Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva

The purpose of this study is to investigate the efficacy of Raptiva (efalizumab) in the treatment of discoid lupus erythematosus (DLE). Discoid lupus erythematosus is a chronic disorder, which may lead to permanent and progressive loss of hair. Lupus is a condition of chronic inflammation cause by an autoimmune disease. Autoimmune diseases are illnesses which occur when the body's tissues are attacked by its own immune system. The immune system is a complex system within the body that is designed to fight infectious agents, for example, bacteria, and other foreign invaders.

One of the mechanisms that the immune system uses to fight infections is the production of antibodies. Patients with lupus produce abnormal antibodies in their blood that target tissues within their own body rather than foreign infectious agents. Lupus can cause disease of the skin, heart, lungs, kidneys, joints, and nervous system. When only the skin is involved, the condition is called discoid lupus erythematosus (DLE).

Raptiva (efalizumab) is a humanized immunoglobulin(a protein extract from blood which fights off infection-sometimes called "antibody"), which targets the immune cells that are activated in inflammation. Raptiva has been approved for use in the management of psoriasis at doses of 1mg/kg, but is not approved for the treatment of DLE.

Study Overview

• Status: Withdrawn
• Conditions: Discoid Lupus Erthematosus of the Scalp
• Intervention / Treatment: Drug: Raptiva

Detailed Description

This is an open label study in which the subject will be given the medication Raptiva (efalizumab) and they will be taught to self-inject by the dermatology nurse or research doctor. The subject will be administering 0.7mg/kg at week one and 1mg/kg once a week thereafter until week 24. If the subject feels uncomfortable self-administering these injections, the subject may identify a caregiver to administer these injections for them. He or she will be taught to administer these injections by the dermatology nurse or research doctor.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adults with discoid lupus erythematosus with active area of disease involving at least 10% of scalp, confirmed by biopsy, bacterial and fungal culture negative.
• ability to provide written informed consent and comply with study assessments for the full duration of the study.
• adults 18 to 70 years of age.
• if a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.
• if a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.
• Platelets >100,000

Exclusion Criteria:

• subjects with known hypersensitivity to Raptiva (efalizumab) or any of its components
• pregnant or lactating women
• patients receiving immunosuppressive agents (not allowed 30 days or 5 half-live periods before Day 0, whichever is longer).
• prior enrollment in the study
• any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
• participation in another simultaneous medical investigation or trial
• history of malignancy in the last 10 years.
• signs or symptoms of systemic lupus erythematosus.
• have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test or chest x-ray will be performed at the screening visit. Patients with a positive PPD test or chest x-ray will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Raptiva; raptiva injection	Drug: Raptiva; injection; Other Names: efalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy in growing scalp hair	A 10% increase in visualized hair count in the target region between baseline and week 24 as determined by macrophotography and validated computer assisted dot mapping technique.	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical improvement of disease	Physician's global assessment (PGA) will be used to assess improvement of disease.	36 weeks

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Wilma F Bergfeld, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2006
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: March 28, 2006
• First Submitted That Met QC Criteria: March 28, 2006
• First Posted (Estimate): March 29, 2006

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: lupus; discoid lupus erythematosus; discoid lupus; lupus of the scalp
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid
• Other Study ID Numbers: ACD3433s

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No