinical trial.
- •10. Subject has sustained, uncontrolled hypertension or has uncontrolled diabetes.
- •11. Subject has been hospitalized due to an acute cardiovascular event, illness or surgery within 6 months prior to screening
- •12. 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.
- •13. The subject or a family member is among the personnel of the investigational site or sponsor/designee staff directly involved with this trial.
- •14. Any concomitant medical condition that in the opinion of the Investigator could affect the trial outcome or present an unacceptable risk
- •15. Subject who, in the opinion of the Investigator, will not be a reliable participant in the trial.
- •16. Subject who has a history of alcohol or drug abuse in the previous year.
- •17. Subjects with a history of psychiatric inpatient hospitalization within the past year
- •18. Subjects with any other clinically significant 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
- •19. History of hypersensitivity to the applicable IMP or any ingredients of the study drug or placebo.
研究者
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