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Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

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ClinicalTrials.gov Identifier: NCT03485976
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Teri Greiling, Oregon Health and Science University

Brief Summary:
15 patients with PRP will be treated with ixekizumab for 24 weeks to determine safety and efficacy. Participants are required to travel to Portland, OR only for the first visit and week-24 visit. 5 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 Drug: Ixekizumab 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-17 may be too high in the skin of PRP patients. Ixekizumab is an injectable medication that blocks IL-17 and is FDA-approved for psoriasis.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : November 30, 2019


Arm Intervention/treatment
Experimental: Ixekizumab treatment arm
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
Drug: Ixekizumab
Treatment at the FDA-approved psoriasis dosing
Other Names:
  • Taltz
  • IL-17A inhibitor




Primary Outcome Measures :
  1. 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 :
  1. Improvement in quality of life [ 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.

  2. 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).



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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 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 all study visits, OR living >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.


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): NCT03485976


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

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Teri M Greiling, MD, PhD    888-482-7546    PRPstudy@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Eli Lilly and Company
Investigators
Principal Investigator: Teri Greiling, MD, PhD Oregon Health and Science University

Responsible Party: Teri Greiling, Assistant Professor of Dermatology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03485976     History of Changes
Other Study ID Numbers: STUDY00018031
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Ixekizumab
IL-17
Pityriasis Rubra Pilaris (PRP)

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