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

PITYRIASIS RUBRA PILARIS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342573
• Other study ID #: 16-006987
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2018
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis, Exfoliative
• Pityriasis Rubra Pilaris

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI-75	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	28 weeks
Secondary	PASI-90	PASI-90 response rate: the number of study participants with a PASI percent improvement from baseline of = 90%	28 weeks
Secondary	DLQI	Dermatology Quality of Life Index - mean change before and after treatment	28 weeks
Secondary	PGA	Physician Global assessment - mean change before and after treatment	28 weeks

External Links

•   Mayo Clinic Clinical Trials