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

NCT ID: NCT03342573

Last Updated: 2022-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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PITYRIASIS RUBRA PILARIS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cosentyx (Secukinumab) for the treatment of adult onset pityriasis rubra pilaris
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Patients with a biopsy proven diagnosis of PRP

Group Type EXPERIMENTAL

Cosentyx

Intervention Type DRUG

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

Interventions

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Cosentyx

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

Intervention Type DRUG

Other Intervention Names

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Secukinumab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jason Sluzevich MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason C Sluzevich

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35701384 (View on PubMed)

Related Links

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Other Identifiers

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16-006987

Identifier Type: -

Identifier Source: org_study_id

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