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NCT Number: NCT07497620

Bimzelx (Bimekizumab) For The Treatment Of Adult Onset PRP

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

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Key information

Conditions

Pityriasis Rubra Pilaris Pityriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Bimzelx

Primary outcomes

  1. Number of patients with ≥ 75% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 24 weeks

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. Change in Physician Global Assessment (PGA) score

    Time frame: Baseline, 28 weeks

    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)

  3. Change in Dermatology Life Quality Index (DLQI) score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Reagan Dukes

CONTACT

[email protected]

904-953-5144

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open?Label, Exploratory Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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