A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris

A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris.

The purpose of this study is to determine whether the biologic medication alefacept (Amevive) is effective and safe in the treatment of Pityriasis Rubra Pilaris.

Study Overview

• Status: Terminated
• Conditions: Pityriasis Rubra Pilaris
• Intervention / Treatment: Drug: Alefacept

Detailed Description

Pityriasis Rubra Pilaris (PRP) is a therapeutic challenge, and many different medication regimens exist to treat the condition. Clinical response is variable, and no single treatment has emerged as a leading therapy. Biologic agents have emerged as effective treatments for many skin diseases, including psoriasis. Given the clinical overlap between PRP and psoriasis, it is logical to attempt to use these agents for PRP. Since the majority of patients with PRP are unresponsive to current therapies, new treatment modalities must be evaluated. This study will evaluate the treatment of adult 30 years or older with a diagnosis of PRP, either subtypes 1 or 2. In this study, the safety and efficacy of alefacept will be evaluated in adult patients with PRP refractory to current treatments. Alefacept is a dimeric fusion protein containing the CD2 extracellular binding region of human leukocyte function antigen-3 (LFA-3) linked to the Fc portion of human IgG1. The drug binds to the T-lymphocyte antigen CD2 and blocks its interaction with LFA-3 on antigen presenting cells in the body. The CD2/LFA-3 interaction is a key co-stimulatory signal in the activation of T-lymphocytes central to the pathophysiology of psoriasis. It is theorized this interaction plays a role in the pathophysiology of PRP. Alefacept is currently approved for the treatment of adults with moderate to severe, chronic, plaque-type psoriasis. The medication is administered as weekly intramuscular injections for 12 week courses. In this study, a dose of 15mg alefacept will be administered intramuscularly at weekly intervals for 12 weeks. This is the dosing regimen currently approved for the treatment of psoriasis. Patients will be followed for a total of 24 weeks.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects may be male or female, 30 years old or older at time of consent
• Have a diagnosis of pityriasis rubra pilaris at least 6 months prior to administration of the first dose of the study medication
• Be a candidate for systemic therapy
• Women of childbearing potential and all men must use adequate contraceptive measures if sexually active. Examples include abstinence, oral contraceptives or other form of hormonal contraception, intrauterine devices, surgical sterilization, or barrier forms of contraception with spermicidal jelly. Subjects must agree to continue to use these contraceptive measures and agree not to become or plan a pregnancy within 12 months of the date of the last study drug administration.
• Agree to adhere to the study visit schedule and protocol requirements, including blood draws and clinical photographs.
• Must be able to give informed consent, and this consent must be obtained prior to any study related procedures being performed.
• Must avoid other treatment modalities during the course of the study and adhere to standard washout periods for any medications used to treat their skin prior to receiving the first dose of study medication.
• Must agree not to receive a live viral or bacterial vaccine during the course of the study or for 12 months after the date of the last study drug administration.
• Have screening blood tests that are stable as deemed by the physician investigator. AST, ALT and alkaline phosphatase levels must be within 2.0 times the upper limit of normal to participate.

Exclusion Criteria:

• Subjects are pregnant or planning a pregnancy (both men and women) while enrolled in the study.
• Have used the medication alefacept in the past.
• Have used another investigational medication within the past 4 weeks or within 5 times the half-life of that investigational medicine.
• Have received systemic medications that could affect pityriasis rubra pilaris within 4 weeks of administration of the first dose of the study medicine.
• Have used topical medications that could affect pityriasis rubra pilaris within 2 weeks of administration of the first dose of the study medicine.
• Have received a live viral or bacterial vaccine within 3 months of administration of the first dose of the study medicine.
• Have a history of chronic or recurrent infections of the skin or internal organs.
• Have had a serious infection requiring hospitalization or intravenous antibiotics within 2 weeks of administration of the first dose of the study medicine.
• Have a history of latent untreated tuberculosis.
• Have a known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
• Have a history of a malignancy except for squamous cell or basal cell carcinoma of the skin or cervical carcinoma in situ that has been treated with no evidence of recurrence.
• Have a known hypersensitivity to any component of alefacept.
• Have a known substance abuse problem or is deemed by the investigator as unable to follow the study protocol.
• Is participating in another study for an investigational agent or procedure during the course of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alefacept; Treatment Group (only one group)	Drug: Alefacept; 15mg intramuscular injection weekly for 12 weeks; Other Names: Amevive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evidence of Skin Change - Physician's Global Assessment (PGA)	wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24
Evidence of Skin Change - PRP Area and Severity Index (PASI)	wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24

Collaborators and Investigators

• Sponsor: Joshua Zeichner
• Collaborators: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: December 29, 2008
• First Submitted That Met QC Criteria: December 29, 2008
• First Posted (Estimate): December 30, 2008

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Biologic; PRP; Immunosuppressant; Amevive; Alefacept; Pityriasis Rubra Pilaris; Severe skin disease
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Exfoliative; Pityriasis; Pityriasis Rubra Pilaris; Physiological Effects of Drugs; Immunologic Factors; Dermatologic Agents; Alefacept
• Other Study ID Numbers: GCO 08-0514; JM-08-001