Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE

• Register: EUCTR
• Last refreshed on: 28 August 2014
• Main ID: EUCTR2010-023645-29-DE
• Date of registration: 11/01/2011
• Prospective Registration: Yes
• Primary sponsor: Universitätsklinikum Münster
• Public title: Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE
• Scientific title: Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE
• Date of first enrolment: 15/03/2011
• Target sample size: 11
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023645-29
• 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 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:
- 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;


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

Health Condition(s) or Problem(s) studied

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 lupus erythematosus
MedDRA version: 12.1 Level: PT Classification code 10056509 Term: Cutaneous lupus erythematosus

Intervention(s)

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: equal
Concentration number: 30-
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 67-
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Trade Name: Fumaderm®
Product Name: -
Product Code: -
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Dimethylfumarat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 87-
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Primary Outcome(s)

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).

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").

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.

Secondary ID(s)

UKM 10_0020