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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pityriasis Rubra Pilaris	Drug: Alefacept	Phase 4

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	10 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris.
Study Start Date :	December 2008
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	December 2009

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Evidence of skin change - Physician's Global Assessment (PGA) [ Time Frame: wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24 ]
2. Evidence of skin change - PRP Area and Severity Index (PASI) [ Time Frame: wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24 ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Astellas Pharma Inc

Investigators

Principal Investigator:	Joshua Zeichner, MD	Icahn School of Medicine at Mount Sinai

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Joshua Zeichner, MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00815633 History of Changes
Other Study ID Numbers:	08-0514; JM-08-001
First Posted:	December 30, 2008
Last Update Posted:	November 10, 2009
Last Verified:	November 2009

Keywords provided by Icahn School of Medicine at Mount Sinai:

PRP; Pityriasis Rubra Pilaris; Amevive; Alefacept	Biologic; Immunosuppressant; Severe skin disease

Additional relevant MeSH terms:

Pityriasis; Dermatitis, Exfoliative; Pityriasis Rubra Pilaris; Skin Diseases, Papulosquamous; Skin Diseases	Dermatitis; Skin Diseases, Eczematous; Alefacept; Dermatologic Agents