NCT03240809

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Brodalumab	140 mg SC dose
BIOLOGICAL	Brodalumab	70 mg SC dose

Timeline

• Start date: 2020-01-24
• Primary completion: 2028-12-01
• Completion: 2029-06-01
• First posted: 2017-08-07
• Last updated: 2025-09-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study