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OpenTrials
Completed

NCT Number: NCT03342573

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

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.

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Key information

Conditions

Pityriasis Rubra Pilaris Pityriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cosentyx

Drug

Cosentyx 300 mg SQ week 0-4, then every q4 weeks for a total of 28 weeks.

Other names: Secukinumab

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2017
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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