Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2018
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedFebruary 24, 2022
February 1, 2022
3.8 years
October 18, 2017
February 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
PASI-90
28 weeks
DLQI
28 weeks
PGA
28 weeks
Study Arms (1)
Single Arm
EXPERIMENTALPatients with a biopsy proven diagnosis of PRP
Interventions
Cosentyx 300 mg SQ week 0-4, then every q4 weeks for a total of 28 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Related Publications (1)
Boudreaux BW, Pincelli TP, Bhullar PK, Patel MH, Brumfiel CM, Li X, Heckman MG, Pittelkow MR, Mangold AR, Sluzevich JC. Secukinumab for the treatment of adult-onset pityriasis rubra pilaris: a single-arm clinical trial with transcriptomic analysis. Br J Dermatol. 2022 Nov;187(5):650-658. doi: 10.1111/bjd.21708. Epub 2022 Jul 15.
PMID: 35701384DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason C Sluzevich
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 18, 2017
First Posted
November 17, 2017
Study Start
April 1, 2018
Primary Completion
January 1, 2022
Study Completion
February 1, 2022
Last Updated
February 24, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share