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Active, not recruiting Phase 4

An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects

NCT03240809 · tracked via the Priya Life Science USA tracker
Phase
Phase 4
Started
2020-01-24
Last updated
2025-09-16

Condition(s) studied

Psoriasis

Investigational drug(s) / intervention(s)

Brodalumab →Brodalumab →

Brodalumab: 140 mg SC dose

Brodalumab: 70 mg SC dose

Study summary

An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • maximum observed concentration (Cmax) — 29 Days
    maximum (or peak) serum concentration that drug achieves in the body after drug has been administrated and prior to the administration of a second dose

Trial sites (5)

FacilityCityRegionStatus
Bausch Site 003 San Diego California
Bausch Site 002 Miami Florida
Bausch Site 004 Miami Florida
Bausch Site 005 Henderson Nevada
Bausch Site 001 Las Vegas Nevada
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03240809 on ClinicalTrials.gov ↗ ← All trials in the USA