PITYRIASIS RUBRA PILARIS
Conditions
Brief summary
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.
Interventions
DRUGCosentyx
Cosentyx 300 mg SQ week 0-4, then every q4 weeks for a total of 28 weeks.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cosentyx (Secukinumab) for the treatment of adult onset pityriasis rubra pilaris
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PASI-75 | 28 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI-90 | 28 weeks | PASI-90 response rate: the number of study participants with a PASI percent improvement from baseline of ≥ 90% |
| DLQI | 28 weeks | Dermatology Quality of Life Index - mean change before and after treatment |
| PGA | 28 weeks | Physician Global assessment - mean change before and after treatment |
Countries
United States
Outcome results
None listed