Pityriasis Rubra PilarisPhase 2NCT03975153
Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
A Phase 2 study testing guselkumab in people with Pityriasis Rubra Pilaris, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pityriasis Rubra Pilaris
- What is being tested?
- guselkumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2019to 22 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: An Open Label Pilot Trial of Guselkumab in the Treatment of Adults With Pityriasis Rubra Pilaris (PRP)
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.
Read the 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
- Being tested
- guselkumab
- Keywords
- Interleukin-23, IL-23, guselkumab, Tremfya
- Medical subject headings
- Pityriasis Rubra Pilaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guselkumabBiological
Also called Tremfya
Treatment at the FDA-approved psoriasis dosing for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| guselkumab treatment | Experimental | Treatment with guselkumab for 20 weeks Receives: Biological: guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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 improvement in DLQI score is considered clinically important.
Measured: 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
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. Trial participants who had a decrease in PASI by >50% from week-0 to week-24 were included in this analysis. Participants did not receive any additional doses of guselkumab after week-20, and PASI score at week-36 was calculated to assess for sustained remission.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start3 Oct 2019
- Primary completion11 Aug 2022
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pityriasis Rubra PilarisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teri Greiling, Oregon Health and Science University
- Investigators
- Teri Greiling, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975153
- Sponsor's protocol ID
- 00019343
- Status last verified
- May 2024
- First submitted
- 3 Jun 2019
- Last updated
- 24 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38598229
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Trial of Guselkumab in the Treatment of Adults With Pityriasis Rubra Pilaris (PRP)
- ClinicalTrials.gov ID
- NCT03975153
- Acronym / sponsor ID
- 00019343
- Conditions
- Pityriasis Rubra Pilaris
- Keywords
- Interleukin-23, IL-23, guselkumab, Tremfya
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Posted 24 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| guselkumab treatment | Experimental | Biological: guselkumabTreatment with guselkumab for 20 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guselkumabAlso: TremfyaTreatment at the FDA-approved psoriasis dosing for 20 weeks | Biological | guselkumab treatment |
Primary outcome
Mean Change From Baseline Psoriasis Area and Severity Index (PASI) at Week-24 After Treatment With Guselkumab.
Time frame: 24 weeks
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.
2 secondary outcomes
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
Proportion of Subjects With >50% Improvement With Psoriasis Area and Severity Index (PASI) at Week-24 Who Did Not Worsen at Week-36
Time frame: 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38598229Velasco 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.
- Individual participant dataSharing planned: No
Related trials for Pityriasis Rubra Pilaris
Not yet recruitingPhase 4
Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris (PRP)
Pityriasis Rubra Pilaris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teri Greiling, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing guselkumab in people with Pityriasis Rubra Pilaris, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline Psoriasis Area and Severity Index (PASI) at Week-24 After Treatment With Guselkumab. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.