Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris

Study Overview
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Brief Summary
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The primary objective of this study is to assess the potential effectiveness of Cosentyx in the treatment of adult-onset Pityriasis Rubra Pilaris or PRP.

Official Title
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Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open-label Exploratory Trial

Conditions
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PITYRIASIS RUBRA PILARIS

Intervention / Treatment
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* Drug: Cosentyx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Informed subject consent will be obtained from those patients meeting the following inclusion criteria: Male and female patients 18 years or older. 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 Patients are to be excluded based on the following 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 Cosentyx Known history of hepatitis B, hepatitis C, or tuberculosis Personal or family history of inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Cosentyx (Secukinumab) for the treatment of adult onset pityriasis rubra pilaris
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Patients with a biopsy proven diagnosis of PRP | Drug: Cosentyx<br>* Cosentyx 300 mg SQ week 0-4, then every q4 weeks for a total of 28 weeks.<br>* Other names: Secukinumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI-75 | Psoriasis Area and Severity Index (PASI)-75 response rate: the number of study participants with a PASI percent improvement from baseline of ≥ 75%. As no formalized disease severity assessment scoring exists for PRP, the PASI score was selected given the phenotypic overlap between psoriasis and PRP | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI-90 | PASI-90 response rate: the number of study participants with a PASI percent improvement from baseline of ≥ 90% | 28 weeks | 
| DLQI | Dermatology Quality of Life Index - mean change before and after treatment | 28 weeks | 
| PGA | Physician Global assessment - mean change before and after treatment | 28 weeks |