Bimekizumab in Plaque Psoriasis
- Registration Number
- NCT06336343
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Individuals with moderate-to-severe psoriasis Bimekizumab Individuals with moderate-to-severe psoriasis who have failed similar therapies.
- Primary Outcome Measures
Name Time Method Body Surface Area (BSA) of < 1 Baseline, Week 4, Week 8, Week 12, Week 16 Body Surface Area (BSA) \< 1 describes psoriasis affecting less than 1 percent of the body's surface. One hand covers roughly 1% of the body's surface area. Psoriasis affecting less than 3 percent BSA may be considered mild, 3 to 10 percent as moderate and more than 10 percent as severe.
- Secondary Outcome Measures
Name Time Method Physician Global Assessment (PGA) of < 1 Baseline, Week 4, Week 8, Week 12, Week 16 The Physician Global Assessment (PGA) is a severity assessment tool used to evaluate the overall lesional and non-lesional manifestations of psoriasis. PGA \< 1 indicates almost clear to clear psoriasis, based on physical attributes of the lesional and non-lesional manifestations. It means there is no signs of psoriasis or normal to pink coloration, no thickening, and no to minimal scaling. The full PGA score ranges from 0 (clear) to 5 (severe disease), with higher scores indicating more severe psoriasis.
Psoriasis and Severity Index Score (PASI) of < 1 Baseline, Week 4, Week 8, Week 12, Week 16 The Psoriasis Area and Severity Index (PASI) measures psoriasis severity. PASI \< 1 indicates almost clear to no psoriasis, based on skin area affected, erythema, induration, and desquamation. The full score ranges from 0 to 72, with higher scores indicating more severe psoriasis. Each body region (head, trunk, arms, legs) is scored 0 (no disease) to 6 (maximum score) for affected area and 0 (mild) to 4 (very severe) for erythema, induration, and desquamation. Higher scores indicate more severe psoriasis with a score of ≥10 generally defining moderate to severe disease.
Psoriasis and Severity Index Score (PASI) of < 2 Baseline, Week 4, Week 8, Week 12, Week 16 The Psoriasis Area and Severity Index (PASI) measures psoriasis severity. PASI \< 2 indicates almost clear to no psoriasis, based on skin area affected, erythema, induration, and desquamation. The full score ranges from 0 to 72, with higher scores indicating more severe psoriasis. Each body region (head, trunk, arms, legs) is scored 0 (no disease) to 6 (maximum score) for affected area and 0 (mild) to 4 (very severe) for erythema, induration, and desquamation. Higher scores indicate more severe psoriasis with a score of ≥10 generally defining moderate to severe disease.
Physician Global Assessment (PGA) of < 2 Baseline, Week 4, Week 8, Week 12, Week 16 The Physician Global Assessment (PGA) is a severity assessment tool used to evaluate the overall lesional and non-lesional manifestations of psoriasis. PGA \< 2 indicates almost clear to clear psoriasis, based on physical attributes of the lesional and non-lesional manifestations. It means there is no signs of psoriasis or normal to pink coloration, no thickening, and no to minimal scaling. The full PGA score ranges from 0 (clear) to 5 (severe disease), with higher scores indicating more severe psoriasis.
Trial Locations
- Locations (2)
Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States