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

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-006987
    • Jacksonville, Florida: 16-006987
    • Rochester, Minnesota: 16-006987
    NCT ID: NCT03342573
    Sponsor Protocol Number: 16-006987

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jason Sluzevich, M.D.

Open for enrollment

Contact information:

Aaron Mangold M.D.

(480)301-5686

Mangold.Aaron@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Sluzevich, M.D.

Open for enrollment

Contact information:

Jason Sluzevich M.D.

(904)953-7214

Sluzevich.Jason@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Jason Sluzevich, M.D.

Contact us for the latest status

Contact information:

Katrina Pierce

(507)266-1078

Pierce.Katrina@mayo.edu

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CLS-20385434

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