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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: PITYRIASIS RUBRA PILARIS

Treatments: Drug: Cosentyx

Study type: Interventional

Funder types: Other

Identifiers

NCT03342573

16-006987

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Single Arm

Experimental group

Description:

Patients with a biopsy proven diagnosis of PRP

Treatment:

Drug: Cosentyx