- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342573
Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris
February 23, 2022 updated by: Jason Sluzevich MD, Mayo Clinic
Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open-label Exploratory Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic in Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
Patients with a biopsy proven diagnosis of PRP
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Cosentyx 300 mg SQ week 0-4, then every q4 weeks for a total of 28 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PASI-75
Time Frame: 28 weeks
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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
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28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PASI-90
Time Frame: 28 weeks
|
PASI-90 response rate: the number of study participants with a PASI percent improvement from baseline of ≥ 90%
|
28 weeks
|
DLQI
Time Frame: 28 weeks
|
Dermatology Quality of Life Index - mean change before and after treatment
|
28 weeks
|
PGA
Time Frame: 28 weeks
|
Physician Global assessment - mean change before and after treatment
|
28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason C Sluzevich, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
February 1, 2022
Study Registration Dates
First Submitted
October 18, 2017
First Submitted That Met QC Criteria
November 13, 2017
First Posted (Actual)
November 17, 2017
Study Record Updates
Last Update Posted (Actual)
February 24, 2022
Last Update Submitted That Met QC Criteria
February 23, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-006987
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PITYRIASIS RUBRA PILARIS
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Joshua ZeichnerAstellas Pharma IncTerminatedPityriasis Rubra PilarisUnited States
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Oregon Health and Science UniversityActive, not recruitingPityriasis Rubra PilarisUnited States
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Oregon Health and Science UniversityEli Lilly and CompanyCompletedPityriasis Rubra PilarisUnited States
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Universidad Autonoma de San Luis PotosíHospital Central "Dr. Ignacio Morones Prieto"Completed
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Research Institute of Epidemiology, Microbiology...Active, not recruitingPityriasis AlbaUzbekistan
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St Joseph University, Beirut, LebanonUnknown
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Kasr El Aini HospitalRecruiting
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Kasr El Aini HospitalRecruiting
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National Taiwan University HospitalUnknownRosacea | Meibomian Gland Dysfunction | Blepharitis | Demodex Infestation | Pityriasis FolliculorumTaiwan
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Cairo UniversityUnknownPityriasis LichenoidesEgypt
Clinical Trials on Cosentyx
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Novartis PharmaceuticalsRecruitingModerate-to-severe Plaque PsoriasisRussian Federation
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Novartis PharmaceuticalsAvailableHidradenitis Suppurativa (HS)
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University of California, San FranciscoNovartis PharmaceuticalsCompleted
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Novartis PharmaceuticalsActive, not recruitingModerate to Severe Chronic Plaque PsoriasisChina
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Novartis PharmaceuticalsActive, not recruitingPsoriasis Vulgaris | Pustular Psoriasis | Psoriatic ArthritisJapan
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Beth Israel Deaconess Medical CenterNovartis PharmaceuticalsTerminatedNecrobiosis Lipoidica DiabeticorumUnited States
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Massachusetts General HospitalNovartisWithdrawnDiscoid Lupus ErythematosusUnited States
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Diamant ThaciNovartisCompleted
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Tanja Todberg, MDUnknown