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Trial record 1 of 29 for:    Guselkumab
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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 : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Teri Greiling, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Pityriasis Rubra Pilaris Biological: guselkumab Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: guselkumab treatment
Treatment with guselkumab for 20 weeks
Biological: guselkumab
Treatment at the FDA-approved psoriasis dosing for 20 weeks
Other Name: Tremfya




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Teri Greiling, MD, PhD 503-494-3376 PRPstudy@ohsu.edu

Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Teri Greiling, MD, PhD Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Teri Greiling, Oregon Health and Science University:

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Responsible Party: Teri Greiling, Assistant Professor of Dermatology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03975153     History of Changes
Other Study ID Numbers: 00019343
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Teri Greiling, Oregon Health and Science University:
Interleukin-23, IL-23, guselkumab, Tremfya

Additional relevant MeSH terms:
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Pityriasis
Dermatitis, Exfoliative
Pityriasis Rubra Pilaris
Skin Diseases, Papulosquamous
Skin Diseases
Dermatitis
Skin Diseases, Eczematous