New drug trial for kids with severe psoriasis shows promise
NCT ID NCT03240809
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a single dose of brodalumab in children aged 6 to 17 with severe plaque psoriasis. The goal is to see how safe the drug is and how the body processes it. Only 2 children are enrolled, making this a very early look at the drug's effects in younger patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brodalumab
- What this could lead to
- If successful, this could provide a treatment option for children with severe psoriasis, helping to control their symptoms.
- What could go wrong
- This is a very small, early-phase study with only 2 participants, so results may not apply to all children. The drug may cause side effects or not work as expected.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
2 people
The number who actually took part.
- Started
-
Jan 2020
- Expected to finish
-
Jun 2029
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 to 18 years
- Sex
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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: 1. Subject's parent(s) or legally acceptable representative has provided informed consent, using an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form (ICF), when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated, or when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent. 2. Males and females ages 6 to \<18 years of age, inclusive, at the time of screening 3. Subjects must have up-to-date immunizations according to the relevant local country guideline. Subjects must not be scheduled to be vaccinated while on study. 4. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test at Baseline (Day 1). A female of childbearing potential is defined as a female who is fertile, following menarche. Exclusion Criteria: 1. Received conventional systemic therapies or phototherapy for treatment of psoriasis within the last 4 weeks. Topical corticosteroids are allowed. 2. Female subjects who have reached puberty and are sexually active and are unwilling to use acceptable methods of effective birth control for the duration of the study and continuing for 5 weeks after receiving the dose of study drug. Acceptable methods of effective birth control include sexual abstinence (males and females); double barrier method (male condom with spermicide in combination with one female barrier method \[diaphragm, cervical cap, or contraceptive sponge)\]; or hormonal birth control; or intra-uterine device. 3. Female subjects who are lactating/breastfeeding or who plan to breastfeed while on study through 5 weeks after receiving the dose of study drug. 4. Female subjects with a positive pregnancy test. 5. Female subjects who are pregnant or planning to become pregnant while on study through 5 weeks after receiving the dose of study drug.
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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
-
Bausch Site 001
Las Vegas, Nevada, 45242, United States
-
Bausch Site 002
Miami, Florida, 33155, United States
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Bausch Site 003
San Diego, California, 92123, United States
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Bausch Site 004
Miami, Florida, 33155, United States
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Bausch Site 005
Henderson, Nevada, 89052, United States
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