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

Lupus Erythematosus, Cutaneous Clinical Trial

— AliCLE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01407679
• Other study ID #: UKM 10_0019
• Status: Terminated
• Phase: Phase 2
• First received: August 1, 2011
• Last updated: May 30, 2016
• Start date: August 2011
• Est. completion date: April 2014

Study information

• Verified date: May 2016
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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;

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Dematology, University Hospital	Mannheim	Baden-Wuerttemberg
Germany	Department of Dermatology, Ludwig-Maximilians University	Muenchen	Bayern
Germany	Department of Dermatology, University Hospital	Muenster	Westfalen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Basilea Pharmaceutica International Ltd

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Proportion of patients with RCLASI 50 at week 12 of treatment.		Week 12 of treatment	No
Secondary	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)	No
Secondary	Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment.		12 weeks after the beginning of treatment	No
Secondary	Number of Participants with Adverse Events (AEs) and their severity.		24 weeks of treatment + 5 weeks of follow up	Yes
Secondary	Patient's global assessment and VAS for itch and pain at the end of therapy.		End of therapy (up to 24 weeks)	No