IRB #

STUDY00019343

Title

An open label pilot trial of guselkumab in the treatment of adults with Pityriasis Rubra Pilaris (PRP)

Principal Investigator

Teri Greiling

Study Purpose

The purpose of this study is to determine whether guselkumab provides clinical improvement for subjects with pityriasis rubra pilaris (PRP).

Medical Condition(s)

pityriasis rubra pilaris, PRP

Eligibility Criteria

Subjects must be aged 18 - 99 years at time of screening visit. Subjects must have either an active diagnosis of moderate to severe PRP and are candidates for phototherapy and/or systemic therapy.

Subjects CANNOT have any of the following:
• Active, untreated, acute or chronic infection
• Previous treatment with any agent that targets IL-23p19 specifically
• History of cancer within the past 5 years

Healthy Volunteers Needed

No

Placebo Chance

N/A

Duration of Participation

Study duration is expected to last 36 weeks

Minors Included

No

Contact

Call 888-482-7546 or contact PRPStudy@ohsu.edu for more information

Sponsor

Janssen Scientific Affairs

Recruitment End

12/31/2021

Compensation Provided

Yes

Compensation

Participants will be paid $50 for all visits that do not involve skin biopsy (Screening and visits 3, 4, 5, and 7) and $150 for the three visits that involve skin biopsy (baseline, visit 2, and visit 6), for a total of $700. Other contacts are not reimbursed. For those subjects traveling >200 miles to OHSU, travel will be reimbursed at the federal Internal Revenue Service suggested rate of $0.545/mile up to 1000 miles (range $218 - $1090 for a round-trip visit to OHSU) for each of the three in-person visits (baseline, visit 2, and visit 6).


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