Pityriasis Rubra Pilaris
Conditions
Brief summary
The purpose of this study is to valuate the clinical efficacy of Bimzelx therapy in adults with Pityriasis Rubra Pilaris.
Interventions
DRUGBimekizumab
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical and/or histopathological diagnosis of PRP * Candidate for systemic therapy (PASI ≥ 10) * Body surface area of involvement ≥ 10% * Good general health as confirmed by medical history * Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and * Patients who read and sign an approved informed consent for this study
Exclusion criteria
* Vulnerable study population * Pregnant or nursing women * Women planning a pregnancy within the study period * Human immunodeficiency virus (HIV) positivity * Known history of adverse reaction to Bimzelx * Known history of hepatitis B, hepatitis C, or tuberculosis * Personal or family history of inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with ≥ 75% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 24 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dermatology Life Quality Index (DLQI) score | Baseline, 28 weeks | 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 |
| Number of patients with ≥ 90% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 28 weeks | 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). |
| Change in Physician Global Assessment (PGA) score | Baseline, 28 weeks | The Physician Global Assessment (PGA) is a clinician-reported 5 point scale 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) |
Countries
United States
Contacts
CONTACTReagan Dukes
PRINCIPAL_INVESTIGATORJason C. Sluzevich, MD
Mayo Clinic
Outcome results
None listed