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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
| Psoriasis Treatment Center of Central New Jersey | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with moderate-to-severe psoriasis | Experimental | Individuals with moderate-to-severe psoriasis who have failed similar therapies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Surface Area (BSA) of < 1 | 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. | Baseline, Week 4, Week 8, Week 12, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis and Severity Index Score (PASI) of < 1 | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Lebwohl, MD | Ichan School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States | ||
Results will be provided as aggregated data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 21, 2025 | Apr 10, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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| Baseline, Week 4, Week 8, Week 12, Week 16 |
| Physician Global Assessment (PGA) of < 1 | 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. | Baseline, Week 4, Week 8, Week 12, Week 16 |
| Psoriasis and Severity Index Score (PASI) of < 2 | 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. | Baseline, Week 4, Week 8, Week 12, Week 16 |
| Physician Global Assessment (PGA) of < 2 | 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. | Baseline, Week 4, Week 8, Week 12, Week 16 |
| Icahn School of Medicine at Mount Sinai |
| New York |
| New York |
| 10029 |
| United States |