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Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus (FumaCLE)

Primary Purpose

Lupus Erythematosus, Cutaneous

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Fumaric acid esters
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Cutaneous focused on measuring C17.300.475, C17.800.480

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 preferably, 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.

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 tolbutamide;
  • 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.

Sites / Locations

  • Department of Dermatology, University Hospital Muenster

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fumaric acid esters

Arm Description

Outcomes

Primary Outcome Measures

Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely.
Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50").

Secondary Outcome Measures

Proportion of patients with RCLASI 50 at week 12 of treatment
Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions)
Time from start of treatment to first RCLASI 50 assessment (time to response).
Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment and at the end of therapy.
Number of Participants with Adverse Events (AEs) and their severity.

Full Information

First Posted
April 29, 2011
Last Updated
February 27, 2014
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT01352988
Brief Title
Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus
Acronym
FumaCLE
Official Title
Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Mono-Centre, Open-Label, Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is 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).
Detailed Description
At screening, patients meeting the inclusion and exclusion criteria will be asked to provide written informed consent. Male patients and female patients without childbearing potential will also complete other screening procedures including vital signs, physical examination, and patients and physicians efficacy assessments. Treatment will be started as soon as possible after screening and not later than 1 month after screening. The patients will receive a treatment either with Fumaderm® initial and/or Fumaderm® enteric-coated tablets. Fumaderm® initial will be usually administered during the first three weeks of treatment and / or during the trial when adaptation of the daily dosage will be required due to the occurrence of adverse reactions, e.g gastrointestinal. Throughout the trial, daily use of sunscreens (sun protection factor, SPF≥50) will be recommended to all patients. The management of CLE may also involve the use of topical medications, such as topical steroids, or systemic rescue medications, such as antimalarials. All patients will be evaluated with the RCLASI, PAGI and VAS after 12 weeks and at the end of treatment. Adverse Events (AE) will be recorded at each visit until 4 weeks after the end of therapy. Serious Adverse Events (SAE) must be reported if they occur up to 4 weeks after the end of therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Cutaneous
Keywords
C17.300.475, C17.800.480

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fumaric acid esters
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fumaric acid esters
Other Intervention Name(s)
Fumaderm® initial, Fumaderm®
Intervention Description
Starting from 1 tablet Fumaderm® initial per day, with titration up to 6 tablets Fumaderm® per day; in case of side effects, the dose will be adapted to the highest tolerable levels
Primary Outcome Measure Information:
Title
Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely.
Description
Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50").
Time Frame
Week 24 or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).
Secondary Outcome Measure Information:
Title
Proportion of patients with RCLASI 50 at week 12 of treatment
Time Frame
Week 12 of treatment
Title
Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions)
Time Frame
End of therapy (up to 24 weeks)
Title
Time from start of treatment to first RCLASI 50 assessment (time to response).
Time Frame
Time to response (up to 24 weeks)
Title
Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment and at the end of therapy.
Time Frame
12 weeks after the beginning of treatment and at the end of therapy (up to 24 weeks).
Title
Number of Participants with Adverse Events (AEs) and their severity.
Time Frame
24 weeks of treatment + 4 weeks of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 preferably, 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. 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 tolbutamide; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annegret Kuhn, Prof. Dr.
Organizational Affiliation
Department of Dermatology, University Hospital Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, University Hospital Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

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Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus

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