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A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03997786
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date June 25, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Part A - Maximum Plasma Concentration [ Time Frame: Day 3, 7 and 28 following first dose ]
  • Part A - Area under the plasma concentration-time curve [ Time Frame: Day 3, 7 and 28 following first dose ]
  • Part A - Maximum Plasma Concentration [ Time Frame: Weeks 4,8, and 12 following second dose ]
  • Part A - Area under the plasma concentration-time curve [ Time Frame: Weeks 4,8, and 12 following second dose ]
  • Proportion of subjects with at least 75% improvement in the PASI response from baseline [ Time Frame: Week 12 ]
  • Proportion of subjects with PGA of "clear" or "almost clear" with at least a 2 grade reduction from baseline [ Time Frame: Week 12 ]
  • Number of subjects with adverse events [ Time Frame: Week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 50 from baseline [ Time Frame: Week 12, 16, 28, 40, 52, 64, 76 and 88 ]
  • Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 90 from baseline [ Time Frame: Week 12, 16, 28, 40, 52, 64, 76 and 88 ]
  • Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 100 from baseline [ Time Frame: Week 12, 16, 28, 40, 52, 64, 76 and 88 ]
  • Proportion of subjects achieving PASI 75 and PGA score of "clear" or "almost clear" with at least a 2 grade reduction from baseline [ Time Frame: Week 16, 28, 40, 52, 64, 76 and 88 ]
  • Change in quality of life as measured by Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Week 108 ]
    The CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's (aged 2-15 years) quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the children's life; 2-6 = small effect on the children's life; 7-12 = moderate effect on the children's life; 13-18 = very large effect on the children's life; 19-30 = extremely large effect on the children's life. Higher scores indicate more impact on quality of life of children.
  • Number of subjects with Adverse events [ Time Frame: Week 108 ]
  • Immunogenicity - Anti-drug antibody status [ Time Frame: Week 108 ]
  • Percent of subjects with severe infections [ Time Frame: Week 108 ]
    defined as any infection meeting the regulatory definition of a serious adverse event, or any infection requiring IV antibiotics whether or not reported as a serious event as per the regulatory definition
  • Percent of subjects with malignancies [ Time Frame: Week 108 ]
    including non-melanoma and melanoma skin cancer, but excluding carcinoma in situ of the cervix
  • Percent of subjects with confirmed major adverse cardiovascular events [ Time Frame: Week 108 ]
    major adverse cardiovascular events
  • Percent of subjects with drug- related hypersensitivity reactions [ Time Frame: Week 108 ]
    e.g. anaphylaxis, urticarial, angioedema, etc
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2019)
  • Relapse rates after withdrawal of treatment with tildrakizumab [ Time Frame: Week 52 ]
  • Rebound rates after withdrawal of treatment with tildrakizumab [ Time Frame: Week 52 ]
  • response to retreatment after relapse after withdrawal of treatment with tildrakizumab - Proportion of subjects with at least 75% improvement in the PASI response from baseline [ Time Frame: Week 52 ]
  • response to retreatment after relapse after withdrawal of treatment with tildrakizumab - Proportion of subjects with PGA of "clear" or "almost clear" with at least a 2 grade reduction from baseline [ Time Frame: Week 52 ]
  • Maintenance of response - Proportion of subjects with at least 75% improvement in the PASI response from baseline [ Time Frame: Week 52 ]
  • Maintenance of response - Proportion of subjects with PGA of "clear" or "almost clear" with at least a 2 grade reduction from baseline [ Time Frame: Week 52 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
Official Title  ICMJE 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
Brief Summary The study has been designed with two components. Part A is an open label PK study followed by a randomized trial component (Part B). The initial PK analysis is first done in adolescent subjects (12 to <18 years) before initiating the PK study in younger cohort (6 to <12 years)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The study will follow a two-component study design such that Part A will be an open label PK lead-in cohort of approximately 20 subjects. Part B will be a randomized trial component with approximately 100 subjects
Primary Purpose: Treatment
Condition  ICMJE Moderate-to-severe Chronic Plaque Psoriasis
Intervention  ICMJE
  • Drug: Tildrakizumab

    Part A: Pediatric subjects with a body weight in the highest category will be treated with the same dose as adult subjects (e.g. 100 mg for patients weighing >40 kg). Lower doses will be selected with the aim to achieve tildrakizumab plasma exposures in the clinically relevant range across all body weight(BW) categories (e.g. subjects weighing 15 -40 kg, will be given 2.5 mg/kg BW).

    Part B: Subcutaneous injection of tildrakizumab will be administered at Weeks 0 and 4

  • Drug: Placebo - tildrakizumab
    Subcutaneous injection of placebo will be administered at Weeks 0 and 4
  • Drug: Etanercept
    Etanercept will be administered at 0.8mg/kg (for subjects <63kg) and 50 mg (for subjects weighing >63kg body weight) weekly for 12 weeks
Study Arms  ICMJE
  • Placebo Comparator: Part B - Placebo
    Intervention: Drug: Placebo - tildrakizumab
  • Active Comparator: Part B - Etanercept
    Intervention: Drug: Etanercept
  • Experimental: Tildrakizumab
    Intervention: Drug: Tildrakizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2023
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be 6 to < 18 years of age, of either sex, of any race/ ethnicity, must weight greater than or equal to 15Kg.
  • Diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
  • Moderate to severe psoriasis at baseline defined as: at least 10% Body Surface Area (BSA) involvement, PGA score ≥ 3, and PASI score ≥ 12
  • Subject must be considered a candidate for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy
  • Subject is considered to be eligible according to tuberculosis (TB) screening criteria
  • A maximum of 2 QuantiFERON tests will be allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.

Exclusion Criteria:

  • 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: Alanine transaminase (ALT) or aspartate transaminase, (AST) ≥2X the upper limit of normal, Creatinine ≥1.5X the upper limit of normal serum direct bilirubin ≥ 1.5 mg/dL, white blood cell count < 3.0 x 103/μL, and 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 6 months of completing the trial), 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 215 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Head, Clinical Development 91 2266455645 clinical.trials@sparcmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997786
Other Study ID Numbers  ICMJE TILD-19-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sun Pharma Global FZE
Study Sponsor  ICMJE Sun Pharma Global FZE
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharma Global FZE
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP