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New hope for kids with severe psoriasis: drug trial shows promise

NCT ID NCT03997786

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

135 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

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

6 years to 215 months

Sex

Anyone

Healthy volunteers

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

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

  • Site 1

    Fountain Valley, California, 92708, United States

  • Site 14

    Spokane, Washington, 99202, United States

  • Site 2

    Thousand Oaks, California, 91320, United States

  • Site 20

    Miami, Florida, 33126, United States

  • Site 39

    Wroclaw, 51-503, Poland

  • Site 41

    Barcelona, 08041, Spain

  • Site 47

    Las Palmas de Gran Canaria, 35019, Spain

  • Site 50

    Ostrowiec Świętokrzyski, 27-400, Poland

  • Site 51

    Katowice, 40-611, Poland

  • Site 52

    Szczecin, 70-332, Poland

  • Site 53

    Warsaw, 02-507, Poland

  • Site 54

    Lodz, 90-265, Poland

  • Site 56

    Lodz, 90-436, Poland

  • Site 57

    Bialystok, 15-453, Poland

  • Site 58

    Lublin, 20-573, Poland

  • Site 59

    Sosnowiec, 41-200, Poland

  • Site 61

    Debrecen, H-4032, Hungary

  • Site 62

    Budapest, H-1036, Hungary

  • Site 63

    Budapest, H-1033, Hungary

  • Site 64

    Kaposvár, H-7400, Hungary

  • Site 7

    Miami, Florida, 33173, United States

  • Site 71

    Lucknow, 226005, India

  • Site 74

    Surat, 395002, India

  • Site 79

    Ahmedabad, 380009, India

  • Site 90

    Trnava, 91775, Slovakia

  • Site 91

    Svidník, 8901, Slovakia

  • Site 92

    Bardejov, 8501, Slovakia

More trials for these conditions

Other studies related to the condition(s) this trial covers.