Bimzelx (Bimekizumab) For The Treatment Of Adult Onset PRP

NCT07497620 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-010763
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pityriasis Rubra Pilaris

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

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

  28 weeks

• Change in Physician Global Assessment (PGA) score

  Baseline, 28 weeks

• Change in Dermatology Life Quality Index (DLQI) score

  Baseline, 28 weeks

Study Arms (1)

Bimzelx

EXPERIMENTAL

Patients will be treated with Bimzelx for pityriasis rubra pilaris, 320 mg, by subcutaneous injection.

Drug: Bimekizumab

Interventions

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.

Also known as: Bimzelx

Bimzelx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pityriasis Rubra Pilaris

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Pityriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jason C. Sluzevich, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reagan Dukes

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)