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

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

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

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Brodalumab; Biological: Brodalumab

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 Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sandra Narain; Phone Number: 908.242.8287; Email: sandra.narain@bauschhealth.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Bausch Site 003
  • Florida
    • Miami, Florida, United States, 33155
      • Recruiting
      • Bausch Site 002
    • Miami, Florida, United States, 33155
      • Recruiting
      • Bausch Site 004
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Recruiting
      • Bausch Site 005
    • Las Vegas, Nevada, United States, 45242
      • Recruiting
      • Bausch Site 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; (ages 12 to <18 years): 140 mg SC dose of brodalumab	Biological: Brodalumab; 140 mg SC dose; Biological: Brodalumab; 70 mg SC dose
Experimental: Cohort 2; (ages 6 to <12 years): 70 mg SC dose of brodalumab	Biological: Brodalumab; 140 mg SC dose; Biological: Brodalumab; 70 mg SC dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Varsha Bhatt, Bausch Health

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Dermatologic Agents; Antibodies, Monoclonal; Brodalumab
• Other Study ID Numbers: V01-BROA-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No