Status:
ACTIVE_NOT_RECRUITING
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
Detailed Description
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 with a positive pregnancy test.
- Female subjects who are pregnant or planning to become pregnant while on study through 5 weeks after receiving the dose of study drug.
Key Trial Info
Start Date :
January 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2029
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03240809
Start Date
January 24 2020
End Date
June 1 2029
Last Update
September 16 2025
Active Locations (5)
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1
Bausch Site 003
San Diego, California, United States, 92123
2
Bausch Site 002
Miami, Florida, United States, 33155
3
Bausch Site 004
Miami, Florida, United States, 33155
4
Bausch Site 005
Henderson, Nevada, United States, 89052