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临床试验/CTRI/2023/05/052628
CTRI/2023/05/052628已完成2/3 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

Sun Pharmaceutical Industries Limited7 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月6日最近更新:
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试验速览

阶段
2/3 期
状态
已完成
入组人数
120
试验地点
7
主要终点
Part B- To evaluate the efficacy of tildrakizumab with at least 75% improvement in the Psoriasis Area & Severity Index (PASI 75 response) from baseline and the proportion of subjects with Physician’s Global Assessment (PGA) score of “clear†or “minimal†with at least a 2-grade reduction from baseline at Week 16 compared to placebo.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Dose finding Component - To characterize pharmacokinetics(PK) and safety of tildrakizumab in pediatric subjects during a 16-weektreatment period in support of final pediatric dose selection

Randomized Trial Component- To evaluate the efficacy oftildrakizumab in pediatric subjects from 6 to <18 years of age with moderateto severe chronic plaque psoriasis as measured by the proportion of subjectswith at least 75% improvement in the Psoriasis Area & Severity Index (PASI75 response) from baseline, and the proportion of subjects with Physician’sGlobal Assessment (PGA) score of “clear†or “almost clear†with at least a 2grade reduction from baseline at Week 16 compared to placebo

To evaluate the efficacy of tildrakizumab in pediatricsubjects from 6 to <18 years of age with moderate to severe chronic plaquepsoriasis as measured by the proportion of subjects with at least 75%improvement in the Psoriasis Area & Severity Index (PASI 75 response) frombaseline, and the proportion of subjects with Physician’s Global Assessment(PGA) score of “clear†or “almost clear†with at least a 2 grade reduction frombaseline at Week 12 compared to placebo.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 17.00 Year(s)（—）
性别
All

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
  • •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.
  • •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.
  • •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 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)
  • •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
  • •Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result.
  • •Prior malignancy or concurrent malignancy.
  • •Subject who intends to receive live viral or bacterial vaccination during the trial.
  • •Subject who is currently participating in another interventional clinical trial.
  • •Subject has sustained, uncontrolled hypertension 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 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.
  • •Subjects with a history of psychiatric inpatient hospitalization within the past year
  • •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
  • •History of hypersensitivity to the applicable IMP or any ingredients of the study drug or placebo.

结局指标

主要结局

Part B- To evaluate the efficacy of tildrakizumab with at least 75% improvement in the Psoriasis Area &amp; Severity Index (PASI 75 response) from baseline and the proportion of subjects with Physician’s Global Assessment (PGA) score of “clear†or “minimal†with at least a 2-grade reduction from baseline at Week 16 compared to placebo.

时间窗: Week 16

Part A - To characterize PK and safety of tildrakizumab in pediatric subjects during a 16-week treatment period in support of final pediatric dose selection

时间窗: Week 16

次要结局

  • Change from baseline in Children’s Dermatology Life Quality IndexCDLQI/ Dermatology Life Quality Index DLQI(Weeks 4, 8, 12, 16, 28, 40 and 52.)
  • Mean change from baseline in Itch, pain and scaling NRS(Weeks 4, 8, 12, 16, 28, 40 and 52)
  • Median time to loss of remission in subjects achieving remission(Week 16)
  • The proportion of subjects with malignancies (including non-melanoma and melanoma skin cancer, but excluding carcinoma in situ of the cervix) over 52 weeks(Week 52)
  • The proportion of subjects with PASI 50, PASI 90 and PASI 100 response(Weeks 4, 8, 12, 16, 28, 40 and 52.)
  • The proportion of PGA responders at Week 16 who maintained response on continued treatment with Tildrakizumab through Week 52(Week 52)
  • The proportion of subjects achieving remission with tildrakizumab treatment(Week 16)
  • Incidence and severity of adverse events.(Part A- Upto Week 16)
  • The proportion of subjects responding to re-treatment on relapse and rebound of the disease on withdrawal from tildrakizumab treatment(until week 16 from the relapse or rebound)
  • Percentage of subjects with severe infection over 52 weeks(Week 52)
  • The proportion of subjects with drug-related hypersensitivity reactions (e.g., anaphylaxis, urticarial, angioedema, etc.) over 52 weeks(Week 52)
  • Incidence of immunogenicity over 52 weeks after treatment with tildrakizumab(Week 52)
  • Median time to relapse (defined as reduction by greater than 50 percent in maximum improvement achieved at week 16) upon withdrawal of tildrakizumab in subjects responding at Week 16(Week 16)
  • The proportion of subjects with PASI 75 score (PASI 75 response)(week 4, 8, 12, 28, 40 and 52)
  • The proportion of tildrakizumab responders at week 16 who relapse over 52 weeks upon treatment withdrawal(Week 52)
  • The proportion of subjects with injection site reaction over 52 weeks(Week 52)
  • The proportion of subjects with PGA score of “clear†or “minimal with at least a 2 grade reduction from baseline(Week 4, 8, 12, 28, 40 and 52.)
  • The proportion of tildrakizumab responders at Week 16 who rebound over 52 weeks upon treatment withdrawal(Week 52)
  • The proportion of subjects with MACE (Major Adverse Cardiovascular Events) over 52 weeks(Week 52)
  • Median time to relapse(defined as a PGA score of greater than or equal to 3)upon withdrawal of tildrakizumab in subjects responding at Week 16(Week 16)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (7)

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