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

NCT03240809 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: V01-BROA-401
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• maximum observed concentration (Cmax)

  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

  29 Days

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Biological: Brodalumab

Cohort 2

EXPERIMENTAL

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

Biological: Brodalumab

Interventions

Brodalumab BIOLOGICAL

140 mg SC dose

Cohort 1

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (5)

Bausch Site 003

San Diego, California, 92123, United States

Location

Bausch Site 002

Miami, Florida, 33155, United States

Location

Bausch Site 004

Miami, Florida, 33155, United States

Location

Bausch Site 005

Henderson, Nevada, 89052, United States

Location

Bausch Site 001

Las Vegas, Nevada, 45242, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Varsha Bhatt

  Bausch Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: January 24, 2020
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (5)