NCT03240809Active, not recruitingPhase 4
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects (6 to < 18 Years Old) With Severe Plaque Psoriasis
Source: ClinicalTrials.gov · Last updated 16 Sept 2025
Brief summary (registry, in English)
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2 (actual)
- First submitted
- 2 Aug 2017
- Start date
- 24 Jan 2020
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Bausch Health Americas, Inc.
- Diseases
- Psoriasis
- NCT number
- NCT03240809
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 2
- From 24 Jan 2020 to the primary completion date, 31 Dec 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received conventional systemic therapies or phototherapy for treatment of psoriasis within the last 4 weeks. Topical corticosteroids are allowed.
- 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.
- Female subjects who are lactating/breastfeeding or who plan to breastfeed while on study through 5 weeks after receiving the dose of study drug.
- Female subjects who are pregnant or planning to become pregnant while on study through 5 weeks after receiving the dose of study drug.
Other
- Female subjects with a positive pregnancy test.
Who the study is looking for
- 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.
- Males and females ages 6 to \<18 years of age, inclusive, at the time of screening
- 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.
- 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.
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bausch Site 005 Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Bausch Site 001 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Bausch Site 004 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Bausch Site 002 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Bausch Site 003 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.