New hope for kids with severe psoriasis: drug trial underway
NCT ID NCT04123795
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 3 times
Summary
This study tests a drug called certolizumab pegol (Cimzia) in children aged 6 to 17 with moderate to severe plaque psoriasis. The goal is to see how the drug moves through the body and whether it is safe. Some children will get the drug, others a placebo. The study is active but no longer recruiting new participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- certolizumab pegol (Cimzia)
- What this could lead to
- If successful, this could provide a new treatment option for children with moderate to severe plaque psoriasis, helping to clear skin and reduce symptoms.
- What could go wrong
- This is a relatively small study (49 participants) focused on drug levels and safety, not yet proving effectiveness. As with any immune-suppressing drug, there are risks of serious infections and allergic reactions.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
49 people
The number who actually took part.
- Started
-
Jan 2020
- Finished
-
Jul 2026
- 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 to 17 years
- 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 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: * Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and: 1. Body Surface Area (BSA) affected by psoriasis ≥10 % 2. Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4) 3. Psoriasis Area and Severity Index (PASI) score is ≥12 or 4. PASI score is ≥10 and \<12 with at least one of the following: * \>Clinically relevant facial or scalp involvement * \>Clinically relevant genital involvement * \>Clinically relevant palm and sole involvement * \>Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with \>50 % to \<80 % guttate lesions for ≥3 months, and must meet the same criteria listed above * Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy Exclusion Criteria: * Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP) * Study participant has generalized pustular or erythrodermic psoriasis (PSO) * Study participant has guttate PSO without plaque PSO * Study participant has had a primary failure to an anti-tumor necrosis factor agent * Study participant has had prior exposure to \>2 biologic therapies * Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening
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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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Ps0007 50156
Arlington, Texas, 76011, United States
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Ps0007 50161
Los Angeles, California, 90045, United States
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Ps0007 50162
Fountain Valley, California, 92708, United States
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Ps0007 50168
Chicago, Illinois, 60611, United States
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Ps0007 50169
Jacksonville, Florida, 32256, United States
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Ps0007 50175
Phoenix, Arizona, 85006, United States
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Ps0007 50183
Calgary, Canada
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Ps0007 50187
Edmonton, Canada
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Ps0007 50196
Thousand Oaks, California, 91320, United States
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Ps0007 50217
Boca Raton, Florida, 33428, United States
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Ps0007 50225
Calgary, Canada
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Ps0007 50230
Rome, Georgia, 30161, United States
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Ps0007 50232
Detroit, Michigan, 48202, United States
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Ps0007 50248
Hialeah, Florida, 33016, United States
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Ps0007 50265
San Juan, Puerto Rico
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Ps0007 50268
Miami, Florida, 33155, United States
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Ps0007 50269
Wellington, Florida, 33449, United States
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Ps0007 50277
San Antonio, Texas, 78218, United States
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Ps0007 50286
Topeka, Kansas, 66614, United States