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

NCT ID: NCT01407679

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-04-30

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").

Conditions

Lupus Erythematosus, Cutaneous

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alitretinoin

Group Type: EXPERIMENTAL

Alitretinoin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Alitretinoin 30 mg soft capsules; Alitretinoin 10 mg soft capsules

Eligibility Criteria

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:

1. Fasting triglyceridemia > 1.5 x upper limit of normal (ULN)

2. Fasting total cholesterol > 1.5 x ULN

3. 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basilea Pharmaceutica International Ltd

INDUSTRY

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annegret Kuhn, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University Hospital Muenster, Muenster, Germany

Locations

Department of Dematology, University Hospital

Mannheim, Baden-Wurttemberg, Germany

Department of Dermatology, Ludwig-Maximilians University

Munich, Bavaria, Germany

Department of Dermatology, University Hospital

Münster, Westfalen, Germany

Countries

Germany

Other Identifiers

UKM 10_0019

Identifier Type: -

Identifier Source: org_study_id