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The purpose of this study is to valuate the clinical efficacy of Bimzelx therapy in adults with Pityriasis Rubra Pilaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimzelx | Experimental | Patients will be treated with Bimzelx for pityriasis rubra pilaris, 320 mg, by subcutaneous injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Subjects will receive subcutaneous injection of 320 mg at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter for 24 weeks. For patients weighing ≥ 120 kg, 320 mg every 4 weeks after Week 16, for 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with ≥ 75% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 24 weeks | The Psoriasis Area and Severity Index (PASI) is a measure of disease activity assessed using the degree of body surface area involvement, the severity of lesions, and assessment of lesional erythema, induration, and scaling. These calculations are combined into a single score that ranges from 0 (no skin disease) to 72 (near complete skin involvement). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with ≥ 90% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 28 weeks | The Psoriasis Area and Severity Index (PASI) is a measure of disease activity assessed using the degree of body surface area involvement, the severity of lesions, and assessment of lesional erythema, induration, and scaling. These calculations are combined into a single score that ranges from 0 (no skin disease) to 72 (near complete skin involvement). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reagan Dukes | Contact | 904-953-5144 | dukes.reagan@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason C. Sluzevich, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D010916 | Pityriasis Rubra Pilaris |
| ID | Term |
|---|---|
| D010915 | Pityriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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|
| 28 weeks |
| Change in Physician Global Assessment (PGA) score | The Physician Global Assessment (PGA) is a clinician-reported 5 point sacle used to evaluate overall disease activity. Ratings range from 0=clear (no signs of PRP, post-inflammatory pigmentation may be present); 1=almost clear (minimal plaque elevation, scaling or erythema); 2 =mild (slight plaque elevation, scaling, erythema); 3=moderate (moderate plaque elevation, scaling, and erythema); 4 =severe (very marked plaque elevation, scaling, and erythema) | Baseline, 28 weeks |
| Change in Dermatology Life Quality Index (DLQI) score | The Dermatology Life Quality Index (DLQI) consists of 10 standardized items measuring impact of skin disease rated as 0=not at all/not relevant; 1=a little; 2=a lot; 3=very much | Baseline, 28 weeks |