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

Phase 1

Completed

• Conditions: PITYRIASIS RUBRA PILARIS
• Interventions: Drug: Cosentyx

• Registration Number: NCT03342573
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Study Start: 2018-04-01
• Primary Completion: 2022-01-01
• Status Verified: 2022-02
• Study Completion: 2022-02-01
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Cosentyx	Patients with a biopsy proven diagnosis of PRP

Primary Outcome Measures

Name	Time	Method
PASI-75	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

Name	Time	Method
PASI-90	28 weeks	PASI-90 response rate: the number of study participants with a PASI percent improvement from baseline of ≥ 90%
DLQI	28 weeks	Dermatology Quality of Life Index - mean change before and after treatment
PGA	28 weeks	Physician Global assessment - mean change before and after treatment

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States