Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

NCT03485976 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00018031
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pityriasis Rubra Pilaris

Keywords

Ixekizumab; IL-17; Pityriasis Rubra Pilaris (PRP)

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement in PRP Severity and Body Surface Area

  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.

  24 weeks

Secondary Outcomes (2)

• Improvement in Quality of Life

  24 weeks

• Improvement in Itch

  24 weeks

Study Arms (1)

Ixekizumab treatment arm

EXPERIMENTAL

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

Interventions

Ixekizumab DRUG

Treatment at the FDA-approved psoriasis dosing

Also known as: Taltz, IL-17A inhibitor

Ixekizumab treatment arm

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Haynes D, Strunck JL, Topham CA, Ortega-Loayza AG, Kent G, Cassidy PB, Hu R, Choate K, Wang Z, Liu Y, Greiling TM. Evaluation of Ixekizumab Treatment for Patients With Pityriasis Rubra Pilaris: A Single-Arm Trial. JAMA Dermatol. 2020 Jun 1;156(6):668-675. doi: 10.1001/jamadermatol.2020.0932.

  PMID: 32293641 DERIVED

MeSH Terms

Conditions

Pityriasis Rubra Pilaris

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Teri Greiling, MD, PhD
• Organization: Oregon Health & Science University, Department of Dermatology

PRPStudy@ohsu.edu

503-494-8452

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: March 20, 2018
• First Posted: April 3, 2018
• Study Start: May 23, 2018
• Primary Completion: October 14, 2019
• Study Completion: January 13, 2020
• Last Updated: July 1, 2020
• Results First Posted: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)