Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris (PRP)

Phase 4Not Yet RecruitingNCT07497620

Mayo Clinic12 enrolled

Overview

The purpose of this study is to valuate the clinical efficacy of Bimzelx therapy in adults with Pityriasis Rubra Pilaris.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pityriasis Rubra Pilaris

Interventions

BimekizumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: 24 weeks

Secondary Outcomes

Number of patients with ≥ 90% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 28 weeks

Time frame: 28 weeks

Change in Physician Global Assessment (PGA) score

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)

Time frame: 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

Time frame: Baseline, 28 weeks

Central Contacts

Reagan Dukes

CONTACT

904-953-5144 dukes.reagan@mayo.edu

Data from ClinicalTrials.gov

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