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Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

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ClinicalTrials.gov Identifier: NCT03975153
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Teri Greiling, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date August 7, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
Clinical improvement in PRP severity and body surface area [ Time Frame: 24 weeks ]
Clinical improvement will be measured by the Psoriasis Area and Severity Index (PASI) score. PASI is a scale that measures the severity (redness, scale, and elevation) of each body surface area of skin involved in psoriasis (a disease that has some similarities with PRP). Redness, scale, and elevation are each scored on a 0-4 point scale, added together, and multiplied by each body surface area involved (head and neck, trunk, upper limbs, lower limbs). The maximum score is 72 which would indicate the worst disease over every surface of someone's body. A scale of zero would indicate normal skin.
Change History Complete list of historical versions of study NCT03975153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Improvement in quality of life: Dermatology Life Quality Index (DLQI) [ 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.
  • Sustained remission [ 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
Official Title  ICMJE An Open Label Pilot Trial of Guselkumab in the Treatment of Adults With Pityriasis Rubra Pilaris (PRP)
Brief 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pityriasis Rubra Pilaris
Intervention  ICMJE Biological: guselkumab
Treatment at the FDA-approved psoriasis dosing for 20 weeks
Other Name: Tremfya
Study Arms  ICMJE Experimental: guselkumab treatment
Treatment with guselkumab for 20 weeks
Intervention: Biological: guselkumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of PRP by clinical assessment
  • Male age 18-99, willing to use a reliable form of birth control if sexually active with a woman who is able to become pregnant.
  • Female age 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks following the last dose of guselkumab.
  • Involved BSA ≥ 10% at baseline (moderate-to-severe disease).
  • Are a candidate for phototherapy and/or systemic therapy.

Exclusion Criteria:

  • Willingness to travel to OHSU for all study visits, or willing/able to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.
  • Known malignancy or lymphoproliferative disease (except treated basal cell skin cancer, treated squamous cell skin cancer, or treated cervical carcinoma in situ) for at least 5 years.
  • Active, untreated, acute or chronic infection, or immunocompromised to an extent that such that participation in the study would pose an unacceptable risk to the subject.
  • Positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
  • Have latent or active untreated tuberculosis (TB), a positive QuantiFERON-TB Gold test result, signs or symptoms of active TB on medical history or physical examination, or close contact with a person with active TB who have not undergone evaluation or treatment for TB. Those who are currently • Previous treatment with any agent that targets the interleukin 23 p19 subunit specifically.
  • Systemic treatment with prednisone in the last 2 weeks, or other systemic therapies or phototherapy for PRP within the past 4 weeks or 5 half-lives prior to baseline, whichever is longer. For biologic therapies, the specific washout periods used will be: etanercept <28 days; infliximab, adalimumab, i
  • Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the subject if participating in this study.
  • Have or intend to have a live vaccine within 3 months prior to baseline or 12 months prior to baseline in the case of the BCG vaccine, or any live vaccine during the course of study or within 3 months after the last administration of study drug.
  • Had any major surgery within 8 weeks prior to baseline or will require major surgery during the study, that in the opinion of the investigator would pose an unacceptable risk to the subject.
  • Presence of significant uncontrolled cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating • Have clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities: Neutrophil count <1500 cells/μL, white blood cell count <3500 cells/μL, platelet count <100,000
  • Women who are lactating or breastfeeding.
  • Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the investigator.
  • Are investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling).
  • Are currently enrolled in, or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Teri Greiling, MD, PhD 503-494-3376 PRPstudy@ohsu.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975153
Other Study ID Numbers  ICMJE 00019343
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Teri Greiling, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Teri Greiling, MD, PhD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP