NCT04533737

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

Efficacy and Safety Comparison of Brodalumab Versus Guselkumab in Adult Subjects With Moderate-to-severe Plaque Psoriasis and Inadequate Response to Ustekinumab

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.

Detailed description

Brodalumab is an anti-interleukin 17 receptor A antibody (IL-17RA) and blocks the inflammatory effects of different IL-17 cytokines (IL-17A, IL-17C, IL-17F, IL-17A/F heterodimer, and IL-17E) in the skin. With increasing availability of novel biologics with new targets, the complexity of choosing the appropriate biologic treatment is ever more challenging for physicians. Therefore, the primary objective of this trial is to compare the efficacy of brodalumab versus guselkumab in adult participants with moderate to severe plaque psoriasis and inadequate response to ustekinumab, thereby providing new scientific information that could support decision making in the clinical setting. The study will run approximately 32 weeks for each participant (including a 2- to 4-weeks screening period and a 28-week treatment period), with the primary endpoint measurement at Week 16. Participants receive subcutaneous injections of brodalumab or guselkumab. Dummy injections are also given, so participants and assessors are unaware of which treatment is given.

Conditions

• Plaque Psoriasis
• Psoriasis Vulgaris
• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Brodalumab	Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection
OTHER	Placebo	The placebo solution is similar to the active guselkumab (Dummy 1) or brodalumab (Dummy 2) solution except that it does not contain any active substance
BIOLOGICAL	Guselkumab	Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection

Timeline

• Start date: 2020-12-17
• Primary completion: 2022-09-08
• Completion: 2022-12-07
• First posted: 2020-09-01
• Last updated: 2025-03-14
• Results posted: 2024-01-09

Locations

65 sites across 12 countries: Austria, Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study