Bimekizumab for Pityriasis Rubra Pilaris

Overseen By Reagan Dukes

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, HIV, Hepatitis, Tuberculosis, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Bimekizumab in treating Pityriasis Rubra Pilaris (PRP), a rare skin condition characterized by red, scaly patches. Participants will receive Bimekizumab injections to determine its impact on their skin condition. The trial seeks adults diagnosed with PRP who have significant skin involvement and are in good general health. Participants must also agree to follow the study's requirements and provide consent. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand how Bimekizumab benefits more patients with PRP.

What is the safety track record for Bimekizumab?

Research has shown that bimekizumab is well-tolerated by people with psoriasis, a condition similar to pityriasis rubra pilaris (PRP). In studies involving individuals with psoriasis, many maintained clear skin for three years without major safety issues. One study found that out of 153 patients, a large number experienced significant skin improvement without serious side effects over five years.

Additionally, a safety review using FDA data identified 2,780 reports and 70 potential safety concerns, which are under close observation. While bimekizumab has a strong safety record, ongoing monitoring remains crucial to manage any risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for pityriasis rubra pilaris, which often include topical therapies or systemic retinoids, Bimekizumab offers a novel approach by targeting specific inflammatory pathways. This drug is unique because it blocks both IL-17A and IL-17F, two proteins involved in inflammation, providing a more comprehensive reduction of symptoms. Researchers are excited about Bimekizumab because this dual inhibition could lead to better skin clearance and longer-lasting results compared to current options. Additionally, its administration via subcutaneous injection allows for convenient dosing that may improve patient compliance.

What is the effectiveness track record for Bimekizumab in treating Pityriasis Rubra Pilaris?

Research has shown that Bimekizumab may help treat pityriasis rubra pilaris (PRP), particularly for patients who haven't responded to other treatments. Some patients experienced symptom improvement with Bimekizumab when other medications failed. This drug blocks specific proteins that cause inflammation. Previous studies demonstrated its effectiveness for similar skin conditions like psoriasis, with many patients achieving clear skin after treatment. These findings suggest that Bimekizumab could be effective for PRP, offering hope to those dealing with this challenging condition. ^{1 2 3 5 6}

Who Is on the Research Team?

Jason C. Sluzevich, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing and able to follow all study instructions.

Patients who read and sign an approved informed consent for this study

My condition affects at least 10% of my body surface area.

Exclusion Criteria

Human immunodeficiency virus (HIV) positivity

Vulnerable study population

Pregnant or nursing women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Bimzelx therapy for Pityriasis Rubra Pilaris via subcutaneous injection

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bimekizumab

How Is the Trial Designed?

Group I: Bimzelx Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12339111/

Efficacy of Bimekizumab in the Management of Refractory ...

To date, two published cases have reported successful PRP treatment with bimekizumab [5,6]. Unlike these cases, where longer disease duration may have ...

2.

skin.dermsquared.com

skin.dermsquared.com/skin/article/view/2980

Pityriasis Rubra Pilaris, Refractory to IL-17A Inhibition, with ...

Bimekizumab may offer improved efficacy for the treatment of pityriasis rubra pilaris (PRP) in patients who do not respond to other therapies.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07497620

Bimzelx (Bimekizumab) For The Treatment Of Adult Onset ...

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

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/ddg.15252

Bimekizumab in refractory pityriasis rubra pilaris

Thus, our case provides evidence that the simultaneous inhibition of IL-17A and IL-17F by bimekizumab may be effective in PRP, but larger ...

5.

bimzelxhcp.com

bimzelxhcp.com/rheumatology/PSO-Data

Efficacy in Moderate-to-Severe Plaque Psoriasis

The BE SURE trial showed that at Week 16, PASI 90 and PASI 100 were reached by 86% and 61% of BIMZELX patients vs 47% and 24% of patients receiving adalimumab, ...

6.

docwirenews.com

docwirenews.com/post/pooled-bimekizumab-data-across-five-phase-three-psoriasis-trials

Bimekizumab for Psoriasis | Docwire ...

April Armstrong, MD, MPH, describes results from a pooled analysis of 3-year data on bimekizumab for psoriasis.