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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03240809
• Other study ID #: V01-BROA-401
• Status: Recruiting
• Phase: Phase 4
• Start date: January 24, 2020
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Bausch Health Americas, Inc.
• Contact: Sandra Narain
• Phone: 908.242.8287
• Email: sandra.narain[@]bauschhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Brodalumab
140 mg SC dose
• Brodalumab
70 mg SC dose

Locations

Country	Name	City	State
United States	Bausch Site 005	Henderson	Nevada
United States	Bausch Site 001	Las Vegas	Nevada
United States	Bausch Site 002	Miami	Florida
United States	Bausch Site 004	Miami	Florida
United States	Bausch Site 003	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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