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

NCT01352988 | Completed Phase 2

• 1 other identifier: UKM 10_0020
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Lupus Erythematosus, Cutaneous

Keywords

C17.300.475; C17.800.480

Outcome Measures

Primary Outcomes (1)

• 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").

  Week 24 or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).

Secondary Outcomes (5)

• Proportion of patients with RCLASI 50 at week 12 of treatment

  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)

  End of therapy (up to 24 weeks)

• Time from start of treatment to first RCLASI 50 assessment (time to response).

  Time to response (up to 24 weeks)

• Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment and at the end of therapy.

  12 weeks after the beginning of treatment and at the end of therapy (up to 24 weeks).

• Number of Participants with Adverse Events (AEs) and their severity.

  24 weeks of treatment + 4 weeks of follow up

Study Arms (1)

Fumaric acid esters

EXPERIMENTAL

Drug: Fumaric acid esters

Interventions

Fumaric acid esters DRUG

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

Also known as: Fumaderm® initial, Fumaderm®

Fumaric acid esters

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Department of Dermatology, University Hospital Muenster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Interventions

Fumarates; Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Annegret Kuhn, Prof. Dr.

  Department of Dermatology, University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 12, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

DE (1)