Evaluating Brodalumab for treating severe psoriasis in children

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

This study is testing a single dose of Brodalumab to see how safe it is and how well it works for children aged 6 to under 18 with severe psoriasis.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 6 Years to 18 Years
• Sex: All
• Sponsor: Bausch Health Americas, Inc. (Industry-sponsored)
• Drugs / interventions: Brodalumab
• Locations: 5 sites (San Diego, California and 4 other locations)
• Trial ID: NCT03240809 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of a single dose of Brodalumab in pediatric patients aged 6 to less than 18 years with severe plaque psoriasis. The open-label design allows for direct observation of the drug's effects without a control group. Participants will receive the medication and be monitored for any adverse reactions and how their bodies process the drug. The study aims to gather important data that could inform future treatments for this condition in children.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to less than 18 years with a diagnosis of severe plaque psoriasis.

Not a fit: Patients with mild psoriasis or those who are not within the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for children suffering from severe psoriasis.

How similar studies have performed: While there have been studies on Brodalumab in adults, this specific evaluation in pediatric patients is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

San Diego, California and 4 other locations

• Bausch Site 003 — San Diego, California, United States (Recruiting)
• Bausch Site 002 — Miami, Florida, United States (Recruiting)
• Bausch Site 004 — Miami, Florida, United States (Recruiting)
• Bausch Site 005 — Henderson, Nevada, United States (Recruiting)
• Bausch Site 001 — Las Vegas, Nevada, United States (Recruiting)

Study contacts

• Study coordinator: Sandra Narain

Conditions Psoriasis