A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
NCT ID: NCT03997786
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
130 participants
INTERVENTIONAL
2020-01-15
2031-12-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
NCT01100034
Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis
NCT06982352
Etanercept (Enbrel®) in Psoriasis - Pediatrics
NCT00078819
Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
NCT05172726
The Efficacy and Safety of SHR-1314 in the Treatment of Pediatric Patients of Age 6 to <18 Years With Moderate to Severe Plaque Psoriasis
NCT06833307
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A
Part A is a DOSE FINDING COMPONENT: OPEN LABEL PK lead-in and safety component
Tildrakizumab
Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)
Part B Part 1: Placebo and active comparator controlled study
Placebo
(Weeks 0 to 16)
Tildrakizumab
(Weeks 0 to 16)
Etanercept
(Weeks 0 to 16)
Part B-1 and B-2: Randomized withdrawal and retreatment after relapse
Tildrakizumab
(Weeks 16 to 52)
Placebo
(Weeks 16 to 52)
Part B 3: Efficacy and Safety Follow-up
No interventions assigned to this group
Part C: LTE
Tildrakizumab
at every 12 weeks in open label fashion till 5 years (240 weeks).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tildrakizumab
Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)
Placebo
(Weeks 0 to 16)
Tildrakizumab
(Weeks 16 to 52)
Tildrakizumab
at every 12 weeks in open label fashion till 5 years (240 weeks).
Tildrakizumab
(Weeks 0 to 16)
Etanercept
(Weeks 0 to 16)
Placebo
(Weeks 16 to 52)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
6 Years
215 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Site 64
Kaposvár, , Hungary
Site 28
Szeged, , Hungary
Site 79
Ahmedabad, , India
Site 70
Ahmedabad, , India
Site 78
Chennai, , India
Site 75
Kolkata, , India
Site 76
Kolkata, , India
Site 71
Lucknow, , India
Site 73
Pune, , India
Site 74
Surat, , India
Site 77
Surat, , India
Site 80
Warangal, , India
Site 57
Bialystok, , Poland
Site 55
Gdansk, , Poland
Site 51
Katowice, , Poland
Site 54
Lodz, , Poland
Site 56
Lodz, , Poland
Site 58
Lublin, , Poland
Site 50
Ostrowiec Świętokrzyski, , Poland
Site 59
Sosnowiec, , Poland
Site 52
Szczecin, , Poland
Site 53
Warsaw, , Poland
Site 40
Wroclaw, , Poland
Site 39
Wroclaw, , Poland
Site 38
Wroclaw, , Poland
Site 92
Bardejov, , Slovakia
Site 91
Svidník, , 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TILD-19-12
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.