Deucravacitinib for Pityriasis Rubra Pilaris

Overseen By Hannah Samuel Gnanadas

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: TYK2 inhibitors

Disqualifiers: HIV, Hepatitis B, Hepatitis C, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Deucravacitinib (also known as Sotyktu or BMS-986165) for individuals with Pityriasis Rubra Pilaris (PRP). The goal is to assess the safety and effectiveness of this treatment in improving symptoms like skin redness and scaling over 24 weeks. Researchers aim to identify unique skin markers that might predict treatment response. This trial may suit those with moderate to severe PRP who have not found success with or are unsuitable for topical treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that ongoing use of any treatment prohibited by the protocol is not allowed. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that Deucravacitinib is likely to be safe for humans?

Research shows that Deucravacitinib is safe and generally well-tolerated. In earlier studies for treating moderate-to-severe plaque psoriasis, Deucravacitinib consistently demonstrated safety over five years. Most patients experienced only mild or moderate side effects, such as headaches or respiratory infections. This medication is already approved for another condition, indicating thorough safety testing. While the current study focuses on its safety for Pityriasis Rubra Pilaris, previous data support its strong safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Pityriasis Rubra Pilaris?

Deucravacitinib is unique because it targets a specific enzyme called TYK2, which plays a critical role in the inflammatory pathways associated with Pityriasis Rubra Pilaris. Unlike standard treatments, which often include topical steroids or systemic therapies like methotrexate that can affect the entire immune system, Deucravacitinib offers a more targeted approach. Researchers are excited about this treatment because it has the potential to be more effective with fewer side effects, offering a promising alternative for those who haven't seen results with existing options.

What evidence suggests that Deucravacitinib might be an effective treatment for Pityriasis Rubra Pilaris?

Research has shown that Deucravacitinib, which participants in this trial will receive, offers promising results for conditions like Pityriasis Rubra Pilaris. In earlier studies on psoriasis, a skin condition with some similarities, Deucravacitinib led to a 75% or greater reduction in symptoms for many patients. This improvement was measured using the Psoriasis Area and Severity Index (PASI). These results suggest that the treatment effectively reduces skin symptoms. While specific data for Pityriasis Rubra Pilaris is still being gathered, these findings provide hope that Deucravacitinib could also be effective for this condition. ^{1 2 6 7 8}

Who Is on the Research Team?

Aaron Mangold

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Pityriasis Rubra Pilaris, a skin condition causing red scaly patches. Participants should be diagnosed with this condition and willing to undergo treatment assessments. Specific eligibility details are not provided but typically include age, health status, and no conflicting medications or treatments.

Inclusion Criteria

Inadequate response to or not suitable for topical therapy in the opinion of the investigator.

Written informed consent must be obtained before any assessment is performed.

Biopsy result consistent with PRP and not diagnostic for another disease.

Exclusion Criteria

I do not have any skin conditions that could interfere with the study.

Current, severe, progressive or uncontrolled diseases that render the patient unsuitable for the trial, including any medical or psychiatric condition that, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.

Pregnant or nursing (lactating) women.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Deucravacitinib, twice daily for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview

The study tests Deucravacitinib's safety and effectiveness on skin symptoms by measuring changes in the severity of the disease using scales like IGA and PASI scores, quality of life (DLQI), itchiness (NRS itch), and Skindex-16 at week 24. It also aims to find biomarkers predicting treatment response.

How Is the Trial Designed?

Group I: Pityriasis Rubra Pilaris Experimental Treatment 1 Intervention

Subjects will receive Deucravacitinib, twice daily for 24 weeks

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A patient with resistant pityriasis rubra pilaris showed significant improvement when treated with a combination of acitretin and ustekinumab, suggesting this dual therapy may be effective for difficult cases.

This case highlights the potential benefits of using a combination treatment approach for patients who do not respond to standard therapies for pityriasis rubra pilaris.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of resistant pityriasis ribra pilaris responsive to combination acitrentin and ustekinumab. Cook, E., Tran, KW., Kollipara, S., et al.[2020]

Calcipotriol, a treatment known for psoriasis, was found to be effective in three patients with pityriasis rubra pilaris, suggesting it may be a viable option for this condition as well.

