Lupus Erythematosus, CutaneousPhase 2FumaCLENCT01352988
Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus
A Phase 2 study testing Fumaric acid esters in people with Lupus Erythematosus, Cutaneous, run by University Hospital Muenster at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Erythematosus, Cutaneous
- What is being tested?
- Fumaric acid esters
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, University Hospital Muenster
Münster, 48149
About this study
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
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).
Read the 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.
- Conditions
- Lupus Erythematosus, Cutaneous
- Being tested
- Fumaric acid esters
- Keywords
- C17.300.475, C17.800.480
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fumaric acid estersDrug
Also called Fumaderm® initial, Fumaderm®
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
| Study group | Role | What they receive |
|---|---|---|
| Fumaric acid esters | Experimental | Not described Receives: Drug: Fumaric acid esters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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
Measured: 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)
Measured: End of therapy (up to 24 weeks)
Time from start of treatment to first RCLASI 50 assessment (time to response).
Measured: 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.
Measured: 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.
Measured: 24 weeks of treatment + 4 weeks of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Kuhn, Prof. Dr., Principal investigator, Department of Dermatology, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352988
- Sponsor's protocol ID
- UKM 10_0020
- Acronym
- FumaCLE
- Status last verified
- Feb 2014
- First submitted
- 29 Apr 2011
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01352988
- Acronym / sponsor ID
- FumaCLE / UKM 10_0020
- Conditions
- Lupus Erythematosus, Cutaneous
- Keywords
- C17.300.475, C17.800.480
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fumaric acid esters | Experimental | Drug: Fumaric acid esters |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fumaric acid estersAlso: Fumaderm® initial, Fumaderm®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 | Drug | Fumaric acid esters |
Primary outcome
Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely.
Time frame: 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").
5 secondary outcomes
Proportion of patients with RCLASI 50 at week 12 of treatment
Time frame: 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 frame: End of therapy (up to 24 weeks)
Time from start of treatment to first RCLASI 50 assessment (time to response).
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks of treatment + 4 weeks of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Kuhn, Prof. Dr. principal investigator
Department of Dermatology, University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fumaric acid esters in people with Lupus Erythematosus, Cutaneous, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely. (time frame: Week 24 or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.