Lupus Erythematosus, CutaneousPhase 2AliCLENCT01407679
Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus
A Phase 2 study testing Alitretinoin in people with Lupus Erythematosus, Cutaneous, run by University Hospital Muenster at 3 sites in Germany.
Trial summary
To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Erythematosus, Cutaneous
- What is being tested?
- Alitretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesGermany
- Study dates
- Aug 2011to Apr 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 75 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) who failed to respond to topical corticosteroids;
- Total RCLASI activity score of skin lesions >6 (at least 3 points in at least 2 locations);
- At least one primary but preferably 2 methods of contraception;
Who cannot join
- Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease;
- 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;
- Patients with hepatic insufficiency (AST, ALT > 2.5 x ULN), severe renal failure (creatinine clearance < 60ml/min), or hypercholesterolemia characterized by:
- Fasting triglyceridemia > 1.5 x upper limit of normal (ULN)
- Fasting total cholesterol > 1.5 x ULN
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- Fasting low-density lipoprotein (LDL) cholesterol > 1.5x ULN
- Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil;
- Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin;
- Topical corticosteroids within 14 days prior to dosing;
- Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment;
- Drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John"s Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment;
- 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 and half-life);
- Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
- Concomitant medication 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;
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Department of Dematology, University Hospital
Mannheim, Baden-Wurttemberg, 68167
Department of Dermatology, Ludwig-Maximilians University
Munich, Bavaria, 80337
Department of Dermatology, University Hospital
Münster, Westfalen, 48149
About this study
Official title: Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study
To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE 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. Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50").
- Conditions
- Lupus Erythematosus, Cutaneous
- Being tested
- Alitretinoin
- Keywords
- cutaneous lupus erythematosus, discoid lupus erythematosus, subacute cutaneous lupus erythematosus, lupus erythematosus tumidus
- Medical subject headings
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlitretinoinDrug
Also called Alitretinoin 30 mg soft capsules, Alitretinoin 10 mg soft capsules
1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
| Study group | Role | What they receive |
|---|---|---|
| Alitretinoin | Experimental | Not described Receives: Drug: Alitretinoin |
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.
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)
Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment.
Measured: 12 weeks after the beginning of treatment
Number of Participants with Adverse Events (AEs) and their severity.
Measured: 24 weeks of treatment + 5 weeks of follow up
Patient's global assessment and VAS for itch and pain at the end of therapy.
Measured: End of therapy (up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2014
- Study completionApr 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Basilea Pharmaceutica International Ltd
- Responsible party
- Sponsor
- Investigators
- Annegret Kuhn, Prof. Dr., Principal investigator, Department of Dermatology, University Hospital Muenster, Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407679
- Sponsor's protocol ID
- UKM 10_0019
- Acronym
- AliCLE
- Status last verified
- May 2016
- First submitted
- 1 Aug 2011
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT01407679
- Acronym / sponsor ID
- AliCLE / UKM 10_0019
- Conditions
- Lupus Erythematosus, Cutaneous
- Keywords
- cutaneous lupus erythematosus, discoid lupus erythematosus, subacute cutaneous lupus erythematosus, lupus erythematosus tumidus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Basilea Pharmaceutica International Ltd
- Study start
- Aug 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Aug 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.
To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE 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. Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50").
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alitretinoin | Experimental | Drug: Alitretinoin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A clinical and histological diagnosis of CLE (DLE, SCLE, LET) who failed to respond to topical corticosteroids;
- Total RCLASI activity score of skin lesions >6 (at least 3 points in at least 2 locations);
- At least one primary but preferably 2 methods of contraception;
Key exclusion criteria (17 listed)
- Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease;
- 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;
- Patients with hepatic insufficiency (AST, ALT > 2.5 x ULN), severe renal failure (creatinine clearance < 60ml/min), or hypercholesterolemia characterized by:
- Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil;
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 |
|---|---|---|
| AlitretinoinAlso: Alitretinoin 30 mg soft capsules, Alitretinoin 10 mg soft capsules1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur | Drug | Alitretinoin |
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.
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)
Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment.
Time frame: 12 weeks after the beginning of treatment
Number of Participants with Adverse Events (AEs) and their severity.
Time frame: 24 weeks of treatment + 5 weeks of follow up
Patient's global assessment and VAS for itch and pain at the end of therapy.
Time frame: End of therapy (up to 24 weeks)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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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, Muenster, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alitretinoin in people with Lupus Erythematosus, Cutaneous, run by University Hospital Muenster at 3 sites 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 3 inclusion and 17 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: stopped early, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early. Results are not available in the source record.
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.). 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 1 Jun 2016.