NCT06336343

Bimekizumab in Plaque Psoriasis

A Study to Evaluate the Safety and Efficacy of Bimekizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17 or IL-23 Therapies

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies. Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins (specifically, interleukins 17a and 17F), which are known to increase inflammation. This study will look at the effectiveness of bimekizumab in psoriasis patients that have failed previous therapies that target interleukin IL-17A or 23.

Detailed description

This study will evaluate the safety and efficacy of bimekizumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin (IL)-17 or 23 therapies. Failure of IL-17 and/or IL-23 therapy will be defined as previous treatment with either secukinumab, ixekizumab, brodalumab, tildrakizumab, guselkumab, or risankizumab for at least 3 months without achieving PASI90 and a BSA \>3%. Sixty patients will be enrolled in this 16-week open-label study. Patients will be enrolled at two different sites in the US. After enrollment, study visits will occur at monthly intervals, with patients receiving bimekizumab 320 mg via subcutaneous injection at weeks 0, 4, 8, 12 and 16. At each visit, patients will be evaluated for change in PGA (Physician's Global Assessment), PASI score, BSA and any signs or symptoms of adverse events. Laboratory screening will include tests for tuberculosis. The primary efficacy endpoint will be the percentage of patients achieving BSA \< 1 by week 16.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Bimekizumab	Bimekizumab 320 mg via subcutaneous injections. Bimekizumab is a humanized immunoglobulin G1 monoclonal antibody that selectively binds to and neutralizes the biologic functions of both interleukin-17A (IL-17A) and IL-17F, which are known to increase inflammation.

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-03-13
• Completion: 2026-03-13
• First posted: 2024-03-28
• Last updated: 2025-11-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study