NCT04305327

Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis

A Phase 3, Randomised, Double-blind, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Brodalumab Treatment Compared to Placebo and Ustekinumab in Adolescent Subjects With Moderate-to-severe Plaque Psoriasis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate the efficacy and safety compared to placebo and the safety compared to ustekinumab of brodalumab in adolescents with moderate to severe plaque psoriasis. The study will also investigate if brodalumab affects development of vaccination-induced immune responses. The study will run over 62-64 weeks (including screening, treatment, and safety follow-up) for each participant, but with the primary endpoint measured at Week 12.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Brodalumab	Solution for subcutaneous injection.
DRUG	Ustekinumab	Solution for subcutaneous injection.
DRUG	Placebo	The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.

Timeline

• Start date: 2022-12-07
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2020-03-12
• Last updated: 2025-03-14
• Results posted: 2024-02-28

Locations

35 sites across 8 countries: Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study