Not yet recruiting NCT07497620
Bimzelx (Bimekizumab) For The Treatment Of Adult Onset PRP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bimekizumab.
- Who it may be relevant to
- Registry conditions: Pityriasis Rubra Pilaris. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open?Label, Exploratory Trial
Overview
The purpose of this study is to valuate the clinical efficacy of Bimzelx therapy in adults with Pityriasis Rubra Pilaris.
Interventions
- Drug Bimekizumab
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.
Primary outcome measures
- Number of patients with ≥ 75% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 24 weeks [Time frame: 24 weeks]
Secondary outcome measures (3)
- 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 [Time frame: Baseline, 28 weeks]
- Change in Dermatology Life Quality Index (DLQI) score [Time frame: Baseline, 28 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT07497620 · 25-010763