Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03975153|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pityriasis Rubra Pilaris||Biological: guselkumab||Phase 2|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Pilot Trial of Guselkumab in the Treatment of Adults With Pityriasis Rubra Pilaris (PRP)|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: guselkumab treatment
Treatment with guselkumab for 20 weeks
Treatment at the FDA-approved psoriasis dosing for 20 weeks
Other Name: Tremfya
- Mean change from baseline PASI at week-24 after treatment with guselkumab. [ Time Frame: 24 weeks ]The Psoriasis Severity Index (PASI) is a well-validated tool for measuring psoriasis, based on redness, thickness, scale, and body surface area assessed by the investigator, with a maximum score of 72 points for the worst disease, and a score of 0 for clear skin. This is expected to be a useful tool for PRP, since PRP is characterized by widespread bright red erythema and scale, and is often initially misdiagnosed as severe psoriasis. The mean thickness score is expected to be lower in PRP than psoriasis but the mean body surface area (BSA) is expected to be higher than psoriasis.
- Proportion of subjects achieving a 4-point improvement in quality of life measured by the Dermatology Life Quality Index (DLQI) at week-24. [ Time Frame: 24 weeks ]Quality of life will be measured by the Dermatology Life Quality Index (DLQI). There are 10 questions covering symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question refers to the impact of PRP on the patient's life over the previous week. The highest score is 30 and would indicate a maximum (negative) impact on quality of life. A score of zero would indicate no impact on quality of life. For inflammatory skin conditions, a 4-point change in DLQI score is considered clinically important.
- Proportion of subjects with sustained remission at week-36, 16 weeks after the last guselkumab dose, as measured by the mean change in PASI from week-24 to week-36. [ Time Frame: 36 weeks ]Subjects will be treated with guselkumab as per the FDA-approved psoriasis treatment guidelines, and therapy will be stopped after the 20-week dose. Subjects will be monitored at 24 weeks (primary study endpoint) and then at 36 weeks to assess for sustained remission versus relapse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975153
|Contact: Teri Greiling, MD, PhD||503-494-3376||PRPstudy@ohsu.edu|
|Principal Investigator:||Teri Greiling, MD, PhD||Oregon Health and Science University|