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

Primary Purpose

Lupus Erythematosus, Cutaneous

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Alitretinoin
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Cutaneous focused on measuring cutaneous lupus erythematosus, discoid lupus erythematosus, subacute cutaneous lupus erythematosus, lupus erythematosus tumidus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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:

    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

Sites / Locations

  • Department of Dematology, University Hospital
  • Department of Dermatology, Ludwig-Maximilians University
  • Department of Dermatology, University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alitretinoin

Arm Description

Outcomes

Primary Outcome Measures

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")

Secondary Outcome Measures

Proportion of patients with RCLASI 50 at 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).
Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment.
Number of Participants with Adverse Events (AEs) and their severity.
Patient's global assessment and VAS for itch and pain at the end of therapy.

Full Information

First Posted
August 1, 2011
Last Updated
May 30, 2016
Sponsor
University Hospital Muenster
Collaborators
Basilea Pharmaceutica International Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01407679
Brief Title
Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster
Collaborators
Basilea Pharmaceutica International Ltd

4. Oversight

Data Monitoring Committee
No

5. 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").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Cutaneous
Keywords
cutaneous lupus erythematosus, discoid lupus erythematosus, subacute cutaneous lupus erythematosus, lupus erythematosus tumidus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alitretinoin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Alitretinoin
Other Intervention Name(s)
Alitretinoin 30 mg soft capsules, Alitretinoin 10 mg soft capsules
Intervention Description
1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
Primary Outcome Measure Information:
Title
Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely.
Description
Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50")
Time Frame
Week 24 or at the latest assessment for patients who withdrew prematurely.
Secondary Outcome Measure Information:
Title
Proportion of patients with RCLASI 50 at week 12 of treatment.
Time Frame
Week 12 of treatment
Title
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)
Title
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
Title
Number of Participants with Adverse Events (AEs) and their severity.
Time Frame
24 weeks of treatment + 5 weeks of follow up
Title
Patient's global assessment and VAS for itch and pain at the end of therapy.
Time Frame
End of therapy (up to 24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annegret Kuhn, Prof. Dr.
Organizational Affiliation
Department of Dermatology, University Hospital Muenster, Muenster, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dematology, University Hospital
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Department of Dermatology, Ludwig-Maximilians University
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
Department of Dermatology, University Hospital
City
Muenster
State/Province
Westfalen
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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