New hope for kids with severe psoriasis: drug trial shows promise
NCT ID NCT03997786
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called tildrakizumab in children aged 6 to 17 with moderate-to-severe plaque psoriasis. The goal is to see if it safely reduces skin symptoms like redness and scaling. Participants receive the drug or a placebo, and researchers monitor results over time. Since psoriasis is a chronic condition, treatment is meant to control it long-term, not cure it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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135 people
The number who actually took part.
- Started
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Jan 2020
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 years to 215 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 and/or phototherapy. * 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 Virus (HBV) test results, or hepatitis C virus (HCV) test result * Subjects who have a high risk of suicidality at the Screening assessment as indicated by the C-SSRS (Columbia Suicide Severity Rating Scale), or based on the Investigator's judgment. * Subject who has received any of the prohibited medications, supplements or substances during the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Site 1
Fountain Valley, California, 92708, United States
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Site 14
Spokane, Washington, 99202, United States
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Site 2
Thousand Oaks, California, 91320, United States
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Site 20
Miami, Florida, 33126, United States
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Site 39
Wroclaw, 51-503, Poland
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Site 41
Barcelona, 08041, Spain
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Site 47
Las Palmas de Gran Canaria, 35019, Spain
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Site 50
Ostrowiec Świętokrzyski, 27-400, Poland
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Site 51
Katowice, 40-611, Poland
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Site 52
Szczecin, 70-332, Poland
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Site 53
Warsaw, 02-507, Poland
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Site 54
Lodz, 90-265, Poland
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Site 56
Lodz, 90-436, Poland
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Site 57
Bialystok, 15-453, Poland
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Site 58
Lublin, 20-573, Poland
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Site 59
Sosnowiec, 41-200, Poland
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Site 61
Debrecen, H-4032, Hungary
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Site 62
Budapest, H-1036, Hungary
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Site 63
Budapest, H-1033, Hungary
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Site 64
Kaposvár, H-7400, Hungary
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Site 7
Miami, Florida, 33173, United States
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Site 71
Lucknow, 226005, India
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Site 74
Surat, 395002, India
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Site 79
Ahmedabad, 380009, India
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Site 90
Trnava, 91775, Slovakia
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Site 91
Svidník, 8901, Slovakia
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Site 92
Bardejov, 8501, Slovakia
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