A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
- Conditions
- Moderate-to-severe Chronic Plaque Psoriasis
- Interventions
- Registration Number
- NCT03997786
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE).
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 available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B Part 1: Placebo and active comparator controlled study Etanercept - Part B-1 and B-2: Randomized withdrawal and retreatment after relapse Placebo - Part C: LTE Tildrakizumab - Part B Part 1: Placebo and active comparator controlled study Placebo - Part A Tildrakizumab Part A is a DOSE FINDING COMPONENT: OPEN LABEL PK lead-in and safety component Part B Part 1: Placebo and active comparator controlled study Tildrakizumab - Part B-1 and B-2: Randomized withdrawal and retreatment after relapse Tildrakizumab -
- Primary Outcome Measures
Name Time Method Part A - Area under the plasma concentration-time curve Weeks 4,8, and 12 following second dose Proportion of subjects with PGA of "clear" or "almost clear" with at least a 2 grade reduction from baseline Week 12 Proportion of subjects with at least 75% improvement in the PASI response from baseline Week 12 Part A - Maximum Plasma Concentration Weeks 4,8, and 12 following second dose Number of subjects with adverse events Week 52
- Secondary Outcome Measures
Name Time Method Number of subjects with Adverse events Week 108 Percent of subjects with severe infections 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 confirmed major adverse cardiovascular events Week 108 major adverse cardiovascular events
Percent of subjects with drug- related hypersensitivity reactions Week 108 e.g. anaphylaxis, urticarial, angioedema, etc
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 50 from baseline Week 12, 16, 28, 40, 52, 64, 76 and 88 Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 90 from baseline 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 Week 16, 28, 40, 52, 64, 76 and 88 Immunogenicity - Anti-drug antibody status Week 108 Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 100 from baseline Week 12, 16, 28, 40, 52, 64, 76 and 88 Change in quality of life as measured by Children's Dermatology Life Quality Index (CDLQI) 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.
Percent of subjects with malignancies Week 108 including non-melanoma and melanoma skin cancer, but excluding carcinoma in situ of the cervix
Trial Locations
- Locations (50)
Site 57
🇵🇱Bialystok, Poland
Site 55
🇵🇱Gdańsk, Poland
Site 51
🇵🇱Katowice, Poland
Site 54
🇵🇱Lodz, Poland
Site 56
🇵🇱Lodz, Poland
Site 58
🇵🇱Lublin, Poland
Site 76
🇮🇳Kolkata, India
Site 78
🇮🇳Chennai, India
Site 73
🇮🇳Pune, India
Site 70
🇮🇳Ahmedabad, India
Site 50
🇵🇱Ostrowiec Swietokrzyski, Poland
Site 59
🇵🇱Sosnowiec, Poland
Site 52
🇵🇱Szczecin, Poland
Site 53
🇵🇱Warszawa, Poland
Site 40
🇵🇱Wrocław, Poland
Site 39
🇵🇱Wrocław, Poland
Site 38
🇵🇱Wrocław, Poland
Site 92
🇸🇰Bardejov, Slovakia
Site 91
🇸🇰Svidnik, Slovakia
Site 90
🇸🇰Trnava, Slovakia
Site 41
🇪🇸Barcelona, Spain
Site 47
🇪🇸Las Palmas De Gran Canaria, Spain
Site 42
🇪🇸Madrid, Spain
Site 44
🇪🇸Valencia, Spain
Site 45
🇪🇸Valencia, Spain
Site 80
🇮🇳Warangal, India
Site 75
🇮🇳Kolkata, India
Site 71
🇮🇳Lucknow, India
Site 64
🇭🇺Kaposvar, Hungary
Site 74
🇮🇳Surat, India
Site 77
🇮🇳Surat, India
Site 28
🇭🇺Szeged, Hungary
Site 79
🇮🇳Ahmedabad, India
Site 23
🇺🇸Birmingham, Alabama, United States
Site 1
🇺🇸Fountain Valley, California, United States
Site 2
🇺🇸Thousand Oaks, California, United States
Site 4
🇺🇸Clearwater, Florida, United States
Site 24
🇺🇸Coral Gables, Florida, United States
Site 20
🇺🇸Miami, Florida, United States
Site 7
🇺🇸Miami, Florida, United States
Site 12
🇺🇸Orlando, Florida, United States
Site 5
🇺🇸Bay City, Michigan, United States
Site 16
🇺🇸Troy, Michigan, United States
Site 22
🇺🇸Saint Joseph, Missouri, United States
Site 8
🇺🇸Dallas, Texas, United States
Site 10
🇺🇸South Jordan, Utah, United States
Site 14
🇺🇸Spokane, Washington, United States
Site 63
🇭🇺Budapest, Hungary
Site 62
🇭🇺Budapest, Hungary
Site 61
🇭🇺Debrecen, Hungary