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
|Condition or disease||Intervention/treatment||Phase|
|Pityriasis Rubra Pilaris||Drug: Ixekizumab||Phase 2|
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)|
|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|
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
Treatment at the FDA-approved psoriasis dosing
- 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.
- 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.
- 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).
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
|Contact: Teri M Greiling, MD, PhD||503-494-3376||PRPStudy@ohsu.edu|
|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|
|Principal Investigator:||Teri Greiling, MD, PhD||Oregon Health and Science University|