Efficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUS

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-003833-25-DE
• Date of registration: 16/10/2008
• Prospective Registration: Yes
• Primary sponsor: Universitätskrankenhaus Schleswig-Holstein
• Public title: Efficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUS
• Scientific title: Efficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUS
• Date of first enrolment: 05/02/2009
• Target sample size: 17
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003833-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
•Patients of any gender aged from 18 to 65 years;
•A clinical and histological diagnosis of CLE (DLE, SCLE or SLE with DLE or SCLE lesions) who failed to response to topical corticosteroids;
•One to 5 target lesions scoring at least “moderate disease” on the IGA scale;
•One to 5 target lesions with disease activity defined as having a local RCLASI sum scoring of at least 4 per lesion based on an assessment of erythema, scale/hyperkeratosis, edema/infiltration and subcutaneous nodule/plaque of the lesion;
•Willing and able to self-inject Efalizumab or has a carer (voluntary care giver) who is willing and able to perform the injections or willing and able to come weekly to the site to get the injection;
•Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and one month after the end of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Only scarring target lesions
•SLE with major organ involvement, requiring systemic medical treatment for the SLE;
•Active skin disease other than CLE or another progressive or serious disease that interferes with the study outcome
•Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study
•Active tuberculosis or other severe infection diseases, including chronic or localized
•Known malignancies other than effective treated non melanoma skin cancer
•Known thrombocytemia or anemia
•Concomitant, or within six weeks prior to dosing, systemic treatment with anti-malarials and/or concomitant or within four weeks prior to dosing, systemic treatment with corticosteroids, retinoids, thalidomide, immunosuppressive or other systemic drugs for CLE and SLE
•Treatment with immunosuppressive drugs for other reasons 4 weeks prior and within the study
•Topical corticosteroids within 14 days prior to dosing
•Concomitant treatment with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolebutamide;
•Known hypersensitivity to RAPTIVA® or any of its components
•Participation in another clinical trial including the four week period preceding the study or having received a non-licensed drug within the last 3 months prior to the study.
•Vaccination within 2 weeks prior dosing or planned vaccination during the study;




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cutaneous lupus erythematosus (discoid LE or subacute cutaneous LE) or systemic lupus erythematosus with cutaneous DLE or SCLE lesions without major organ involvment.
MedDRA version: 9.1 Level: LLT Classification code 10013071 Term: Discoid lupus erythematosis
MedDRA version: 9.1 Level: LLT Classification code 10057903 Term: Subacute cutaneous lupus erythematosus
MedDRA version: 9.1 Level: LLT Classification code 10056509 Term: Cutaneous lupus erythematosus

Intervention(s)

Trade Name: Raptiva
Pharmaceutical Form: Powder and solvent for solution for injection

Primary Outcome(s)

Secondary Objective: •the percentages of responders after 2, 4, 6, 8 and 10 weeks of treatment
•the treatment effect of Efalizumab with respect to change from baseline for the local RCLASI score after 2, 4, 6, 8, 10 and 12 weeks of treatment
•the treatment effect of Efalizumab with respect to changes from baseline in total RCLASI for the assessment of the overall disease activity and damage score in the patients after 12 weeks of treatment and at week 16 (Follow up Visit).
•the percentages of failures to treatment
•the Patient Assessment of Global Improvement (PAGI) and subject’s assessment of itching and pain assessed by a VAS after 2, 4, 6, 8, 10 and 12 weeks of treatment.
•the impact of the disease on QoL as determined by DLQI at Baseline and after 4, 8 and 12 weeks of treatment.
•the safety and tolerability aspects of Efalizumab in patients with CLE for the body as a whole.

Primary end point(s): The percentage of responders to treatment, based on the mean IGA at baseline and Visit 6. The IGA will be applied to the selected active lesions (target lesion) and each chosen target lesion will be assessed separately. The IGA will be scored at a 6-point scale where 0 is “Cleared of symptoms” and 5 “The worst state of disease symptoms” for each chosen target lesion. An improvement from baseline to Visit 6 by at least 1 point in the mean IGA score will be defined as response. No change or an increase will be defined as no response.

Main Objective: To evaluate the efficacy of Efalizumab 1 mg/kg in the treatment of CLE lesions with respect to the percentages of responders based on the investigators global assessment (IGA) score at baseline and after 12 weeks of treatment.

Secondary ID(s)

EFACLE2008