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Trial record 2 of 3 for:    pityriasis rubra pilaris

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

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ClinicalTrials.gov Identifier: NCT03342573
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Jason Sluzevich MD, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
PITYRIASIS RUBRA PILARIS Drug: Cosentyx Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Cosentyx (Secukinumab) for the treatment of adult onset pityriasis rubra pilaris
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open-label Exploratory Trial
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : April 15, 2020


Arm Intervention/treatment
Experimental: Single Arm
Patients with a biopsy proven diagnosis of PRP
Drug: Cosentyx
Cosentyx 300 mg SQ week 0-4, then every q4 weeks for a total of 28 weeks.
Other Name: Secukinumab




Primary Outcome Measures :
  1. PASI-75 [ Time Frame: 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 Outcome Measures :
  1. PASI-90 [ Time Frame: 28 weeks ]
    PASI‐90 response rate: the number of study participants with a PASI percent improvement from baseline of ≥ 90%

  2. DLQI [ Time Frame: 28 weeks ]
    Dermatology Quality of Life Index - mean change before and after treatment

  3. PGA [ Time Frame: 28 weeks ]
    Physician Global assessment - mean change before and after treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342573


Locations
United States, Arizona
Mayo Clinic in Arizona Not yet recruiting
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Jason Sluzevich, MD    904-953-7214    sluzevich.jason@mayo.edu   
Principal Investigator: Jason C Sluzevich         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jason C Sluzevich Mayo Clinic

Responsible Party: Jason Sluzevich MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03342573     History of Changes
Other Study ID Numbers: 16-006987
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
Pityriasis
Dermatitis, Exfoliative
Pityriasis Rubra Pilaris
Skin Diseases, Papulosquamous
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs