NCT03975153

Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

An Open Label Pilot Trial of Guselkumab in the Treatment of Adults With Pityriasis Rubra Pilaris (PRP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

15 patients with PRP will be treated with guselkumab for 20 weeks to determine safety and efficacy. Participants are required to travel to Portland, OR only for the first visit, week-4 visit, and week-24 visit. 3 visits in between these times and one follow up visit may be performed by secure videoconferencing.

Detailed description

Pityriasis rubra pilaris (PRP) is a rare and poorly understood severe inflammatory skin disease characterized by widespread (often full-body) redness and flaking of the skin, painful thickening and cracking of the palms and soles, hair loss, crumbling nails, and severe skin itching and burning. There is no FDA-approved therapy for this rare disease and the commonly used medications do not work for many patients. There is some evidence that interleukin (IL)-23 may be too high in the skin of PRP patients. Ixekizumab is an injectable medication that blocks IL-23 by binding the p19 subunit and is FDA-approved for psoriasis.

Conditions

• Pityriasis Rubra Pilaris

Interventions

Type	Name	Description
BIOLOGICAL	guselkumab	Treatment at the FDA-approved psoriasis dosing for 20 weeks

Timeline

• Start date: 2019-10-03
• Primary completion: 2022-08-11
• Completion: 2024-03-22
• First posted: 2019-06-05
• Last updated: 2024-05-24
• Results posted: 2024-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study