An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
Phase 4
Recruiting
- Conditions
- Psoriasis
- Interventions
- Biological: Brodalumab
- Registration Number
- NCT03240809
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Brodalumab (ages 6 to \<12 years): 70 mg SC dose of brodalumab Cohort 1 Brodalumab (ages 12 to \<18 years): 140 mg SC dose of brodalumab
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Bausch Site 005
🇺🇸Henderson, Nevada, United States
Bausch Site 003
🇺🇸San Diego, California, United States
Bausch Site 002
🇺🇸Miami, Florida, United States
Bausch Site 004
🇺🇸Miami, Florida, United States
Bausch Site 001
🇺🇸Las Vegas, Nevada, United States