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

Bausch Health

Status and phase: Active, not recruiting; Phase 4

Conditions: Psoriasis

Treatments: Biological: Brodalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03240809

V01-BROA-401

Details and patient eligibility

About

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

Full 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

Enrollment: 2 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Cohort 1

Experimental group

Description:

(ages 12 to \<18 years): 140 mg SC dose of brodalumab

Treatment:

Biological: Brodalumab

Biological: Brodalumab

Cohort 2

Experimental group

Description:

(ages 6 to \<12 years): 70 mg SC dose of brodalumab

Treatment:

Biological: Brodalumab

Biological: Brodalumab