Adult subjects of any ethnicity and either gender with Cutaneous Lupus Erythematosus lesions of Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of fumaric acid esters in the treatment of Cutaneous Lupus Erythematosus lesions. MedDRA version: 12.1 Level: LLT Classification code 10056509 Term: Cutaneous l
Conditions
Interventions
Trade Name: Fumaderm® initial
Product Name: -
Product Code: -
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Dimethylfumarat
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of any gender aged from 18 to 70 years; - A clinical and histological diagnosis of CLE (DLE, SCLE, LET, without major systemic involvement) who failed to response to topical corticosteroids; - Total RCLASI activity score of >6 (at least 3 points in at least 2 locations) on an assessment of erythema, scale/hyperkeratosis, edema/infiltration and subcutaneous nodule/plaque of the lesion (mucous membrane lesions/alopecia excluded); - Women of childbearing potential must agree to use at least one primary method of contraception and, at the same time, a secondary method of contraception from the time of screening, throughout trial treatment, and for at least one month after finishing treatment. - Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients unable to comply with the requirements of the study; - Only scarred cutaneous target lesions without activity; - Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease; - 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 severe infection diseases, including chronic or localized; - Known malignancies in the last 5 years, other than effective treated non melanoma skin cancer; - Severe liver- or kidney- disease; - Severe gastrointestinal disease, like gastric or duodenal ulcer; - Severe hematologic disorders; - Patients with leucopenia (<3.000/mm3); - Patients with lymphopenia (<500/mm3); - Patients with known hypersensitivity to fumaric acid esters or their derivatives, or to any study medication components; - Topical corticosteroids within 14 days prior to dosing; - Local treatment with fumaric acid derivates; - Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class); - Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study; - Concomitant treatment with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolebutamide; - Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine, nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole; - Drugs interfering/ interacting with fumaric acid esters; - Drugs with nephrotoxic potential, e.g. retinoids, psoralens, methotrexate, cyclosporine, immunosuppressants, cytostatics; - 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; - Pregnancy (according to pregnancy test) or nursing;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the therapeutic effect of fumaric acid esters (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).;Secondary Objective: -To evaluate the proportion of responders after 12 weeks of treatment. -To evaluate the treatment effect of fumaric acid esters (Fumaderm®) with respect to change from baseline in the total RCLASI activity score for skin lesions in comparison to week 12 and to the last day of treatment. -Time from start of treatment to first responce (time to response). -To evaluate the proportion of failures of therapy after 12 and 24 weeks of treatment. -To evaluate the Patient Assessment of Global Improvement (PAGI) score as well as subject’s assessment of itching and pain assessed by a Visual Analogue Scale (VAS) at baseline and after 12 and 24 weeks of treatment. -To evaluate the safety and tolerability aspects of fumaric acid esters (Fumaderm®) in patients with CLE for the body as a whole.;Primary end point(s): ?Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF). Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50"). | — |
Countries
Germany
Outcome results
None listed