In one patient, treatment with calcipotriol led to a decrease in inflammatory markers and immune cell presence, but unlike psoriasis, there was no reduction in the recruitment of cycling epidermal cells, indicating different underlying mechanisms in these skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical treatment of pityriasis rubra pilaris with calcipotriol. Van de Kerkhof, PC., Steijlen, PM.[2019]

A 70-year-old man developed symptoms of pityriasis rubra pilaris, a rare inflammatory skin disorder, just 10 days after receiving an intravitreal injection of bevacizumab, a medication commonly used for age-related macular degeneration.

This case highlights the potential for rare skin reactions associated with immune-modulating drugs like bevacizumab, emphasizing the need for awareness of such complications in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab-induced pityriasis rubra pilaris-like eruption. Brown, S., Fletcher, JW., Fiala, KH.[2020]

A systematic review of 182 studies involving 475 patients found that retinoids, particularly isotretinoin, had the highest excellent response rate (61.1%) for treating pityriasis rubra pilaris (PRP), compared to 33.1% for methotrexate.

Biological treatments also showed promising results, with a success rate of 51.0%, suggesting that isotretinoin should be considered as the first-line treatment, followed by methotrexate and biologicals for managing this challenging skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic therapies of pityriasis rubra pilaris: a systematic review. Kromer, C., Sabat, R., Celis, D., et al.[2020]

Pityriasis rubra pilaris is a rare skin condition that often does not respond well to standard treatments like oral retinoids and topical corticosteroids, highlighting the need for effective alternatives.

In a reported case, treatment with upadacitinib, a Janus kinase inhibitor, showed a favorable response in managing pityriasis rubra pilaris, suggesting it may be a promising new option for patients with this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pityriasis rubra pilaris partially responsive to treatment with upadacitinib: A case report. Saad, M., Spurr, A., Lipson, J.[2023]

In a study of 45 patients with pityriasis rubra pilaris, treatment with oral 13-cis-retinoic acid (isotretinoin) led to significant improvements in skin symptoms such as redness and scaling within just 4 weeks.

Many patients experienced sustained remission or continued improvement even after stopping the medication, highlighting isotretinoin's potential as an effective treatment option for this challenging skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pityriasis rubra pilaris response to 13-cis-retinoic acid (isotretinoin). Goldsmith, LA., Weinrich, AE., Shupack, J.[2019]

Pityriasis rubra pilaris is a rare skin condition characterized by symptoms like follicular papules and palmoplantar keratoderma, often triggered by trauma or infection in predisposed individuals, with unclear causes.

Oral retinoids have shown the best therapeutic results for this condition, while new treatments involving anti-tumor necrosis factor and anti-interleukin-12/23 antibodies are emerging as potential options, although clinical trials are lacking due to the disease's rarity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pityriasis rubra pilaris]. Quenan, S., Laffitte, E.[2018]

A 60-year-old woman developed a pityriasis rubra pilaris (PRP)-like eruption after starting treatment with ponatinib, a tyrosine kinase inhibitor, 6 weeks prior, highlighting a potential side effect of this medication.

Treatment with local corticosteroids successfully resolved the eruption, suggesting that while the response to topical treatments can vary, corticosteroids may be effective for managing TKI-induced skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new case of pityriasis rubra pilaris-like eruption associated with ponatinib, a tyrosine kinase inhibitor]. Krygier, J., Leemans, G., Forsyth, R., et al.[2019]

Ponatinib, a third-generation tyrosine kinase inhibitor for chronic myeloid leukemia and Philadelphia-positive acute lymphoblastic leukemia, commonly causes cutaneous toxicities, particularly rashes, with specific subtypes like pityriasis rubra pilaris-like eruptions being less frequently reported.

The study presents two cases of ponatinib-induced pityriasis rubra pilaris-like eruptions and reviews the clinical and histopathologic features of all known ponatinib-associated skin eruptions, highlighting the importance of recognizing these side effects for proper diagnosis and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ponatinib-Associated Cutaneous Eruptions-A Case Series and Review of Clinicopathologic Findings. Weber, I., Gloss, C., Castillo, B., et al.[2022]

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Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris

Study Goals. The primary goal of this study is to evaluate the safety and effectiveness of Deucravacitinib (BMS-986165) in treating Pityriasis Rubra Pilaris.