A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pityriasis Rubra Pilaris
Intervention: Alefacept (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Icahn School of Medicine at Mount Sinai Official(s) and/or principal investigator(s): Joshua Zeichner, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
Summary
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.
Clinical Details
Official title: A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris.
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evidence of skin change - Physician's Global Assessment (PGA)Evidence of skin change - PRP Area and Severity Index (PASI)
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.
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subjects may be male or female, 30 years old or older at time of consent
2. Have a diagnosis of pityriasis rubra pilaris at least 6 months prior to
administration of the first dose of the study medication
3. Be a candidate for systemic therapy
4. 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.
5. Agree to adhere to the study visit schedule and protocol requirements, including
blood draws and clinical photographs.
6. Must be able to give informed consent, and this consent must be obtained prior to any
study related procedures being performed.
7. 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.
8. 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.
9. 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:
1. Subjects are pregnant or planning a pregnancy (both men and women) while enrolled in
the study.
2. Have used the medication alefacept in the past.
3. Have used another investigational medication within the past 4 weeks or within 5
times the half-life of that investigational medicine.
4. Have received systemic medications that could affect pityriasis rubra pilaris within
4 weeks of administration of the first dose of the study medicine.
5. Have used topical medications that could affect pityriasis rubra pilaris within 2
weeks of administration of the first dose of the study medicine.
6. Have received a live viral or bacterial vaccine within 3 months of administration of
the first dose of the study medicine.
7. Have a history of chronic or recurrent infections of the skin or internal organs.
8. Have had a serious infection requiring hospitalization or intravenous antibiotics
within 2 weeks of administration of the first dose of the study medicine.
9. Have a history of latent untreated tuberculosis.
10. Have a known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis
C virus.
11. 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.
12. Have a known hypersensitivity to any component of alefacept.
13. Have a known substance abuse problem or is deemed by the investigator as unable to
follow the study protocol.
14. Is participating in another study for an investigational agent or procedure during
the course of this study.
Locations and Contacts
Mount Sinai School of Medicine, New York, New York 10029, United States
Additional Information
Starting date: December 2008
Last updated: November 9, 2009
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