Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

NCT03975153 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 00019343
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pityriasis Rubra Pilaris

Keywords

Interleukin-23, IL-23, guselkumab, Tremfya

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline Psoriasis Area and Severity Index (PASI) at Week-24 After Treatment With Guselkumab.

  PASI measures the appearance of the skin based on erythema, scale, and elevation, multiplied by body surface area. 0 indicates completely clear skin. 72 is the maximum value, indicating the worst severity. A score of 11 or higher is considered severe disease.

  24 weeks

Secondary Outcomes (2)

• Proportion of Subjects Achieving a 4-point Improvement in Quality of Life Measured by the Dermatology Life Quality Index (DLQI) at Week-24.

  24 weeks

• Proportion of Subjects With >50% Improvement With Psoriasis Area and Severity Index (PASI) at Week-24 Who Did Not Worsen at Week-36

  36 weeks

Study Arms (1)

guselkumab treatment

EXPERIMENTAL

Treatment with guselkumab for 20 weeks

Biological: guselkumab

Interventions

guselkumab BIOLOGICAL

Treatment at the FDA-approved psoriasis dosing for 20 weeks

Also known as: Tremfya

guselkumab treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 body surface area (BSA) ≥ 10% at baseline (moderate-to-severe disease).
• Are a candidate for phototherapy and/or systemic therapy.

You may not qualify if:

• Willingness to travel to Oregon Health and Science University (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 Bacillus Calmette-Guerin (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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Velasco RC, Shao C, Cutler B, Strunck J, Kent G, Cassidy PB, Choate K, Greiling TM. Guselkumab for Pityriasis Rubra Pilaris and Dysregulation of IL-23/IL-17 and NFkB Signaling: A Nonrandomized Trial. JAMA Dermatol. 2024 Jun 1;160(6):641-645. doi: 10.1001/jamadermatol.2024.0257.

  PMID: 38598229 DERIVED

MeSH Terms

Conditions

Pityriasis Rubra Pilaris

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Pityriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Limitations of the study: open label design, small sample size, lack of validated outcomes measures for PRP, racial and ethnic homogeneity of the participants

Results Point of Contact

• Title: Teri Greiling, MD, PhD, FAAD
• Organization: Oregon Health & Science University

PRPStudy@ohsu.edu

503-494-3376

Study Officials

• Teri Greiling, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: October 3, 2019
• Primary Completion: August 11, 2022
• Study Completion: March 22, 2024
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)