NCT04306315

Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

Adjustable Brodalumab Dosage Regimen Compared With Standard Brodalumab Treatment for 52 Weeks in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo.

Detailed description

Brodalumab is an anti-IL-17 receptor antibody and blocks the inflammatory effects of IL-17 in the skin. Some psoriasis patients with a higher body weight experienced a lower treatment effect of brodalumab in clinical studies. Therefore, the purpose of this study is to investigate if increasing the dose of brodalumab will increase the effect of treatment for patients with a higher body weight. The study will run over 60-62 weeks, including screening, treatment period and safety follow-up, with the primary endpoint measurement at Week 40. Patients will receive subcutaneous injections of brodalumab at Week 0, 1, and 2, followed by injections every 2 weeks. Participants not fulfilling a predefined response at any time after Week 16 will receive a dose adjustment to 280 mg brodalumab or 210 mg brodalumab plus placebo every 2 weeks.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
BIOLOGICAL	Brodalumab	Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.

Timeline

• Start date: 2022-08-16
• Primary completion: 2025-08-25
• Completion: 2026-01-05
• First posted: 2020-03-12
• Last updated: 2026-01-08

Locations

81 sites across 11 countries: Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study