AliCLE: Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus

Sponsor

University Hospital Muenster (Other)

Overall Status

Terminated

CT.gov ID

NCT01407679

Collaborator

Basilea Pharmaceutica International Ltd (Industry)

Enrollment

Locations

Arm

Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 patients who withdrew prematurely. Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50").

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Cutaneous	Drug: Alitretinoin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alitretinoin	Drug: Alitretinoin 1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur Other Names: Alitretinoin 30 mg soft capsules Alitretinoin 10 mg soft capsules

Arm

Intervention/Treatment

Experimental: Alitretinoin

Drug: Alitretinoin

1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur

Other Names:

Alitretinoin 30 mg soft capsules

Alitretinoin 10 mg soft capsules

Outcome Measures

Primary Outcome Measures

Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely. [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. [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)]
Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment. [12 weeks after the beginning of treatment]
Number of Participants with Adverse Events (AEs) and their severity. [24 weeks of treatment + 5 weeks of follow up]
Patient's global assessment and VAS for itch and pain at the end of therapy. [End of therapy (up to 24 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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;

Exclusion Criteria:

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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dematology, University Hospital	Mannheim	Baden-Wuerttemberg	Germany	68167
2	Department of Dermatology, Ludwig-Maximilians University	Muenchen	Bayern	Germany	80337
3	Department of Dermatology, University Hospital	Muenster	Westfalen	Germany	48149