OSHU Studies PRP and Taltz (ixekizumab)

From the Editor…

Nearly one year ago (May 17, 2017) I received an email from Dr. Teri Greiling,  Assistant Professor of Dermatology at Oregon Health and Science University in Portland, Oregon.

Like every PRP patient and caregiver, Dr. Greiling lamented the fact that not a single therapeutic trial had ever been conducted for patients with PRP. She also recognized that PRP was also lacking validated measurement tools to properly gauge the severity of our disease. Inspired by one of her PRP patients, she decided to do something. She pondered the question we want PRP researchers to ponder: What if…?

She wanted to go beyond clinical trials and re-invigorate a PRP Registry with questionnaires to “active” PRP patients every six months updating their disease activity, symptoms, and medications used. She wrote: “The more information we have about how severely PRP affects quality of life and which medications are useful or not, the better equipped we are for future therapeutic trials.”

We started talking. She kept thinking. She wrote a proposal. On May 8, 2018. I received the long-awaited call. All the approvals had been made by OHSU and Lilly (manufacturer of Taltz®) and Dr. Greiling’s PRP research project had been given the green light to treat patients with PRP.


Editors Note: The following information comes directly from ClinicalTrials.gov.
Official Title: Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP) and reflects a minimal amount of copyediting and re-formatting to increase readability. We recommend that you review the OHSU posting at ClinicalTrials.gov.
Sponsors & Collaborators
✽  Eli Lilly and Company
Principle Investigator, Responsible Party and Contact
✽  Teri M. Greiling, MD, PHD, Oregon Health and Science University
Phone: 503-494-3376
Brief Summary:
✽  Fifteen patients with PRP will be treated with ixekizumab (Taltz® for 24 weeks to determine safety and efficacy.
✽  Participants are required to travel to Portland, OR only for the first visit and a visit in Week #24.
✽  Five visits in between these times and one follow up visit may be performed by secure videoconferencing.
Study Type:
✽  Interventional (Clinical Trial)
Editor’s Note: Interventional study (clinical trial) A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. Source: ClinicalTrials.gov (Glossary)
 
Estimated Enrollment:
✽  15 participants
Timeline:
✽  Estimated Study Start Date: May 1, 2018
✽  Estimated Study Completion Date: November 30, 2019
Protocol:
✽ Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20
Primary Outcome Measures:
✽  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.
Secondary Outcome Measures:
✽  Clinical improvement in PRP severity and body surface area [ 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.

Improvement in itch [ Time Frame: 24 weeks ]
✽  Itch will be measured using a numeric rating scale from 0 (no itch) to 10 (worst itch imaginable)

Inclusion Criteria
✽  Gender: All sexes eligible
✽  Diagnosis of PRP by clinical assessment and biopsy.
✽  Male subject age: 18-99
✽  Female subject 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 ixekizumab.
✽  PASI score of 10 or greater at baseline.
✽  Are a candidate for phototherapy and/or systemic therapy.
✽  Willingness to travel to OHSU for TWO study visits, OR living less than 30 miles from OHSU and willing/able to participate in remote videoconferencing visits with access to a computer with internet capabilities and webcam.
✽  Have given written informed consent approved by the OHSU Investigational Review Board
Exclusion Criteria
✽  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 (such as untreated tuberculosis), or immunocompromised to an extent that such that participation in the study would pose an unacceptable risk to the subject. (Treated infections such as latent tuberculosis after completion of the appropriate therapy are not excluded.)
✽  Positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.

✽  Previous treatment with any agent that targets interleukins 17 specifically.
✽  Systemic treatment 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, or alefacept <60 days; golimumab <90 days; ustekinumab <8 months; rituximab or efalizumab <12 months.
✽  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 a live vaccine within 12 weeks prior to baseline or intend to have a live vaccine during the course of study.
✽  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 in the study or of interfering with the interpretation of the data.
✽  Presence of inflammatory bowel disease
✽  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, lymphocyte count <500 cells/µL, platelet count <100,000 cells/µL, AST or ALT > 2.5 times the upper limit of normal, hemoglobin <8.5 g/dL for male subjects and <8.0 g/dL for female subjects, serum creatinine >2.0 mg/dL.
✽  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.