An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
Study Details
Study Description
Brief Summary
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 (ages 12 to <18 years): 140 mg SC dose of brodalumab |
Biological: Brodalumab
140 mg SC dose
|
| Experimental: Cohort 2 (ages 6 to <12 years): 70 mg SC dose of brodalumab |
Biological: Brodalumab
70 mg SC dose
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Bausch Site 001 | Las Vegas | Nevada | United States | 45242 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: Anya Loncaric, Bausch Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V01-BROA-401